Vestibular DisorderNCT02735096
Testing an Intraoral Electronic Balance Aid for Vestibular Imbalance
A study testing EquiCue (Intraoral Electronic Balance Aid) in people with Vestibular Disorder, run by Innervo Technology LLC at 2 sites in United States.
Trial summary
The human body uses vestibular feedback in coordination with visual and somatosensory information to maintain balance and posture. However, various inner-ear disorders due to aging, drug toxicity, viral infections, and injury, etc., may result in loss of vestibular feedback, which makes it difficult for an individual… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- EquiCue (Intraoral Electronic Balance Aid)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2016to Oct 2016
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking adults with ages between 18-85.
- Patients with imbalance resulted from vestibular loss or vestibulopathy.
- Priority given to those who took vestibular rehabilitation therapy but without satisfactory improvement.
Who cannot join
- Inability to follow instructions.
- Any visible abnormalities on the hard palate that prevent use of the palatal device.
- Any mental or physical illness beyond the secondary effects of vestibular loss that prevent recognition or effective use of the alternative feedback.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MU ENT Hearing and Balance Center
Columbia, Missouri, 65201
Blue Ridge Physical Therapy
Independence, Missouri, 64055
About this study
Official title: Palatal Device Providing In-situ Sensory Feedback for Patients With Vestibular Imbalance
The human body uses vestibular feedback in coordination with visual and somatosensory information to maintain balance and posture. However, various inner-ear disorders due to aging, drug toxicity, viral infections, and injury, etc., may result in loss of vestibular feedback, which makes it difficult for an individual to maintain balance. This study investigates the use of a hidden and noninvasive balance device EquiCue™ V1 developed by Innervo Technology for vestibular substitution. EquiCue™ V1 is a retainer-like intraoral electronic balance aid entirely worn inside the oral cavity and provides in-situ sensory feedback of head tilting and motion on the roof of the mouth. The feedback is delivered by applying small and controlled electrical pulses at precise locations on the palatal surface according to an encoded pattern. This pilot study is to determine how this alternative sensory feedback on the roof of the mouth can be used to improve balance for patients with vestibular loss.
Read the detailed description
Background
Vestibular imbalance is prevalent in the United States and around the world. According to NIDCD, 4% (8 million) of American adults report a chronic problem with balance (visit vestibular.org for more information). The leading cause of imbalance is vestibular dysfunction. Various vestibular disorders due to aging, diseases, ototoxicity, and injuries, etc. can cause damage or degradation of the vestibular system, resulting in loss of vestibular feedback. Symptoms associated with vestibular loss include: difficulty maintaining straight posture; stumbling or unable to walk straight; lose balance on uneven surfaces or under dim lighting; floating sensation and tendency to look downward to confirm the location of the ground. Vestibular imbalance greatly increases risk of falling and has such disabling effects ranging from reduced activity levels to total loss of mobility.
Vestibular rehabilitation therapies (VRT) may help vestibular patients to compensate with vision and proprioception. However, such compensation is not adequate because the brain often needs a reliable reference in order to use visual and somatosensory information for perception of self-motion and spatial orientation. Consequently, many patients with vestibular imbalance fail to compensate, especially those with profound vestibular loss. Even those who respond to VRT may experience constant physical and mental stress due to overreliance on vision and proprioception that can be misleading in busy environments.
EquiCue™ Intraoral Balance Aid
The intraoral balance aid EquiCue™ V1 is a hidden and noninvasive balance device that vestibular patients can use in various indoor and outdoor activities. It is a retainer-like device entirely worn inside the oral cavity, with no need of surgical implantation, and can be removed when not in use. The device provides in-situ sensory feedback of head tilt and motion by applying small electrical pulses on the roof of the mouth. By sensing the feedback from the device, an individual with vestibular loss can have better judgment of the tilt and motion of the head and make physical adjustment accordingly for better balance of the body. Since the device does not cause alteration to the appearance of the user, patients may use it in public places such as shopping malls, supermarkets, and metro stations, while offering balance assistance and improved postural stability and gait in these busy environments.
Human Subject Study
The current study is an initial stage of a clinical trial on the use of EquiCue™ for patients with vestibular imbalance. The hypothesis is that EquiCue™ can at least partially substitute the lost vestibular function and therefore helps a vestibular patient to achieve better postural stability in daily activities. The basic questions regarding the technology are: 1) How to represent head movement using electrical pulses on the palate; 2) Whether the electrotactile presentation on the palate can be reliably recognized and used for balance control. The study also helps to understand the role of multisensory integration on balance, especially the impact of alternative sensory feedback on the balance system.
Subjects participating in the study will be expected to wear a custom-made retainer-like device and perform movements to test their balance. If a patient is determined to be a suitable subject, the sensitivity profile on the palate of the patient will be measured. After an EquiCue™ intraoral device is custom made, the patient will be asked to fit the device inside the mouth, and verify the basic functionality of the device by identifying direction, perceived intensity, and sensory characteristics of stimuli from the device. The subject will then go through 3-4 sessions of training and testing in which the subject tries to associate the feedback with head movement and to integrate the feedback with other senses to achieve a better spatial orientation and balance. The improvement in balance and gait with the device will be evaluated by using standard tests on balance platforms (Computerized Dynamic Posturography) and Dynamic Gait Index. Tests will be made without wearing the device at the beginning and wearing the device at the end of each training session.
- Conditions
- Vestibular Disorder
- Being tested
- EquiCue (Intraoral Electronic Balance Aid)
- Keywords
- Bilateral Vestibular Hypofunction, Unilateral Vestibular Hypofunction, Imbalance
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EquiCue (Intraoral Electronic Balance Aid)Device
Also called EquiCue
When the device is worn, a subject will receive small electrical pulses on roof of the mouth as alternative feedback of head tilting or movement.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Patients for EquiCue Testing | Experimental | Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance. Receives: Device: EquiCue (Intraoral Electronic Balance Aid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equilibrium Score
Equilibrium scores for each trial for each condition from Sensory Organization Test (EquiTest). Conditions: 1-6; with or without using EquiCue intraoral balance aid. Equilibrium scores were generated from the EquiTest CDP (computerized dynamic posturography) platform to assess standing balance of a patient ranging from 0 (all falls) to 100 (perfect balance with no sway), with higher scores indicating better balance performance. An equilibrium score of 70 and above is considered normal.
Measured: July 2016 - October 2016 (~ 4 months)
Secondary outcomes (3)
Perceived Intensity Level
The perceived Intensity level (from 0 to 5) as judged by a patient in response to pulsed stimuli applied on the palatal surface after adjustment of device settings for that patient. 1 - barely perceptible, 2 - weak, 3 - good, 4 - strong, 5 - painful.
Measured: July 2016 - October 2016 (~ 4 months)
Dynamic Gait Index
A subject's gait is evaluated by a physical therapist when no device is worn and when alternative sensory feedback of head movement is presented to the patient using the device. 7 walking exercises were administrated for each DGI test, with a score in the range of 0 - 3 (0 for severely impaired and 3 for normal gait) for each exercise, and a total score in the range of 0 - 21 for each test.
Measured: July 2016 - October 2016 (~ 4 months)
Analog Visual Scale for the Perceived Frequency of Stimulation Pulses
A patient's assessment of the speed of pulses to quantify perceptual difference in the pulse frequencies of the feedback on the palatal surface.
Measured: July 2016 - October 2016 (~ 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Funding ended at the end of 2016
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 (7)Papers the sponsor has linked to this study.
- Other trials for Vestibular DisorderStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innervo Technology LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Missouri-Columbia, Blue Ridge Physical Therapy
- Responsible party
- Sponsor
- Investigators
- Hui Tang, Ph.D, Study director, Innervo Technology LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735096
- Sponsor's protocol ID
- ICTP216
- Status last verified
- Mar 2018
- First submitted
- 30 Mar 2016
- Last updated
- 8 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Participants' age and history of illness (i.e., vestibular loss) will be shared. However, no personal identifiable information will be collected and shared.
Publications
Tang H, Beebe DJ. An oral tactile interface for blind navigation. IEEE Trans Neural Syst Rehabil Eng. 2006 Mar;14(1):116-23. doi: 10.1109/TNSRE.2005.862696.
PubMed 16562639Tang H; Beebe DJ. Design and microfabrication of a flexible oral electrotactile display. Journal of Microelectromechanical Systems. 2003 Feb;12(1):29-36.
Danilov YP, Tyler ME, Skinner KL, Hogle RA, Bach-y-Rita P. Efficacy of electrotactile vestibular substitution in patients with peripheral and central vestibular loss. J Vestib Res. 2007;17(2-3):119-30.
PubMed 18413905Dozza M, Horak FB, Chiari L. Auditory biofeedback substitutes for loss of sensory information in maintaining stance. Exp Brain Res. 2007 Mar;178(1):37-48. doi: 10.1007/s00221-006-0709-y. Epub 2006 Oct 5.
PubMed 17021893Wall C 3rd, Merfeld DM, Rauch SD, Black FO. Vestibular prostheses: the engineering and biomedical issues. J Vestib Res. 2002-2003;12(2-3):95-113.
PubMed 12867668Brown KE, Whitney SL, Wrisley DM, Furman JM. Physical therapy outcomes for persons with bilateral vestibular loss. Laryngoscope. 2001 Oct;111(10):1812-7. doi: 10.1097/00005537-200110000-00027.
PubMed 11801950Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009 May 25;169(10):938-44. doi: 10.1001/archinternmed.2009.66.
PubMed 19468085
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palatal Device Providing In-situ Sensory Feedback for Patients With Vestibular Imbalance
- ClinicalTrials.gov ID
- NCT02735096
- Acronym / sponsor ID
- ICTP216
- Conditions
- Vestibular Disorder
- Keywords
- Bilateral Vestibular Hypofunction, Unilateral Vestibular Hypofunction, Imbalance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended at the end of 2016
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Innervo Technology LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Missouri-Columbia, Blue Ridge Physical Therapy
- Study start
- Jul 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Posted 8 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The human body uses vestibular feedback in coordination with visual and somatosensory information to maintain balance and posture. However, various inner-ear disorders due to aging, drug toxicity, viral infections, and injury, etc., may result in loss of vestibular feedback, which makes it difficult for an individual to maintain balance. This study investigates the use of a hidden and noninvasive balance device EquiCue™ V1 developed by Innervo Technology for vestibular substitution. EquiCue™ V1 is a retainer-like intraoral electronic balance aid entirely worn inside the oral cavity and provides in-situ sensory feedback of head tilting and motion on the roof of the mouth. The feedback is delivered by applying small and controlled electrical pulses at precise locations on the palatal surface according to an encoded pattern. This pilot study is to determine how this alternative sensory feedback on the roof of the mouth can be used to improve balance for patients with vestibular loss.
Detailed description
Background
Vestibular imbalance is prevalent in the United States and around the world. According to NIDCD, 4% (8 million) of American adults report a chronic problem with balance (visit vestibular.org for more information). The leading cause of imbalance is vestibular dysfunction. Various vestibular disorders due to aging, diseases, ototoxicity, and injuries, etc. can cause damage or degradation of the vestibular system, resulting in loss of vestibular feedback. Symptoms associated with vestibular loss include: difficulty maintaining straight posture; stumbling or unable to walk straight; lose balance on uneven surfaces or under dim lighting; floating sensation and tendency to look downward to confirm the location of the ground. Vestibular imbalance greatly increases risk of falling and has such disabling effects ranging from reduced activity levels to total loss of mobility.
Vestibular rehabilitation therapies (VRT) may help vestibular patients to compensate with vision and proprioception. However, such compensation is not adequate because the brain often needs a reliable reference in order to use visual and somatosensory information for perception of self-motion and spatial orientation. Consequently, many patients with vestibular imbalance fail to compensate, especially those with profound vestibular loss. Even those who respond to VRT may experience constant physical and mental stress due to overreliance on vision and proprioception that can be misleading in busy environments.
EquiCue™ Intraoral Balance Aid
The intraoral balance aid EquiCue™ V1 is a hidden and noninvasive balance device that vestibular patients can use in various indoor and outdoor activities. It is a retainer-like device entirely worn inside the oral cavity, with no need of surgical implantation, and can be removed when not in use. The device provides in-situ sensory feedback of head tilt and motion by applying small electrical pulses on the roof of the mouth. By sensing the feedback from the device, an individual with vestibular loss can have better judgment of the tilt and motion of the head and make physical adjustment accordingly for better balance of the body. Since the device does not cause alteration to the appearance of the user, patients may use it in public places such as shopping malls, supermarkets, and metro stations, while offering balance assistance and improved postural stability and gait in these busy environments.
Human Subject Study
The current study is an initial stage of a clinical trial on the use of EquiCue™ for patients with vestibular imbalance. The hypothesis is that EquiCue™ can at least partially substitute the lost vestibular function and therefore helps a vestibular patient to achieve better postural stability in daily activities. The basic questions regarding the technology are: 1) How to represent head movement using electrical pulses on the palate; 2) Whether the electrotactile presentation on the palate can be reliably recognized and used for balance control. The study also helps to understand the role of multisensory integration on balance, especially the impact of alternative sensory feedback on the balance system.
Subjects participating in the study will be expected to wear a custom-made retainer-like device and perform movements to test their balance. If a patient is determined to be a suitable subject, the sensitivity profile on the palate of the patient will be measured. After an EquiCue™ intraoral device is custom made, the patient will be asked to fit the device inside the mouth, and verify the basic functionality of the device by identifying direction, perceived intensity, and sensory characteristics of stimuli from the device. The subject will then go through 3-4 sessions of training and testing in which the subject tries to associate the feedback with head movement and to integrate the feedback with other senses to achieve a better spatial orientation and balance. The improvement in balance and gait with the device will be evaluated by using standard tests on balance platforms (Computerized Dynamic Posturography) and Dynamic Gait Index. Tests will be made without wearing the device at the beginning and wearing the device at the end of each training session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vestibular Patients for EquiCue Testing | Experimental | Device: EquiCue (Intraoral Electronic Balance Aid)Subjects with vestibular deficiency will try the intraoral electronic balance aid to see whether there is improvement in balance. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking adults with ages between 18-85.
- Patients with imbalance resulted from vestibular loss or vestibulopathy.
- Priority given to those who took vestibular rehabilitation therapy but without satisfactory improvement.
Key exclusion criteria (3 listed)
- Inability to follow instructions.
- Any visible abnormalities on the hard palate that prevent use of the palatal device.
- Any mental or physical illness beyond the secondary effects of vestibular loss that prevent recognition or effective use of the alternative feedback.
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 |
|---|---|---|
| EquiCue (Intraoral Electronic Balance Aid)Also: EquiCueWhen the device is worn, a subject will receive small electrical pulses on roof of the mouth as alternative feedback of head tilting or movement. | Device | Vestibular Patients for EquiCue Testing |
Primary outcome
Equilibrium Score
Time frame: July 2016 - October 2016 (~ 4 months)
Equilibrium scores for each trial for each condition from Sensory Organization Test (EquiTest). Conditions: 1-6; with or without using EquiCue intraoral balance aid. Equilibrium scores were generated from the EquiTest CDP (computerized dynamic posturography) platform to assess standing balance of a patient ranging from 0 (all falls) to 100 (perfect balance with no sway), with higher scores indicating better balance performance. An equilibrium score of 70 and above is considered normal.
3 secondary outcomes
Perceived Intensity Level
Time frame: July 2016 - October 2016 (~ 4 months)
Dynamic Gait Index
Time frame: July 2016 - October 2016 (~ 4 months)
Analog Visual Scale for the Perceived Frequency of Stimulation Pulses
Time frame: July 2016 - October 2016 (~ 4 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16562639Tang H, Beebe DJ. An oral tactile interface for blind navigation. IEEE Trans Neural Syst Rehabil Eng. 2006 Mar;14(1):116-23. doi: 10.1109/TNSRE.2005.862696.
- BackgroundTang H; Beebe DJ. Design and microfabrication of a flexible oral electrotactile display. Journal of Microelectromechanical Systems. 2003 Feb;12(1):29-36.
- Background: PubMed 18413905Danilov YP, Tyler ME, Skinner KL, Hogle RA, Bach-y-Rita P. Efficacy of electrotactile vestibular substitution in patients with peripheral and central vestibular loss. J Vestib Res. 2007;17(2-3):119-30.
- Background: PubMed 17021893Dozza M, Horak FB, Chiari L. Auditory biofeedback substitutes for loss of sensory information in maintaining stance. Exp Brain Res. 2007 Mar;178(1):37-48. doi: 10.1007/s00221-006-0709-y. Epub 2006 Oct 5.
- Background: PubMed 12867668Wall C 3rd, Merfeld DM, Rauch SD, Black FO. Vestibular prostheses: the engineering and biomedical issues. J Vestib Res. 2002-2003;12(2-3):95-113.
- Background: PubMed 11801950Brown KE, Whitney SL, Wrisley DM, Furman JM. Physical therapy outcomes for persons with bilateral vestibular loss. Laryngoscope. 2001 Oct;111(10):1812-7. doi: 10.1097/00005537-200110000-00027.
- Background: PubMed 19468085Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009 May 25;169(10):938-44. doi: 10.1001/archinternmed.2009.66.
- Vestibular Disorder-OverviewLink provided by the sponsor.
- The Human Balance SystemLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participants' age and history of illness (i.e., vestibular loss) will be shared. However, no personal identifiable information will be collected and shared.
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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.
Hui Tang, Ph.D study director
Innervo Technology LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EquiCue (Intraoral Electronic Balance Aid) in people with Vestibular Disorder, run by Innervo Technology LLC at 2 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2019). 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?
Equilibrium Score (time frame: July 2016 - October 2016 (~ 4 months)). 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 NCT02735096, which also lists 7 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 8 Apr 2019.