AmputationEarly Phase 1PSICON-BNCT04692571
EMG-Based Hand-Wrist Control: Study B Mirrored
A Early Phase 1 study testing PSICON Measurement Apparatus in people with Amputation and Amputation; Traumatic, Hand, run by Liberating Technologies, Inc. at 2 sites in United States.
Trial summary
Study assessing four-channel prosthesis controller, that compares contralateral (mirrored) EMG-force training to ipsilateral EMG-target training with both limb-absent and able-bodied subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amputation, Amputation; Traumatic, Hand, Amputation, Congenital
- What is being tested?
- PSICON Measurement Apparatus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jun 2017to 24 Aug 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Limb-absent subjects: unilateral trans-radial limb absence or amputation
- Be capable of completing the requested contractions on the affected dominant side
Who cannot join
- Past injuries to the upper limbs that would limit their ability to complete the requested contractions
- Scars that would impede the use of surface electrodes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Liberating Technologies, Inc
Holliston, Massachusetts, 01746
Worcester Polytechnic Institute
Worcester, Massachusetts, 01609
About this study
Official title: EMG-Based Hand-Wrist Control: Study B: Comparison of Contralateral (Mirrored) EMG-
Study assessing four-channel prosthesis controller, that compares contralateral (mirrored) EMG-force training to ipsilateral EMG-target training with both limb-absent and able-bodied subjects
Read the detailed description
System identification models relating forearm electromyogram (EMG) signals to phantom wrist radial-ulnar deviation force, pronation-supination moment and/or hand open-close force (EMG-force) are hampered by lack of supervised force/moment output signals in limb-absent subjects. In able-bodied and unilateral transradial limb-absent subjects, we studied three alternative supervised output sources in one degree of freedom (DoF) and 2-DoF target tracking tasks: (1) bilateral tracking with force feedback from the contralateral side (non-dominant for able-bodied/ sound for limb-absent subjects) with the contralateral force as the output, (2) bilateral tracking with force feedback from the contralateral side with the target as the output, and (3) dominant/limb-absent side unilateral target tracking without feedback and the target used as the output.
- Being tested
- PSICON Measurement Apparatus
- Keywords
- prosthesis, electromyography, EMG, sEMG, control, myo, regression, transradial, terminal device, electrodes
- Medical subject headings
- Amputation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSICON Measurement ApparatusDevice
Also called load cell, electrode array
Test apparatus acquires 16 sEMG channels, measure four DoFs of force/moment at the hand-wrist [hand open-close (Opn-Cls); wrist extension-flexion (Ext-Flx), radial-ulnar deviation (Rad-Uln) and pronation-supination (Pro-Sup)]. sEMG system used 16 custom encased bipolar electrodes. A commercial LTI EMG amplifier (BE328) conditioned each EMG signal before A/D conversion on a PC. A thermoplastic hand cuff secured the wrist to a six-axis load cell (AMTI, model MC3A-100) for force/moment measurement. A separate hand-grasp one-axis load cell (Omega Engineering Inc., model LCR-150) was Velcro-secured between the fingers and the thumb, to measure power grip forces. The PC acquired and stored the sEMG and load cell data, and commanded a triangular screen target. The subject controlled a second triangular cursor. Left-right movement of the cursor was controlled by wrist Ext-Flx, up-down movement by Rad-Uln deviation, cursor rotation by Pro-Sup and cursor size by hand Opn-Cls forces.
| Study group | Role | What they receive |
|---|---|---|
| Study B: Limb-Absent Subject | Experimental | Ten unilateral transradial limb-absent subjects will each participate in one, half-day experimental session. Subjects will be seated and prepared in test apparatus seat (16 electrodes on the affected side, hand-wrist on the able side secured to load cells). Subjects will complete the 1-DoF and 2-DoF "dynamic" (force-varying) contractions (40-s duration, 0.75 Hz bandlimited, uniform random target). With 2 DoF contraction trials, hand Opn-Cls will always be one of the dimensions. The subject will then be released from the cuff and their able side not further involved in the experiment. The force feedback triangle cursor on the computer screen will be deleted such that only the target remains. Subjects will then repeat 1-DoF and 2-DoF trials in which the affected side attempts to produce hand-wrist effort that mimic movement of the target (with no feedback provided). Receives: Device: PSICON Measurement Apparatus |
| Study B: Able-bodied Subjects | Experimental | Ten able-bodied subjects, the electrodes will be mounted on the dominant arm for the EMG-force and EMG-target tracking trials. In addition, the non-dominant arm will also be constrained and measured in a second load cell. This load cell will not be used for feedback during the experiment, but will compare (RMS error, off-line) the dominant vs. non-dominant forces. For EMG-target tracking, the dominant hand will remain in the wrist cuff (to prevent flailing during contractions), with the screen feedback disabled. These subjects will repeat the trials with the electrodes moved to the non-dominant side. EMG-force tracking will be repeated using mirrored contractions. The three training methods (EMG-force ipsilateral, EMG-force contralateral mirrored, EMG-target on the dominant side) will be contrasted to help understand the source of errors when training with limb-absent subjects. Receives: Device: PSICON Measurement Apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG-Force Models
Electromyogram waveform measurements (signal amplitude, frequency) will be related to force measurements (magnitude and moment) as related to the target tracking tasks. These signal-force data will be use to generate the models.
The specific outcome for each subject will be the RMS error measured in the tracking tasks as the difference between the generated control signal from the user versus the prompted target signal, as measured by an EMG array.
Measured: 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start29 Jun 2017
- Primary completion24 Aug 2020
- Study completion24 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Transradial limb-absent vs able-bodied subjects tested in sequence.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liberating Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worcester Polytechnic Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692571
- Sponsor's protocol ID
- 124039
- Other IDs
- IRB-17-155, 5R42HD076519-03
- Acronym
- PSICON-B
- Status last verified
- Dec 2020
- First submitted
- 28 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMG-Based Hand-Wrist Control: Study B: Comparison of Contralateral (Mirrored) EMG-
- ClinicalTrials.gov ID
- NCT04692571
- Acronym / sponsor ID
- PSICON-B / 124039
- Keywords
- prosthesis, electromyography, EMG, sEMG, control, myo, regression, transradial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Liberating Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Worcester Polytechnic Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 5 Jan 2021 (actual)
- 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.
Study assessing four-channel prosthesis controller, that compares contralateral (mirrored) EMG-force training to ipsilateral EMG-target training with both limb-absent and able-bodied subjects
Detailed description
System identification models relating forearm electromyogram (EMG) signals to phantom wrist radial-ulnar deviation force, pronation-supination moment and/or hand open-close force (EMG-force) are hampered by lack of supervised force/moment output signals in limb-absent subjects. In able-bodied and unilateral transradial limb-absent subjects, we studied three alternative supervised output sources in one degree of freedom (DoF) and 2-DoF target tracking tasks: (1) bilateral tracking with force feedback from the contralateral side (non-dominant for able-bodied/ sound for limb-absent subjects) with the contralateral force as the output, (2) bilateral tracking with force feedback from the contralateral side with the target as the output, and (3) dominant/limb-absent side unilateral target tracking without feedback and the target used as the output.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Transradial limb-absent vs able-bodied subjects tested in sequence.
| Arm | Type | Receives |
|---|---|---|
| Study B: Limb-Absent Subject | Experimental | Device: PSICON Measurement ApparatusTen unilateral transradial limb-absent subjects will each participate in one, half-day experimental session. Subjects will be seated and prepared in test apparatus seat (16 electrodes on the affected side, hand-wrist on the able side secured to load cells). Subjects will complete the 1-DoF and 2-DoF "dynamic" (force-varying) contractions (40-s duration, 0.75 Hz bandlimited, uniform random target). With 2 DoF contraction trials, hand Opn-Cls will always be one of the dimensions. The subject will then be released from the cuff and their able side not further involved in the experiment. The force feedback triangle cursor on the computer screen will be deleted such that only the target remains. Subjects will then repeat 1-DoF and 2-DoF trials in which the affected side attempts to produce hand-wrist effort that mimic movement of the target (with no feedback provided). |
| Study B: Able-bodied Subjects | Experimental | Device: PSICON Measurement ApparatusTen able-bodied subjects, the electrodes will be mounted on the dominant arm for the EMG-force and EMG-target tracking trials. In addition, the non-dominant arm will also be constrained and measured in a second load cell. This load cell will not be used for feedback during the experiment, but will compare (RMS error, off-line) the dominant vs. non-dominant forces. For EMG-target tracking, the dominant hand will remain in the wrist cuff (to prevent flailing during contractions), with the screen feedback disabled. These subjects will repeat the trials with the electrodes moved to the non-dominant side. EMG-force tracking will be repeated using mirrored contractions. The three training methods (EMG-force ipsilateral, EMG-force contralateral mirrored, EMG-target on the dominant side) will be contrasted to help understand the source of errors when training with limb-absent subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Limb-absent subjects: unilateral trans-radial limb absence or amputation
- Be capable of completing the requested contractions on the affected dominant side
Key exclusion criteria (2 listed)
- Past injuries to the upper limbs that would limit their ability to complete the requested contractions
- Scars that would impede the use of surface electrodes
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 |
|---|---|---|
| PSICON Measurement ApparatusAlso: load cell, electrode arrayTest apparatus acquires 16 sEMG channels, measure four DoFs of force/moment at the hand-wrist [hand open-close (Opn-Cls); wrist extension-flexion (Ext-Flx), radial-ulnar deviation (Rad-Uln) and pronation-supination (Pro-Sup)]. sEMG system used 16 custom encased bipolar electrodes. A commercial LTI EMG amplifier (BE328) conditioned each EMG signal before A/D conversion on a PC. A thermoplastic hand cuff secured the wrist to a six-axis load cell (AMTI, model MC3A-100) for force/moment measurement. A separate hand-grasp one-axis load cell (Omega Engineering Inc., model LCR-150) was Velcro-secured between the fingers and the thumb, to measure power grip forces. The PC acquired and stored the sEMG and load cell data, and commanded a triangular screen target. The subject controlled a second triangular cursor. Left-right movement of the cursor was controlled by wrist Ext-Flx, up-down movement by Rad-Uln deviation, cursor rotation by Pro-Sup and cursor size by hand Opn-Cls forces. | Device | Study B: Able-bodied Subjects, Study B: Limb-Absent Subject |
Primary outcome
EMG-Force Models
Time frame: 1 day visit
Electromyogram waveform measurements (signal amplitude, frequency) will be related to force measurements (magnitude and moment) as related to the target tracking tasks. These signal-force data will be use to generate the models. The specific outcome for each subject will be the RMS error measured in the tracking tasks as the difference between the generated control signal from the user versus the prompted target signal, as measured by an EMG array.
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 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 PSICON Measurement Apparatus in people with Amputation and Amputation; Traumatic, Hand, run by Liberating Technologies, Inc. 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 2 inclusion and 2 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 Jan 2021. 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.
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?
EMG-Force Models (time frame: 1 day visit). 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 5 Jan 2021.