Upper Limb Amputation Below Elbow (Injury)Early Phase 1ASCENTNCT06446037
Assessment of Gesture Accuracy of a Prosthesis Control System
A Early Phase 1 study testing Non-invasive EMG band instrumentation in people with Upper Limb Amputation Below Elbow (Injury), run by Phantom Neuro Inc. at 1 site in United States.
Trial summary
The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Amputation Below Elbow (Injury)
- What is being tested?
- Non-invasive EMG band instrumentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2024to 18 Apr 2025
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals 21 years in age and older
- Individuals with amputation of one or both arms at transradial level (applies to amputees only)
- Ability to follow study directions
- Willingness and ability to sign Informed Consent
Who cannot join
- Individuals with previously diagnosed muscle pathologies
- Individuals with impaired muscle function and/or impaired ability to perform normal hand movements (normal participants) or ability to perform normal phantom hand movements (amputees)
- Individuals with transhumeral or higher amputation of both arms (applies to amputees only)
- Cognitively impaired to follow study instructions
- Allergies to skin adhesive materials necessary for cutaneous electrode placement
- Excessive hair growth on arms and inability to shave off the hair for electrode placement
Show all 9Show fewer
- Pregnant woman
- Arms or residual limbs with insufficient diameter to accommodate the wearing of two cutaneous sensor arrays
- Injuries, bruises, or open wounds on the arm that needs to be instrumented for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Phantom Neuro Inc. Operational Headquarters
Austin, Texas, 78704
About this study
Official title: Assessment of Gesture Accuracy for a Multi-electrode EMG Sensor Array Based Prosthesis Control System
The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.
Read the detailed description
The study will characterize the performance of Phantom X system and associated algorithms in decoding EMG signals for various hand gesture control. The EMG signals will be sensed using a non-invasive multi-electrode array applied to subjects' forearms.
- Being tested
- Non-invasive EMG band instrumentation
- Keywords
- Prosthesis, Upper limb amputee
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive EMG band instrumentationDevice
Also called EMG prosthesis control
The sensed EMG signals from the subjects will be decoded by Phantom X algorithm and used to drive various gestures in a desk-mounted hand prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | All subjects will be instrumented with an electrode array on their forearms. The EMG signals detected by the electrodes will be fed into Phantom X hardware running the Phantom X algorithms. The algorithms will decode the EMGs signals and drive a desk mounted hand prosthesis. Receives: Device: Non-invasive EMG band instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gesture accuracy
Percentage of hand gestures accurately decoded by Phantom X algorithm
Measured: Acute visit (at most 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start13 Aug 2024
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Amputation Below Elbow (Injury)Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phantom Neuro Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446037
- Sponsor's protocol ID
- PN01
- Acronym
- ASCENT
- Status last verified
- May 2025
- First submitted
- 28 May 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gesture Accuracy for a Multi-electrode EMG Sensor Array Based Prosthesis Control System
- ClinicalTrials.gov ID
- NCT06446037
- Acronym / sponsor ID
- ASCENT / PN01
- Keywords
- Prosthesis, Upper limb amputee
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Phantom Neuro Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 6 Jun 2024 (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.
The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.
Detailed description
The study will characterize the performance of Phantom X system and associated algorithms in decoding EMG signals for various hand gesture control. The EMG signals will be sensed using a non-invasive multi-electrode array applied to subjects' forearms.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: Non-invasive EMG band instrumentationAll subjects will be instrumented with an electrode array on their forearms. The EMG signals detected by the electrodes will be fed into Phantom X hardware running the Phantom X algorithms. The algorithms will decode the EMGs signals and drive a desk mounted hand prosthesis. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals 21 years in age and older
- Individuals with amputation of one or both arms at transradial level (applies to amputees only)
- Ability to follow study directions
- Willingness and ability to sign Informed Consent
Key exclusion criteria (9 listed)
- Individuals with previously diagnosed muscle pathologies
- Individuals with impaired muscle function and/or impaired ability to perform normal hand movements (normal participants) or ability to perform normal phantom hand movements (amputees)
- Individuals with transhumeral or higher amputation of both arms (applies to amputees only)
- Cognitively impaired to follow study instructions
- Allergies to skin adhesive materials necessary for cutaneous electrode placement
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 |
|---|---|---|
| Non-invasive EMG band instrumentationAlso: EMG prosthesis controlThe sensed EMG signals from the subjects will be decoded by Phantom X algorithm and used to drive various gestures in a desk-mounted hand prosthesis | Device | Interventional arm |
Primary outcome
Gesture accuracy
Time frame: Acute visit (at most 3 hours)
Percentage of hand gestures accurately decoded by Phantom X algorithm
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 4 Jun 2025.
- Individual participant dataSharing planned: No
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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.
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 Non-invasive EMG band instrumentation in people with Upper Limb Amputation Below Elbow (Injury), run by Phantom Neuro Inc. 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 4 inclusion and 9 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 4 Jun 2025. 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?
Gesture accuracy (time frame: Acute visit (at most 3 hours)). 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 4 Jun 2025.