Proprioceptive Sensorimotor Integration With Neural Interfaces for Hand Prostheses (NCT04947462) | Clinical Trial Compass
RecruitingNot Applicable
Proprioceptive Sensorimotor Integration With Neural Interfaces for Hand Prostheses
United States8 participantsStarted 2021-12-01
Plain-language summary
The purpose of this study is to characterize proprioceptive sensations in the missing limb of upper limb amputees using nerve stimulation, and to develop advanced controllers for moving a prosthesis. Proprioceptive sensations are the sensations that tell individuals where their hand is in space, and if it is moving. The research team uses Functional Electrical Stimulation (FES), which involves applying small electric currents to the nerves. These signals are then transferred to the brain just like the information about the individual's intact hand used to be transferred to their brain. This study will test different placements for stimulation and determine which one(s) provide the individual with proprioceptive sensations. The investigators want to know what the participants feel and if the investigators can use proprioceptive sensation to give the participants information about limb movement and position.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Po…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Magnitude of change in perceived joint position
Timeframe: This metric will be measured approximately each month for two years.