QuadriplegiaPhase 1TDS-1NCT01124292

Evaluation of a Tongue Operated Assistive Technology for Individuals With Severe Paralysis

A Phase 1 study testing Tongue Piercing and Usability assessment in people with Quadriplegia and Spinal Cord Injury, run by Georgia Institute of Technology at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Quadriplegia, Spinal Cord Injury, ALS
What is being tested?: Tongue Piercing and Usability assessment
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 4 sitesUnited States
Study dates: May 2010to Mar 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 18-65
Able-bodied with a tongue piercing Must have had the tongue piercing for at least 3 months and still be using it
Piercing is located in the midline of the tongue between the tip and the frenulum, almost in the center of the mouth
Can understand and speak English
Have some experience in using computers
Age 18-65

Show all 22Show fewer

No overt sign of disability or neurological disease
Do not have a tongue piercing, but are willing to receive one in the midline between the tip and lingual frenulum, almost in the center of the mouth
Can understand and speak English
Have some experience in using computers
Age 18-65
Have mobility limitations requiring a power wheel chair and also have inadequate upper limb strength to manage a hand or arm control i.e. have severe motor disabilities and need alternative control
Either using or suitable for an alternative control
Able to follow simple commands
Sitting tolerance of at least 4 hours (each experiment session will be no more than 4 hours and the researcher follows the standard pressure relief schedule)
Have some experience in using computers
Be able to move the tongue
Be able to speak or respond to questions by themselves or through an augmentative and alternative communication (AAC) device
Be able to give consent
Be able to have a caregiver, who can respond immediately in the event of an emergency, available during the period of the study.
Can understand and speak English
Have or are willing to receive a tongue piercing in the midline between the tip and the lingual frenulum, almost in the center of the mouth

Who cannot join

Original tongue piercing and the insertion site is too wide.
Ongoing difficulties with current tongue jewelry
Tongue piercing not located in the correct position on the tongue
No experience with computers or illiterate
Severe hearing or visual deficiency or impairing neurological disease
Have any ongoing systemic condition deemed to be relevant by the local investigator-clinician

Show all 58Show fewer

Is pregnant
Cognitive impairment so that unable to follow simple commands
Wounds or ulcers on the head or in the mouth or on the tongue
Using sensitive electronic implantable medical device such as a deep brain stimulator or a pacemaker in the upper body
Intra-oral space occupying lesion or orthodontic appliance
Unable to come to GT or RIC on a regular basis during the study-period
Miss more than two appointments without prior notification
Unable to comply with any of the procedures in the protocol
Tongue too short or the tongue web too far extended, making tongue piercing difficult
Have a torus mandibularis or palatini or other space-occupying intra-oral lesion or orthodontic appliance
No experience with computers or illiterate
Severe hearing or visual deficiency or impairing neurological disease
Cardiovascular and respiratory diseases, artificial heart valve, congenital heart disease
On an immunosuppressive medication or otherwise immunocompromised
Diabetic or have any other ongoing systemic condition deemed to be relevant by the local investigator-clinician
Ongoing neoplastic disease other than localized basal cell or squamous cell carcinoma of the skin
Have known asthma, physical urticaria or angioedema
Have any current infectious condition
Cognitive impairment to the extent that cannot follow simple commands
Is pregnant
Wounds or ulcers on the head or in the mouth or on the tongue
Using sensitive electronic implantable medical device such as a deep brain stimulator or a pacemaker in the upper body
Space occupying orthodontic appliances
Unable to come SCA or NU for a tongue piercing, 72 hour visit and to GTB or RIC on a regular basis during the study-period
Miss more than two appointments without prior notification
Unable to comply with any of the procedures in the protocol
Unable to move the tongue
Have a large object or tube in the mouth blocking tongue motion
Tongue or tongue frenulum short or the tongue frenulum extended far forward, making tongue piercing difficult
Have a torus mandibularis or palatini or other space-occupying intra-oral lesion or orthodontic appliance
Medically or mentally unstable
Known sensitivity or allergy to an adhesive
Using a halo brace or facial pads that would block the use of a headset or headgear
Cognitive impairment to the extent that the subject cannot follow simple commands
Severe hearing or visual deficiency
Cardiovascular and respiratory diseases, artificial heart valve, congenital heart disease
On any form of anticoagulation including but not limited to warfarin, heparin, low-molecular-weight heparin, factor Xa inhibitors, aspirin, aspirin-containing products, or nonsteroidal anti-inflammatory medications that the subject's supervising attending physician states cannot be stopped during the pre-piercing period which may include not only the appropriate medication-specific washout period before the piercing but also up to 5 days after the procedure.
On an immunosuppressive or otherwise immunocompromised
Have a decubitus ulcer stage III or higher or a decubitus ulcer of any stage that is worsening.
Diabetic or have any other ongoing systemic condition, as deemed to be relevant by the local investigator-clinician
Ongoing neoplastic disease other than localized basal cell or squamous cell carcinoma of the skin
Have known asthma, physical urticaria or angioedema
Have any current infectious condition
Is pregnant
No experience with computers or illiterate
Using a sensitive electronic implantable medical device such as a deep brain stimulator or a pacemaker in the upper body
Unable to sit for 4 hours with pressure relief
Wounds or ulcers on the head or in the mouth or on the tongue
No continuous access to a caregiver
Unable to come to the SCA or NMH for a three day stay for tongue piercing and to SCA or RIC on a regular basis during the study-period
Miss more than three appointments without prior notification
Unable to comply with any of the procedures in the protocol

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Georgia Institute of Technology
Atlanta, Georgia, 30308
Shepherd Center
Atlanta, Georgia, 30309
Northwestern University
Chicago, Illinois, 60611
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Development and Translational Assessment of a Tongue-Based Assistive Neuro-Technology for Individuals With Severe Neurological Disorders

This study was intended to evaluate a new assistive neuro-technology, known as the Tongue Drive System (TDS), by its potential end-users, i.e. individuals with severe disabilities, who are the best experts for indicating the benefits and possible shortcomings of any new ANT. Our goal is to assess the acceptability and usability of the TDS for various tasks that are important in daily lives of these individuals, such as computer access, wheeled mobility, and environmental control.

Read the detailed description

A new assistive neuro-technology (ANT), called the Tongue Drive System (TDS), enables individuals with severe disability access their environment with nothing but their tongue motion. The human tongue is inherently capable of sophisticated control and manipulation tasks with many degrees of freedom. It can move rapidly and accurately within the mouth such that the tip can touch every single tooth. The direct connection between the brain and the tongue generally allows it to escape damage even in severe spinal cord injuries (SCI). Unlike the brain, the tongue is accessible, and its location inside the mouth affords a degree of privacy.

TDS consists of a magnetic tracer, the size of a lentil, attached to the tongue by gluing, implantation, or piercing. The tracer generates a magnetic field inside and around the mouth that is detected by an array of magnetic sensors mounted on a wireless headset. Tongue-movement-induced changes in the magnetic field are sent wirelessly to an ultra-mobile computer or smartphone, carried by the user, which processes and translates every tongue motion to a particular user-defined function.

Once an individual with disability is "enabled" to access a computing device, he/she can nearly do everything that an able-bodied individual can do with that device. This includes communicating, education, training, entertainment, and controlling other devices such as powered wheelchairs (PWC), assistive robotic manipulators, and other home/office appliances on a local area network (LAN). Even the individual's own natural or prosthetic limbs can be manipulated to move by functional electrical stimulation (FES).

This study was intended to evaluate the TDS by the ultimate intended users, individuals with severe disabilities, who are the best experts for indicating the benefits and possible shortcomings of any new ANT. Our goal is to assess the acceptability and usability of the TDS for various tasks that are important in daily life such as computer access, wheeled mobility, and environmental control.

Three groups of subjects were recruited:

Group-A: Able-bodied subjects who already have tongue piercing

Group-B: Able-bodied subjects who wanted to receive tongue piercing as part of this trial

Group-C: Subjects with high-level disability, who wanted to receive tongue piercing as part of this trial

Each group of subjects participated in a battery of tasks that quantitatively measures their performance in accessing computers and driving wheelchairs using the TDS.

We also devised acceptable procedures for receiving a magnetic tongue piercing (required in order to use the TDS), and assess its potential safety issues.

Conditions: Quadriplegia, Spinal Cord Injury, ALS
Being tested: Tongue Piercing, Usability assessment
Keywords: Disability, Quadriplegia, Paralysis, Assistive technology, Quality of life, Computer access, Wheeled mobility
Medical subject headings: Quadriplegia, Spinal Cord Injuries, Paralysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tongue PiercingProcedure or surgery
Subjects brush their teeth, and then swish and spit with chlorhexidine mouthwash for 30-60s. Subjects would be placed in a semirecumbent position in a procedure chair. After marking the piercing site using a sterilized surgical marking pen the protruded tongue would be pierced. Anesthesia may be used during the piercing at the discretion of the operator and the subject. A sterilized titanium or surgical grade stainless steel piercing tongue stud would be placed in an appropriate position on the tongue to minimize complications from the piercing but also facilitate good functionality of the TDS.
Usability assessmentDevice
Computer access: Subjects wear the TDS and get trained. Then they sit 1.5 m from a 22" LCD monitor. Then they use TDS to conduct several tasks using their tongues, such as clicking on target objects and navigating through on-screen maze, while the computer registers their tongue commands and measures their performance.
Wheelchair control: Subjects wear the TDS and use it to drive an electrically powered wheelchair through an obstacle course using their tongues. The operator measured the time it takes for the subjects to drive through the course as well as the number of collisions.

Study groups in NCT01124292
Study group	Role	What they receive
Able-bodied subject with piercing	Experimental	Able-bodied subjects who already have tongue piercing. Receives: Device: Usability assessment
Able-bodied subject without piercing	Experimental	Able-bodied subjects who willing to receive a tongue piercing for this study. Receives: Procedure: Tongue Piercing; Device: Usability assessment
Subjects with spinal cord injury	Experimental	Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing. Receives: Procedure: Tongue Piercing; Device: Usability assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput)
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second".
The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Error Rate)
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Throughput)
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second".
The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Error Rate)
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Throughput)
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second".
The high value of throughput means better performance. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Error Rate)
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Movement Time)
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The movement time is the cursor movement time from the initial movement to the final movement for each target. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Throughput)
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second".
The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Error Rate)
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
Information Transfer Rate (ITR)
Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B \&-C)1.0s,0.7s,0.5s, SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
Information Transfer Rate (Percentage of Correctly Completed Commands)
Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B \&-C)1.0s,0.7s,0.5s,SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
On-screen Maze Using TDS, Keypad, and SnP (Completion Time)
Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000.
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
On-screen Maze Using TDS, Keypad, and SnP (Sum of Deviation / 1000)
Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000.
Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
Driving a Wheelchair Using TDS vs SnP (Completion Time)
An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles.
Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions.
Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed.
Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right.
Group-A\&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks.
Measured: 24 months
Driving a Wheelchair Using TDS vs SnP (Number of Navigation Errors)
An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles.
Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions.
Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed.
Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right.
Group-A\&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks.
Measured: 24 months
Phone Dialing Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)
Randomly selected ten-digit target phone number was visually prompted on the top of the smartphone screen, and the subject entered the same number in the following line as quickly and as accurately as possible. If the wrong number was registered, then the subjects were allowed to delete the one by issuing the deleting command.At the end of the number entering, the subject needs to move the cursor at the green colored "CALL" button, in the middle of the bottom line, and it should be selected to complete the trial. The completion time and error rate were considered to evaluate the performance.
Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
Weight Shifting Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)
The TDS commands were designated to change the wheelchair mode from driving to tilting and to control the wheelchair angle. The completion time was from the initial mode change to the end of the weight shifting.
Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Measured: 24 months
Short Questionnaire at the End of Each Session Group-A&-B:5 Consecutive TDS Trials (Intervals Ranging From Two to Ten Days) Group-C:Computer and PWC Within a Week, Over 6 Weeks.
Q1.How much thought was necessary to decide where to put your tongue to issue a specific command?1:A lot,5:A Little Q2.Was the speed of the movement of the cursor on the computer screen:1:Too slow,3:Just right,5:Too fast Q3.How difficult was pointing accurately at specific targets on the computer screen?1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1: Very difficult,5:Very easy (TDS:Q4-1.Unlatched,Q4-2.Latched,Q4-3.Semi-pro,SnP:Q4-4.Latched) Q5.Was the speed of the wheelchair:1:Too slow,5:Too fast Q6.Was the movement of the wheelchair:1:Very jerky,5:Very smooth Q7.Was TDS effective in dialing phone numbers:1:Completely ineffective,5:Very effective Q8.Was TDS effective in doing the weight shift:1:Completely ineffective,5:Very effective
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Mar 2012

First posted17 May 2010 (estimated)
Study startMay 2010
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for QuadriplegiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01124292
Sponsor's protocol ID: H09240
Other IDs: 1RC1EB010915-01
Acronym: TDS-1
Status last verified: Sep 2013
First submitted: 10 May 2010
Last updated: 18 Sep 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Huo X, Ghovanloo M. Evaluation of a wireless wearable tongue-computer interface by individuals with high-level spinal cord injuries. J Neural Eng. 2010 Apr;7(2):26008. doi: 10.1088/1741-2560/7/2/026008. Epub 2010 Mar 23.
PubMed 20332552
Huo X, Ghovanloo M. Using unconstrained tongue motion as an alternative control mechanism for wheeled mobility. IEEE Trans Biomed Eng. 2009 Jun;56(6):1719-26. doi: 10.1109/TBME.2009.2018632. Epub 2009 Apr 7.
PubMed 19362901
Huo X, Wang J, Ghovanloo M. Introduction and preliminary evaluation of the Tongue Drive System: wireless tongue-operated assistive technology for people with little or no upper-limb function. J Rehabil Res Dev. 2008;45(6):921-30. doi: 10.1682/jrrd.2007.06.0096.
PubMed 19009478
Huo X, Wang J, Ghovanloo M. A magneto-inductive sensor based wireless tongue-computer interface. IEEE Trans Neural Syst Rehabil Eng. 2008 Oct;16(5):497-504. doi: 10.1109/TNSRE.2008.2003375.
PubMed 18990653
Huo X, Ghovanloo M. Using speech recognition to enhance the Tongue Drive System functionality in computer access. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:6393-6. doi: 10.1109/IEMBS.2011.6091578.
PubMed 22255801
Yousefi B, Huo X, Veledar E, Ghovanloo M. Quantitative and comparative assessment of learning in a tongue-operated computer input device. IEEE Trans Inf Technol Biomed. 2011 Sep;15(5):747-57. doi: 10.1109/TITB.2011.2158608. Epub 2011 Jun 7.
PubMed 21652288
Yousefi B, Huo X, Kim J, Veledar E, Ghovanloo M. Quantitative and comparative assessment of learning in a tongue-operated computer input device--part II: navigation tasks. IEEE Trans Inf Technol Biomed. 2012 Jul;16(4):633-43. doi: 10.1109/TITB.2012.2191793. Epub 2012 Jun 6.
PubMed 22692932
Kim J, Huo X, Minocha J, Holbrook J, Laumann A, Ghovanloo M. Evaluation of a smartphone platform as a wireless interface between tongue drive system and electric-powered wheelchairs. IEEE Trans Biomed Eng. 2012 Jun;59(6):1787-96. doi: 10.1109/TBME.2012.2194713. Epub 2012 Apr 16.
PubMed 22531737
Minocha JS, Holbrook JS, West DP, Ghovanloo M, Laumann AE. Development of a tongue-piercing method for use with assistive technology. JAMA Dermatol. 2014 Apr;150(4):453-4. doi: 10.1001/jamadermatol.2013.7165. No abstract available.
PubMed 24284925

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Translational Assessment of a Tongue-Based Assistive Neuro-Technology for Individuals With Severe Neurological Disorders
ClinicalTrials.gov ID: NCT01124292
Acronym / sponsor ID: TDS-1 / H09240
Conditions: Quadriplegia, Spinal Cord Injury, ALS
Keywords: Disability, Quadriplegia, Paralysis, Assistive technology, Quality of life, Computer access, Wheeled mobility
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Georgia Institute of TechnologyUniversity, hospital or other
Collaborators: Shepherd Center, Atlanta GA, Northwestern University, Shirley Ryan AbilityLab, University of Arizona
Study start: May 2010
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 17 May 2010 (estimated)
Results: Posted 10 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Three groups of subjects were recruited:

Group-A: Able-bodied subjects who already have tongue piercing

Group-B: Able-bodied subjects who wanted to receive tongue piercing as part of this trial

Group-C: Subjects with high-level disability, who wanted to receive tongue piercing as part of this trial

Each group of subjects participated in a battery of tasks that quantitatively measures their performance in accessing computers and driving wheelchairs using the TDS.

We also devised acceptable procedures for receiving a magnetic tongue piercing (required in order to use the TDS), and assess its potential safety issues.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Able-bodied subject with piercing	Experimental	Device: Usability assessmentAble-bodied subjects who already have tongue piercing.
Able-bodied subject without piercing	Experimental	Procedure: Tongue Piercing, Device: Usability assessmentAble-bodied subjects who willing to receive a tongue piercing for this study.
Subjects with spinal cord injury	Experimental	Procedure: Tongue Piercing, Device: Usability assessmentPersons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Age 18-65
Able-bodied with a tongue piercing Must have had the tongue piercing for at least 3 months and still be using it
Piercing is located in the midline of the tongue between the tip and the frenulum, almost in the center of the mouth
Can understand and speak English
Have some experience in using computers

Key exclusion criteria (58 listed)

Original tongue piercing and the insertion site is too wide.
Ongoing difficulties with current tongue jewelry
Tongue piercing not located in the correct position on the tongue
No experience with computers or illiterate
Severe hearing or visual deficiency or impairing neurological disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tongue PiercingSubjects brush their teeth, and then swish and spit with chlorhexidine mouthwash for 30-60s. Subjects would be placed in a semirecumbent position in a procedure chair. After marking the piercing site using a sterilized surgical marking pen the protruded tongue would be pierced. Anesthesia may be used during the piercing at the discretion of the operator and the subject. A sterilized titanium or surgical grade stainless steel piercing tongue stud would be placed in an appropriate position on the tongue to minimize complications from the piercing but also facilitate good functionality of the TDS.	Procedure or surgery	Able-bodied subject without piercing, Subjects with spinal cord injury
Usability assessmentComputer access: Subjects wear the TDS and get trained. Then they sit 1.5 m from a 22" LCD monitor. Then they use TDS to conduct several tasks using their tongues, such as clicking on target objects and navigating through on-screen maze, while the computer registers their tongue commands and measures their performance. Wheelchair control: Subjects wear the TDS and use it to drive an electrically powered wheelchair through an obstacle course using their tongues. The operator measured the time it takes for the subjects to drive through the course as well as the number of collisions.	Device	Able-bodied subject with piercing, Able-bodied subject without piercing, Subjects with spinal cord injury

Primary outcome

Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput)
Time frame: 24 months
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Error Rate)
Time frame: 24 months
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Throughput)
Time frame: 24 months
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Error Rate)
Time frame: 24 months
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Throughput)
Time frame: 24 months
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP). Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Error Rate)
Time frame: 24 months
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP). Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Movement Time)
Time frame: 24 months
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The movement time is the cursor movement time from the initial movement to the final movement for each target. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP). Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Throughput)
Time frame: 24 months
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Error Rate)
Time frame: 24 months
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Information Transfer Rate (ITR)
Time frame: 24 months
Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B \&-C)1.0s,0.7s,0.5s, SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Information Transfer Rate (Percentage of Correctly Completed Commands)
Time frame: 24 months
Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B \&-C)1.0s,0.7s,0.5s,SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
On-screen Maze Using TDS, Keypad, and SnP (Completion Time)
Time frame: 24 months
Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
On-screen Maze Using TDS, Keypad, and SnP (Sum of Deviation / 1000)
Time frame: 24 months
Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Driving a Wheelchair Using TDS vs SnP (Completion Time)
Time frame: 24 months
An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles. Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions. Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed. Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right. Group-A\&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks.
Driving a Wheelchair Using TDS vs SnP (Number of Navigation Errors)
Time frame: 24 months
An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles. Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions. Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed. Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right. Group-A\&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks.
Phone Dialing Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)
Time frame: 24 months
Randomly selected ten-digit target phone number was visually prompted on the top of the smartphone screen, and the subject entered the same number in the following line as quickly and as accurately as possible. If the wrong number was registered, then the subjects were allowed to delete the one by issuing the deleting command.At the end of the number entering, the subject needs to move the cursor at the green colored "CALL" button, in the middle of the bottom line, and it should be selected to complete the trial. The completion time and error rate were considered to evaluate the performance. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Weight Shifting Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)
Time frame: 24 months
The TDS commands were designated to change the wheelchair mode from driving to tilting and to control the wheelchair angle. The completion time was from the initial mode change to the end of the weight shifting. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Short Questionnaire at the End of Each Session Group-A&-B:5 Consecutive TDS Trials (Intervals Ranging From Two to Ten Days) Group-C:Computer and PWC Within a Week, Over 6 Weeks.
Time frame: 24 months
Q1.How much thought was necessary to decide where to put your tongue to issue a specific command?1:A lot,5:A Little Q2.Was the speed of the movement of the cursor on the computer screen:1:Too slow,3:Just right,5:Too fast Q3.How difficult was pointing accurately at specific targets on the computer screen?1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1: Very difficult,5:Very easy (TDS:Q4-1.Unlatched,Q4-2.Latched,Q4-3.Semi-pro,SnP:Q4-4.Latched) Q5.Was the speed of the wheelchair:1:Too slow,5:Too fast Q6.Was the movement of the wheelchair:1:Very jerky,5:Very smooth Q7.Was TDS effective in dialing phone numbers:1:Completely ineffective,5:Very effective Q8.Was TDS effective in doing the weight shift:1:Completely ineffective,5:Very effective

Results and safety

Results posted to the registry on 10 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Able-bodied Subject With Tongue Piercing	16	14
Able-bodied Subject Without Tongue Piercing	24	9
Subjects With Spinal Cord Injury	21	11

Primary outcome: Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput)

Time frame: 24 months. Mean (Standard Deviation). Unit: bits per second

Measure	Able-bodied Subject With Tongue Piercing (Group-A) n = 14	Able-bodied Subject Without Tongue Piercing (Group-B) n = 9	Subjects With Spinal Cord Injury (Group-C) n = 11
first session using TDS	1.97 (0.44)	2.03 (0.44)	1.54 (0.56)
second session using TDS	2.04 (0.39)	2.22 (0.52)	1.75 (0.42)
third session using TDS	2.34 (0.32)	2.48 (0.51)	1.90 (0.51)
fourth session using TDS	2.37 (0.50)	2.54 (0.48)	2.14 (0.54)
fifth session using TDS	2.44 (0.52)	2.47 (0.54)	2.09 (0.41)
sixth session using TDS	NA (NA)	NA (NA)	2.22 (0.51)
first session using keypad	2.85 (0.41)	3.49 (0.68)	NA (NA)
second session using keypad	2.96 (0.45)	3.69 (0.48)	NA (NA)

Primary outcome: Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Error Rate)

Time frame: 24 months. Mean (Standard Deviation). Unit: Percentage of Missed Targets (%)

Measure	Able-bodied Subject With Tongue Piercing (Group-A) n = 14	Able-bodied Subject Without Tongue Piercing (Group-B) n = 9	Subjects With Spinal Cord Injury (Group-C) n = 11
first session using TDS	29.14 (13.96)	23.85 (11.04)	37.84 (21.65)
second session using TDS	24.08 (17.30)	18.36 (10.11)	30.62 (18.02)
third session using TDS	24.64 (14.89)	13.70 (8.14)	28.77 (17.72)
fourth session using TDS	20.74 (14.36)	14.90 (9.34)	24.01 (14.16)
fifth session using TDS	17.96 (10.41)	16.34 (10.26)	18.45 (9.83)
sixth session using TDS	NA (NA)	NA (NA)	19.81 (12.63)
first session using keypad	9.49 (7.96)	10.63 (8.35)	NA (NA)
second session using keypad	6.94 (6.21)	8.44 (7.40)	NA (NA)

Primary outcome: Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Throughput)

Time frame: 24 months. Mean (Standard Deviation). Unit: bits per second

Measure	Able-bodied Subject With Tongue Piercing (Group-A) n = 14	Able-bodied Subject Without Tongue Piercing (Group-B) n = 9	Subjects With Spinal Cord Injury (Group-C) n = 11
first session using TDS	2.14 (0.41)	2.22 (0.54)	1.44 (0.50)
second session using TDS	2.27 (0.37)	2.54 (0.51)	1.77 (0.54)
third session using TDS	2.31 (0.45)	2.74 (0.30)	1.79 (0.56)
fourth session using TDS	2.44 (0.36)	2.76 (0.45)	1.97 (0.33)
fifth session using TDS	2.61 (0.30)	2.69 (0.49)	2.01 (0.43)
sixth session using TDS	NA (NA)	NA (NA)	2.18 (0.60)
first session using keypad	2.84 (0.44)	3.46 (0.61)	NA (NA)
second session using keypad	2.90 (0.56)	3.88 (0.58)	NA (NA)

Primary outcome: Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Error Rate)

Time frame: 24 months. Mean (Standard Deviation). Unit: Percentage of Missed Targets (%)

Measure	Able-bodied Subject With Tongue Piercing (Group-A) n = 14	Able-bodied Subject Without Tongue Piercing (Group-B) n = 9	Subjects With Spinal Cord Injury (Group-C) n = 11
first session using TDS	26.16 (15.39)	19.47 (9.95)	38.95 (19.61)
second session using TDS	21.83 (13.78)	15.88 (11.74)	30.37 (17.31)
third session using TDS	22.72 (12.43)	12.67 (7.52)	26.67 (15.57)
fourth session using TDS	20.30 (13.55)	10.97 (10.06)	23.77 (11.32)
fifth session using TDS	14.77 (11.79)	10.97 (7.71)	21.90 (11.35)
sixth session using TDS	NA (NA)	NA (NA)	19.99 (12.44)
first session using keypad	9.91 (8.92)	10.43 (7.80)	NA (NA)
second session using keypad	8.95 (7.91)	8.26 (5.72)	NA (NA)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Able-bodied Subject With Tongue Piercing (Group-A)	0 of 16 (0%)	0 of 16 (0%)	Not reported
Able-bodied Subject Without Tongue Piercing (Group-B)	0 of 24 (0%)	0 of 24 (0%)	Not reported
Subjects With Spinal Cord Injury (Group-C)	0 of 21 (0%)	0 of 21 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20332552Huo X, Ghovanloo M. Evaluation of a wireless wearable tongue-computer interface by individuals with high-level spinal cord injuries. J Neural Eng. 2010 Apr;7(2):26008. doi: 10.1088/1741-2560/7/2/026008. Epub 2010 Mar 23.
Background: PubMed 19362901Huo X, Ghovanloo M. Using unconstrained tongue motion as an alternative control mechanism for wheeled mobility. IEEE Trans Biomed Eng. 2009 Jun;56(6):1719-26. doi: 10.1109/TBME.2009.2018632. Epub 2009 Apr 7.
Background: PubMed 19009478Huo X, Wang J, Ghovanloo M. Introduction and preliminary evaluation of the Tongue Drive System: wireless tongue-operated assistive technology for people with little or no upper-limb function. J Rehabil Res Dev. 2008;45(6):921-30. doi: 10.1682/jrrd.2007.06.0096.
Background: PubMed 18990653Huo X, Wang J, Ghovanloo M. A magneto-inductive sensor based wireless tongue-computer interface. IEEE Trans Neural Syst Rehabil Eng. 2008 Oct;16(5):497-504. doi: 10.1109/TNSRE.2008.2003375.
Background: PubMed 22255801Huo X, Ghovanloo M. Using speech recognition to enhance the Tongue Drive System functionality in computer access. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:6393-6. doi: 10.1109/IEMBS.2011.6091578.
Results publication: PubMed 21652288Yousefi B, Huo X, Veledar E, Ghovanloo M. Quantitative and comparative assessment of learning in a tongue-operated computer input device. IEEE Trans Inf Technol Biomed. 2011 Sep;15(5):747-57. doi: 10.1109/TITB.2011.2158608. Epub 2011 Jun 7.
Results publication: PubMed 22692932Yousefi B, Huo X, Kim J, Veledar E, Ghovanloo M. Quantitative and comparative assessment of learning in a tongue-operated computer input device--part II: navigation tasks. IEEE Trans Inf Technol Biomed. 2012 Jul;16(4):633-43. doi: 10.1109/TITB.2012.2191793. Epub 2012 Jun 6.
Results publication: PubMed 22531737Kim J, Huo X, Minocha J, Holbrook J, Laumann A, Ghovanloo M. Evaluation of a smartphone platform as a wireless interface between tongue drive system and electric-powered wheelchairs. IEEE Trans Biomed Eng. 2012 Jun;59(6):1787-96. doi: 10.1109/TBME.2012.2194713. Epub 2012 Apr 16.
Derived from this study: PubMed 24284925Minocha JS, Holbrook JS, West DP, Ghovanloo M, Laumann AE. Development of a tongue-piercing method for use with assistive technology. JAMA Dermatol. 2014 Apr;150(4):453-4. doi: 10.1001/jamadermatol.2013.7165. No abstract available.
CNN report on the first clinical trial of the Tongue Drive System at the Shepherd Center in 2009Link provided by the sponsor.
Tongue Drive System featured on the Science Nation (the National Science Foundation online Magazine), showing a short video clip of the first clinical trial at the Shepherd Center in Atlanta.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maysam Ghovanloo, Ph.D. principal investigator

Georgia Institute of Technology

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tongue Piercing and Usability assessment in people with Quadriplegia and Spinal Cord Injury, run by Georgia Institute of Technology at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 58 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput) (time frame: 24 months). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01124292, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.