Evaluating a new prosthesis control system for upper limb amputees
Assessment of Gesture Accuracy for a Multi-electrode EMG Sensor Array Based Prosthesis Control System
EARLY_PHASE1 · Phantom Neuro Inc. · NCT06446037
This study is testing a new control system for prosthetic hands to see if it can help people with upper limb amputations use their prosthetics more effectively by interpreting their muscle signals.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Phantom Neuro Inc. (industry) |
| Locations | 1 site (Austin, Texas) |
| Trial ID | NCT06446037 on ClinicalTrials.gov |
What this trial studies
This study assesses the performance of the Phantom X prosthesis control system, focusing on its ability to decode electromyography (EMG) signals for hand gesture control. The research involves both able-bodied individuals and those with upper limb amputations at the forearm level. Participants will wear a non-invasive multi-electrode array on their forearms to capture EMG signals, which will be analyzed to determine the accuracy of gesture control. The goal is to enhance the functionality of prosthetic devices for amputees.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 21 and older with transradial amputations who can follow study directions and provide informed consent.
Not a fit: Patients with higher-level amputations, significant muscle pathologies, or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved control and functionality of prosthetic limbs for individuals with upper limb amputations.
How similar studies have performed: While the approach of using EMG signals for prosthetic control is established, the specific Phantom X system's performance is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Individuals 21 years in age and older 2. Individuals with amputation of one or both arms at transradial level (applies to amputees only) 3. Ability to follow study directions 4. Willingness and ability to sign Informed Consent Exclusion Criteria: 1. Individuals with previously diagnosed muscle pathologies 2. 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) 3. Individuals with transhumeral or higher amputation of both arms (applies to amputees only) 4. Cognitively impaired to follow study instructions 5. Allergies to skin adhesive materials necessary for cutaneous electrode placement 6. Excessive hair growth on arms and inability to shave off the hair for electrode placement 7. Pregnant woman 8. Arms or residual limbs with insufficient diameter to accommodate the wearing of two cutaneous sensor arrays 9. Injuries, bruises, or open wounds on the arm that needs to be instrumented for the study
Where this trial is running
Austin, Texas
- Phantom Neuro Inc. Operational Headquarters — Austin, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Vinod Sharma, PhD
- Email: vinod@phantomneuro.com
- Phone: 763-350-2091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Upper Limb Amputation Below Elbow, Prosthesis, Upper limb amputee