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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02956603
Other study ID # HUM00088547
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 2014
Est. completion date November 2023

Study information

Verified date January 2023
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Fine wire EMG electrodes
Electrodes placed either in partial muscle grafts or in intact muscle to record and stimulate

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Outcome

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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