Enhancing prosthetic hand control with sensory feedback for amputees
Proprioceptive Sensorimotor Integration With Neural Interfaces for Hand Prostheses
This study is testing if adding nerve stimulation to prosthetic hands can help amputees feel their hand's position and movement better, making it easier for them to control their prosthesis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04947462 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the functionality of prosthetic hands for upper limb amputees by integrating proprioceptive feedback through nerve stimulation. Researchers will apply Functional Electrical Stimulation (FES) to the residual nerves of participants to recreate the sensations of limb position and movement. By testing various stimulation placements, the study seeks to identify the most effective methods for providing users with a sense of their prosthesis, potentially enhancing their control and reducing phantom pain. The project involves six amputees and focuses on developing advanced controllers for prosthetic devices.
Who should consider this trial
Good fit: Ideal candidates include individuals with unilateral upper limb amputations who have viable nerve function and experience using a prosthesis.
Not a fit: Patients with bilateral upper limb amputations or those unable to communicate in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the usability and acceptance of prosthetic hands among amputees by restoring a sense of limb awareness.
How similar studies have performed: While the integration of sensory feedback in prosthetics is a developing field, this specific approach using implanted neural interfaces is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral upper limb amputation above or below the elbow with fully healed and healthy surgical sites * Viable peripheral nerve function in the residual nerves serving the limb * Volitional activity of the residual muscles in the amputated limb or actuating movement of the limb * Medically fit to undergo general anesthesia * Fitted with a prosthesis by a certified prosthetic and orthotic specialist (CPO) and at least one month of experience using a prosthesis * Willingness and availability to follow the study protocol * Willingness to undergo psychological evaluation, if recommended by study surgeons or investigators, to determine that the participant is mentally competent and capable of completing the study-related activities Exclusion Criteria: * Bilateral upper limb amputation, unless the amputation on the contralateral side only involves missing digits but does not qualify as a partial hand amputation * Inability to speak English * Medically unfit to undergo surgery * Pregnancy, or those who are of childbearing potential, unwilling to prevent pregnancy during the trial * Uncontrolled diabetes (HgbA1c\>8.0%) * History of neuropathy and/or radiculopathy in the target limb * Active infection or open sores on the residual limb * History of frequent infection or sores with unknown cause * Inability to provide informed consent or follow experimental protocols * Severe pain that would prevent the participant from completing study-related activities * Poor surgical candidate
Where this trial is running
Cleveland, Ohio
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Emily L Graczyk, PhD — Louis Stokes VA Medical Center, Cleveland, OH
- Study coordinator: Emily L Graczyk, PhD
- Email: Emily.Graczyk@va.gov
- Phone: (216) 791-3800
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.