Amputation, Traumatic Clinical Trial
Official title:
Studying Electromyographic Activity in Patients With Upper Limb Amputations
Verified date | January 2023 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | November 2023 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Amplitude of EMG signal | <4 hours | ||
Primary | Number of separate sensory percepts evoked | <4 hours |
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