Non-disabled VolunteersEarly Phase 1NCT02358915
A Two-step Training Paradigm for Voluntary Control of the Peri-auricular Muscles
A Early Phase 1 study testing FastStart neuromuscular electrical stimulator in people with Non-disabled Volunteers and Lacking Voluntary Control of Ear Muscles, run by University of Southern California at 1 site in United States.
Trial summary
The current study intends to test the effectiveness of a two-step training paradigm for a set of skeletal muscles, which are above and behind the external portion of the ear (Peri-auricular muscles). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-disabled Volunteers, Lacking Voluntary Control of Ear Muscles
- What is being tested?
- FastStart neuromuscular electrical stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 31 Aug 2016
- Phase
- Early Phase 1
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy participants
- can't control their peri-auricular muscles at the beginning of the study (no visible movement of the ears on command).
Who cannot join
- Suffering any comorbid neuromuscular disease.
- Having a history of severe traumatic brain injury.
- Demonstrating cognitive impairment that would prevent them from providing inform consent or following the directions of the study protocol.
- Having a history of migraine headaches that could be exacerbated with the use of the electrical stimulation or the prolonged training sessions.
- Temporomandibular Joint (TMJ) dysfunction that could lead to unusual discomfort following training session.
- Having a history of prior seizure.
- Being implanted with pacemaker or defibrillators.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California-Health Sciences Campus
Los Angeles, California, 90089
About this study
The current study intends to test the effectiveness of a two-step training paradigm for a set of skeletal muscles, which are above and behind the external portion of the ear (Peri-auricular muscles).
Read the detailed description
Survivors of spinal cord injury (SCI) usually have severe mobility limitation due to their paralysis.In order to improve the independence of living for those patients, scientists and engineers invented many different types of assistive devices, such as breath controlled "sip and puff" devices, speech controlled devices, eye movement controlled devices, and head movement controlled devices. However, one limitation of the previous designs is that they all require usurping the intact function of a functional organ like mouth or eyes. A recent design by Reach Bionic's company takes advantage of a set of ear muscles-the peri-auricular muscles-that are present in more than 95% of the population, but do not serve any physiologic function in humans. These muscles are innervated by branches of cranial nerves that are controlled through the brain stem, above the spinal cord. Therefore, it is unlikely they will be affected even by a very high SCI. The design intention is to translate the ear contraction signal from the muscles into the meaningful control signal to direct a wheelchair or operate a computer cursor in a fashion to a joystick or mouse. However, since most people do not have the ability to voluntarily contract their ear muscles, the question remains how to best learn to contract our ear muscles and design an effective training paradigm.
Since norm volunteers will have the same voluntary control of their peri-auricular muscles as the patients suffering from spinal cord injury, thus, the investigators are going to test the effectiveness of our two-step training paradigm among the healthy participants at this explorative stage.
In specific, at the first step of training, participants will be asked to voluntarily contract their ear muscles with the facilitation of electrical stimulation. At the second step of training, they will take part in a computer game and will be asked to move a cursor to a specific target that will randomly appear on the computer screen. The cursor will be controlled by the electrical activities produced by the ear muscles contractions that will be captured by surface electromyography (EMG) signals.
The computer game performance of each participant before and after the second step of training with surface EMG signals feedback and the mean surface EMG signal amplitude of the auricular muscles at the maximum voluntary contraction at baseline, after the first step of training, and after the second step of training will be compared.
- Being tested
- FastStart neuromuscular electrical stimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastStart neuromuscular electrical stimulatorDevice
Also called Biosemi Active two EMG measurement system
| Study group | Role | What they receive |
|---|---|---|
| Peri-auricular muscles voluntary contraction training paradigm | Experimental | The whole training paradigm consists of two steps. At the first step of training, the electrical stimulation (FastStart neuromuscular electrical stimulator) will be applied to facilitate the voluntary contractions of the ear muscles, and the motion of the outer ear in two directions (up/down, forward/backward) will be videotaped and played back to the participants so that they can get real-time visual feedback about their ear movement. At the second step of training, surface EMG electrodes will be placed on the skin around participants' ears. During the training, they are required to move a cursor to a specific target that will randomly appear on the computer screen. The cursor will be controlled by the electrical signal from the contraction of their bilateral peri-auricular muscles. In the computer game, contraction of the left ear muscles will move the cursor to the left side and contraction of your right ear muscles will move the cursor to the right side. Receives: Device: FastStart neuromuscular electrical stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The surface EMG signal amplitude of the auricular muscles at the maximum voluntary contraction
Measured: Up to 5 weeks
Secondary outcomes (1)
The computer game performance score
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-disabled VolunteersStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolee Winstein, University of Southern California
- Investigators
- Carolee J. Winstein, Ph.D, Principal investigator, University of Southern CaliforniaBaker Lucinda, Ph.D, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358915
- Sponsor's protocol ID
- HS-14-00672
- Status last verified
- Apr 2017
- First submitted
- 29 Jan 2015
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Chanthaphun S, Heck SL, Winstein CJ, Baker L. Development of a training paradigm for voluntary control of the peri-auricular muscles: a feasibility study. J Neuroeng Rehabil. 2019 Jun 14;16(1):75. doi: 10.1186/s12984-019-0540-x.
PubMed 31200729
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-step Training Paradigm for Voluntary Control of the Peri-auricular Muscles
- ClinicalTrials.gov ID
- NCT02358915
- Acronym / sponsor ID
- HS-14-00672
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 9 Feb 2015 (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.
The current study intends to test the effectiveness of a two-step training paradigm for a set of skeletal muscles, which are above and behind the external portion of the ear (Peri-auricular muscles).
Detailed description
Survivors of spinal cord injury (SCI) usually have severe mobility limitation due to their paralysis.In order to improve the independence of living for those patients, scientists and engineers invented many different types of assistive devices, such as breath controlled "sip and puff" devices, speech controlled devices, eye movement controlled devices, and head movement controlled devices. However, one limitation of the previous designs is that they all require usurping the intact function of a functional organ like mouth or eyes. A recent design by Reach Bionic's company takes advantage of a set of ear muscles-the peri-auricular muscles-that are present in more than 95% of the population, but do not serve any physiologic function in humans. These muscles are innervated by branches of cranial nerves that are controlled through the brain stem, above the spinal cord. Therefore, it is unlikely they will be affected even by a very high SCI. The design intention is to translate the ear contraction signal from the muscles into the meaningful control signal to direct a wheelchair or operate a computer cursor in a fashion to a joystick or mouse. However, since most people do not have the ability to voluntarily contract their ear muscles, the question remains how to best learn to contract our ear muscles and design an effective training paradigm.
Since norm volunteers will have the same voluntary control of their peri-auricular muscles as the patients suffering from spinal cord injury, thus, the investigators are going to test the effectiveness of our two-step training paradigm among the healthy participants at this explorative stage.
In specific, at the first step of training, participants will be asked to voluntarily contract their ear muscles with the facilitation of electrical stimulation. At the second step of training, they will take part in a computer game and will be asked to move a cursor to a specific target that will randomly appear on the computer screen. The cursor will be controlled by the electrical activities produced by the ear muscles contractions that will be captured by surface electromyography (EMG) signals.
The computer game performance of each participant before and after the second step of training with surface EMG signals feedback and the mean surface EMG signal amplitude of the auricular muscles at the maximum voluntary contraction at baseline, after the first step of training, and after the second step of training will be compared.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peri-auricular muscles voluntary contraction training paradigm | Experimental | Device: FastStart neuromuscular electrical stimulatorThe whole training paradigm consists of two steps. At the first step of training, the electrical stimulation (FastStart neuromuscular electrical stimulator) will be applied to facilitate the voluntary contractions of the ear muscles, and the motion of the outer ear in two directions (up/down, forward/backward) will be videotaped and played back to the participants so that they can get real-time visual feedback about their ear movement. At the second step of training, surface EMG electrodes will be placed on the skin around participants' ears. During the training, they are required to move a cursor to a specific target that will randomly appear on the computer screen. The cursor will be controlled by the electrical signal from the contraction of their bilateral peri-auricular muscles. In the computer game, contraction of the left ear muscles will move the cursor to the left side and contraction of your right ear muscles will move the cursor to the right side. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy participants
- can't control their peri-auricular muscles at the beginning of the study (no visible movement of the ears on command).
Key exclusion criteria (7 listed)
- Suffering any comorbid neuromuscular disease.
- Having a history of severe traumatic brain injury.
- Demonstrating cognitive impairment that would prevent them from providing inform consent or following the directions of the study protocol.
- Having a history of migraine headaches that could be exacerbated with the use of the electrical stimulation or the prolonged training sessions.
- Temporomandibular Joint (TMJ) dysfunction that could lead to unusual discomfort following training session.
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 |
|---|---|---|
| FastStart neuromuscular electrical stimulatorAlso: Biosemi Active two EMG measurement system | Device | Peri-auricular muscles voluntary contraction training paradigm |
Primary outcome
The surface EMG signal amplitude of the auricular muscles at the maximum voluntary contraction
Time frame: Up to 5 weeks
1 secondary outcome
The computer game performance score
Time frame: Up to 2 weeks
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 5 Apr 2017.
- Derived from this study: PubMed 31200729Chanthaphun S, Heck SL, Winstein CJ, Baker L. Development of a training paradigm for voluntary control of the peri-auricular muscles: a feasibility study. J Neuroeng Rehabil. 2019 Jun 14;16(1):75. doi: 10.1186/s12984-019-0540-x.
- Individual participant dataSharing planned: Undecided
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.
Carolee J. Winstein, Ph.D principal investigator
University of Southern California
Baker Lucinda, Ph.D principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing FastStart neuromuscular electrical stimulator in people with Non-disabled Volunteers and Lacking Voluntary Control of Ear Muscles, run by University of Southern California 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 2 inclusion and 7 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 5 Apr 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The surface EMG signal amplitude of the auricular muscles at the maximum voluntary contraction (time frame: Up to 5 weeks). 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 NCT02358915, which also lists 1 linked publication.
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 5 Apr 2017.