Studying Electromyographic Activity in Patients With Upper Limb Amputations

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02956603

Enrollment

Registered

2016-11-07

Start date

2015-09-06

Completion date

2020-11-12

Last updated

2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation, Traumatic

Brief 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.

Interventions

OTHERFine wire EMG electrodes

Electrodes placed either in partial muscle grafts or in intact muscle to record and stimulate

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Amplitude of EMG signal	<4 hours
Number of separate sensory percepts evoked	<4 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026