Amputation, TraumaticIMESNCT01901081
Feasibility of Implantable Myoelectric Sensors to Control Upper Limb Prostheses
A study testing IMES in people with Amputation, Traumatic, run by The Alfred E. Mann Foundation for Scientific Research at 1 site in United States.
Trial summary
This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control an electromechanical prosthetic wrist and hand. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Traumatic
- What is being tested?
- IMES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a health care beneficiary at the Walter Reed National Military Medical Center.
- Patient has transradial amputation with one-third or greater residual forearm length as determined by the contralateral side.
- Patient's residual forearm anatomy (based on number and size of residual muscles) will support the implantation and control of at least six IMES (in the opinion of the Investigator). This criterion will be verified during a study-specific screening test.
- Patient is age 18 or above.
- Patient can speak and comprehend English.
- Patient is willing and capable of providing informed consent.
Show all 16Show fewer
- Patient has undergone amputee rehabilitation, including being trained to wear and use a body-powered and myoelectric prosthesis.
- Patient reports wearing an upper limb prosthesis at least two hours per day.
- Unilateral amputation with preserved function of the non-amputated arm; preserved function is investigator opinion as to whether the patient:
- has the ability to independently don and doff a prosthesis,
- has enough dexterity in the non-amputated arm to attach and detach the Prosthetic Control Interface (PCI) cable and operate the PCI power switch,
- has the dexterity to remove and replace the PCI battery.
- Patient is willing and capable of having EMG needles inserted into the forearm.
- In the opinion of the Investigator, patient is cognitively capable of operating an IMES Prosthesis.
- Patient is willing to comply with a wearing schedule for the investigational device.
- Patient is willing and capable of travelling to the investigational site for study visits outlined in this protocol.
Who cannot join
- Patient is less than three months from amputation surgery or major injury of the target residual limb.
- Patient has major injury proximal to the level of amputation.
- In the opinion of the Investigator, patient is prone to skin breakdown in the target residual limb.
- Known nerve transection or palsy that may cause de-innervation of muscles in the target residual limb.
- Known genetic neuromuscular disorder (e.g. multiple sclerosis, myasthenia gravis, muscular dystrophy).
- Patient has a bleeding or clotting disorder.
Show all 15Show fewer
- Bilateral upper extremity amputation.
- Patient has a major psychological disorder such as poorly controlled PTSD, schizophrenia, or paranoia such that cooperative status is inconsistent.
- Patient has an active implant (e.g. pacemaker, implanted cardiac defibrillator [ICD], neurostimulator, drug infusion device).
- Patients having any metal fragments or metal implants (e.g. orthopedic hardware) located within the residual forearm are excluded. The absence of metal shall be confirmed by an x-ray of the entire affected arm.
- Patients having metal in the affected upper arm will be considered on a case-by-case basis. An x-ray of the entire affected arm shall be provided to the Sponsor who will assess potential interaction of the metal with the Coil's magnetic field.
- Patient has a history of adverse reactions to anesthetic agents.
- Patient has recently or is currently participating in research that may influence response to either study intervention, or be harmful to the subject in any way.
- A female patient who is pregnant, nursing, or planning to become pregnant during the course of the study.
- In the opinion of the Investigator, the subject is not a suitable candidate for the study, for any reason such as residual limb infection, significant pain, significant proximal nerve injury or soft tissue damage, significant scarring, or poor health of the skin envelope.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
About this study
Official title: A Feasibility Study to Assess Safety and Functionality of Implantable Myoelectric Sensors for Upper Extremity Prosthetic Control in Transradial Amputees
This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control an electromechanical prosthetic wrist and hand.
Read the detailed description
The study assesses the feasibility of an advanced prosthesis control system aimed at development of a more intuitive and functional prosthetic device. Tiny (2.5 mm by 16 mm) Implantable Myoelectric Sensors (IMES) will be implanted into the residual forearm muscles of three transradial amputee subjects. These devices wirelessly transmit electrical muscle signals to an electromechanical prosthetic wrist and hand.
Following a two-week recovery from implantation of six to eight IMES into residual forearm muscles, subjects will initiate seven months of training. Subjects first train for approximately a month using a bench-top IMES system. When they receive their custom-fit IMES Prosthesis (including electromechanical wrist and hand) subjects initiate six months of additional training. Subjects will then be given the option to use the IMES Prosthesis for another sixteen months. The usability and functionality of the prosthetic system will be evaluated throughout the study.
- Conditions
- Amputation, Traumatic
- Being tested
- IMES
- Keywords
- Implantable Myoelectric Sensor, IMES, transradial, amputation, myoelectric, prosthesis, prosthetic control
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMESDevice
Also called Myoelectric Prosthetic Training
Once subjects recover from surgical implantation of IMES (approximately two weeks), they will practice IMES control using a bench-top IMES trainer for approximately a month. As soon as the subject's custom-fit IMES Prosthesis is available, it will be fitted and programmed. Subjects will then begin six months of prosthetic training. Month 1 training entails sessions with an Occupational Therapists 4-5 times per week. Months 2-6 Training entail meeting with an Occupational Therapist twice a month. During training, subject will learn how to contract residual musculature in the amputated limb to control movements of an electromechanical wrist and hand. The therapeutic goal is to develop skills needed to perform Activities of Daily Living using the IMES prosthesis.
After completing six months of training, subjects will be given the option to continue using their IMES Prosthesis for another sixteen months.
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic Training with IMES prosthesis | Experimental | Not described Receives: Device: IMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-Related Serious Adverse Events
Tabulation of Device-Related Serious Adverse Events during the course of the study.
Measured: Information collected over the course of 2 years following implant of IMES
Change in Accuracy Test score
The Accuracy Test requires subjects to execute a series of different hand movements using the IMES to control an electromechanical wrist and hand. Movements are chosen to demonstrate both independent and simultaneous control over the six different movements offered by the prosthesis: hand open/close, thumb adduct/abduct, wrist supinate/pronate. An occupation therapist will score the subject on each movement as follows: 0 = no movement observed; 1 = the intended movement was not observed, but unintended movements were observed; 2 = the intended movement was observed, in addition to unintended movements; 3 = the intended movement was observed. The change in Accuracy Scores across the nine tests completed will be presented.
During the Accuracy Test, Electromyographic(EMG) signals transmitted by the IMES will be recorded. A video camera will record the movements of the prosthesis so that this output may be associated with the input IMES signals.
Measured: test conducted nine times: upon receipt and programming of custom-fit IMES prosthesis; once per month for six months of training; 1 year following implant; and 2 years following implant
Secondary outcomes (4)
Change in Southampton Hand Assessment Procedure (SHAP) test score
The test entails a series of self-timed tasks (the participant starting and stopping the timer with the hand under test), which are divided into two sections: picking and placing eight different shaped objects and performing fourteen Activities of Daily Living (ADL). The objects are shaped to encourage the use of six standard prehensile patterns (spherical, tripod, power, lateral, tip, extension) and come in two different weights to test the participant's ability to form more powerful grips. The fourteen simulated ADLs include cutting, pouring, lifting and transferring loads. Subjects will perform the SHAP test using the IMES to control an electromechanical wrist and hand. Each task is scored based on the amount of time to complete. The change in SHAP scores across the nine tests completed will be presented.
Measured: test conducted nine times: upon receipt and programming of custom-fit IMES prosthesis; once per month for six months of training; 1 year following implant; and 2 years following implant
Change in Assessment of Capacity for Myoelectric Control (ACMC) test score
The ACMC is administered and scored based on observations of the subject as he or she is performing an everyday task using the IMES to control an electromechanical wrist and hand. Tasks will be chosen from a selection of six that include: packing a suitcase, sorting mail, mixing a ready-to-eat product, repotting a plant, assembling a ready-made project, and setting a table. During the assessment, subjects are encouraged to accomplish the task spontaneously in their usual way. The occupational therapist assesses capacity for control of the prosthesis by rating the performances on 22 items representing different aspects of control that are classified as gripping, holding, releasing, and coordinating between hands. Each subject's performance is rated with scores ranging from 0 to 3, where 0 = not capable, 1 = sometimes capable, capacity not established, 2 = capable on request, and 3 = spontaneously capable. The change in ACMC Scores across the nine tests completed will be presented.
Measured: test conducted nine times: upon receipt and programming of custom-fit IMES prosthesis; once per month for six months of training; 1 year following implant; and 2 years following implant
Change in Box and Block Test (BBT) score
The BBT measures unilateral gross manual dexterity. The BBT is composed of a wooden box divided in two compartments and 150 blocks. The subject is asked to move as many blocks as possible from one compartment of a box to another, within 60 seconds. The task is to be performed using the IMES to control an electromechanical wrist and hand. The change in BBT Score across the nine tests completed will be presented.
Measured: test conducted nine times: upon receipt and programming of custom-fit IMES prosthesis; once per month for six months of training; 1 year following implant; and 2 years following implant
IMES Satisfaction Questionnaire
Subjects will be asked to complete a questionnaire in which they rate and describe their satisfaction with different aspects of the IMES Prosthesis.
Measured: completed after six months of training following upon receipt and programming of custom-fit IMES prosthesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation, TraumaticStudies 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred E. Mann Foundation for Scientific Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul F Pasquina, MD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901081
- Sponsor's protocol ID
- CP0015B
- Acronym
- IMES
- Status last verified
- Feb 2017
- First submitted
- 20 May 2013
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Assess Safety and Functionality of Implantable Myoelectric Sensors for Upper Extremity Prosthetic Control in Transradial Amputees
- ClinicalTrials.gov ID
- NCT01901081
- Acronym / sponsor ID
- IMES / CP0015B
- Conditions
- Amputation, Traumatic
- Keywords
- Implantable Myoelectric Sensor, IMES, transradial, amputation, myoelectric, prosthesis, prosthetic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Alfred E. Mann Foundation for Scientific ResearchUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control an electromechanical prosthetic wrist and hand.
Detailed description
The study assesses the feasibility of an advanced prosthesis control system aimed at development of a more intuitive and functional prosthetic device. Tiny (2.5 mm by 16 mm) Implantable Myoelectric Sensors (IMES) will be implanted into the residual forearm muscles of three transradial amputee subjects. These devices wirelessly transmit electrical muscle signals to an electromechanical prosthetic wrist and hand.
Following a two-week recovery from implantation of six to eight IMES into residual forearm muscles, subjects will initiate seven months of training. Subjects first train for approximately a month using a bench-top IMES system. When they receive their custom-fit IMES Prosthesis (including electromechanical wrist and hand) subjects initiate six months of additional training. Subjects will then be given the option to use the IMES Prosthesis for another sixteen months. The usability and functionality of the prosthetic system will be evaluated throughout the study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prosthetic Training with IMES prosthesis | Experimental | Device: IMES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient is a health care beneficiary at the Walter Reed National Military Medical Center.
- Patient has transradial amputation with one-third or greater residual forearm length as determined by the contralateral side.
- Patient's residual forearm anatomy (based on number and size of residual muscles) will support the implantation and control of at least six IMES (in the opinion of the Investigator). This criterion will be verified during a study-specific screening test.
- Patient is age 18 or above.
- Patient can speak and comprehend English.
Key exclusion criteria (15 listed)
- Patient is less than three months from amputation surgery or major injury of the target residual limb.
- Patient has major injury proximal to the level of amputation.
- In the opinion of the Investigator, patient is prone to skin breakdown in the target residual limb.
- Known nerve transection or palsy that may cause de-innervation of muscles in the target residual limb.
- Known genetic neuromuscular disorder (e.g. multiple sclerosis, myasthenia gravis, muscular dystrophy).
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 |
|---|---|---|
| IMESAlso: Myoelectric Prosthetic TrainingOnce subjects recover from surgical implantation of IMES (approximately two weeks), they will practice IMES control using a bench-top IMES trainer for approximately a month. As soon as the subject's custom-fit IMES Prosthesis is available, it will be fitted and programmed. Subjects will then begin six months of prosthetic training. Month 1 training entails sessions with an Occupational Therapists 4-5 times per week. Months 2-6 Training entail meeting with an Occupational Therapist twice a month. During training, subject will learn how to contract residual musculature in the amputated limb to control movements of an electromechanical wrist and hand. The therapeutic goal is to develop skills needed to perform Activities of Daily Living using the IMES prosthesis. After completing six months of training, subjects will be given the option to continue using their IMES Prosthesis for another sixteen months. | Device | Prosthetic Training with IMES prosthesis |
Primary outcome
Device-Related Serious Adverse Events
Time frame: Information collected over the course of 2 years following implant of IMES
Tabulation of Device-Related Serious Adverse Events during the course of the study.
Change in Accuracy Test score
Time frame: test conducted nine times: upon receipt and programming of custom-fit IMES prosthesis; once per month for six months of training; 1 year following implant; and 2 years following implant
The Accuracy Test requires subjects to execute a series of different hand movements using the IMES to control an electromechanical wrist and hand. Movements are chosen to demonstrate both independent and simultaneous control over the six different movements offered by the prosthesis: hand open/close, thumb adduct/abduct, wrist supinate/pronate. An occupation therapist will score the subject on each movement as follows: 0 = no movement observed; 1 = the intended movement was not observed, but unintended movements were observed; 2 = the intended movement was observed, in addition to unintended movements; 3 = the intended movement was observed. The change in Accuracy Scores across the nine tests completed will be presented. During the Accuracy Test, Electromyographic(EMG) signals transmitted by the IMES will be recorded. A video camera will record the movements of the prosthesis so that this output may be associated with the input IMES signals.
4 secondary outcomes
Change in Southampton Hand Assessment Procedure (SHAP) test score
Time frame: test conducted nine times: upon receipt and programming of custom-fit IMES prosthesis; once per month for six months of training; 1 year following implant; and 2 years following implant
Change in Assessment of Capacity for Myoelectric Control (ACMC) test score
Time frame: test conducted nine times: upon receipt and programming of custom-fit IMES prosthesis; once per month for six months of training; 1 year following implant; and 2 years following implant
Change in Box and Block Test (BBT) score
Time frame: test conducted nine times: upon receipt and programming of custom-fit IMES prosthesis; once per month for six months of training; 1 year following implant; and 2 years following implant
IMES Satisfaction Questionnaire
Time frame: completed after six months of training following upon receipt and programming of custom-fit IMES prosthesis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
Related trials for Amputation, Traumatic
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Transtibial Osseointegration
Amputation; Traumatic, Leg, Lower
Recruiting
REsistance and LOADing Exercise for Bone Health
Amputation of Lower Limb Below Knee, Amputation, Traumatic
Recruiting
Pilot Trial for WounDx™ Clinical Decision Support Tool
Wounds, Wounds and Injuries
Recruiting
Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users
Lower Limb Amputation, Prosthesis Users
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.
Paul F Pasquina, MD principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMES in people with Amputation, Traumatic, run by The Alfred E. Mann Foundation for Scientific Research at 1 site 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 16 inclusion and 15 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Device-Related Serious Adverse Events (time frame: Information collected over the course of 2 years following implant of IMES). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2017.