CompletedNot Applicable

Studying Electromyographic Activity in Patients With Upper Limb Amputations

18 participantsStarted 2015-09-06

Plain-language summary

The primary purpose of this study is to determine the extent to which the Regenerative Peripheral Nerve Interface ( i.e. reinnervation of partial muscle grafts by residual peripheral nerves) enables both the generation of high-performance motor control signals for prosthetic limbs, and the input of sensory percepts by electrical stimulation.

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: * For the prosthetic control graft arm: * Must have previously undergone upper limb amputation * Must be otherwise healthy (e.g. no severe pain syndromes or untreated mental health disorders) * Must be American Society of Anesthesiologists (ASA) Class I (low surgical risk) * Must have sufficient soft tissue quality to support performance of the operative procedures * Must have NOT previously received the partial muscle graft surgery * For the neuroma graft arm: * Must have previously undergone upper limb amputation * Must be otherwise healthy (e.g. no severe pain syndromes or untreated mental health disorders) * Must have previously received the partial muscle graft surgery * For the able-bodied arm: * Must have NOT undergone upper limb amputation * Must be in good health Exclusion criteria: * For the prosthetic control graft arm: * Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring, may not be appropriate candidates for inclusion in the study * For the able-bodied arm: * Participants with a history of nerve pain may not be appropriate candidates for inclusion in the study

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

Amplitude of EMG signal

Timeframe: <4 hours

Number of separate sensory percepts evoked

Timeframe: <4 hours

Trial details

NCT IDNCT02956603

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-12

View on ClinicalTrials.gov More Amputation, Traumatic trials