Studying Electromyographic Activity in Patients With Upper Limb Amputations

Amputation, Traumatic Clinical Trial

Official title:

Studying Electromyographic Activity in Patients With Upper Limb Amputations

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02956603
• Other study ID #: HUM00088547
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Amputation, Traumatic

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