Back to resultsStudying Electromyographic Activity in Patients With Upper Limb Amputations
Primary Purpose
Amputation, Traumatic
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fine wire EMG electrodes
Sponsored by
About this trial
This is an interventional basic science trial for Amputation, Traumatic
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Neuroma Graft
Prosthetic Control Graft
Able Bodied
Arm Description
In this arm, participants have already had partial muscle grafts placed on the amputated nerves to control neuroma growth. The investigators will place small electrodes percutaneously into the muscle grafts to record EMG signals and electrically stimulate the implanted nerves.
In this arm, participants will have an initial surgery to place partial muscle grafts on the amputated nerves. After a healing period, the investigators will place small electrodes percutaneously into the muscle grafts to record EMG signals and electrically stimulate the implanted nerves.
The investigators will place small electrodes percutaneously into intact muscles in the arm to record EMG signals and electrically stimulate the intact nerves nearby.
Outcomes
Primary Outcome Measures
Amplitude of EMG signal
Number of separate sensory percepts evoked
Secondary Outcome Measures
Full Information
NCT ID
NCT02956603
First Posted
November 2, 2016
Last Updated
January 11, 2023
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT02956603
Brief Title
Studying Electromyographic Activity in Patients With Upper Limb Amputations
Official Title
Studying Electromyographic Activity in Patients With Upper Limb Amputations
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation, Traumatic
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neuroma Graft
Arm Type
Experimental
Arm Description
In this arm, participants have already had partial muscle grafts placed on the amputated nerves to control neuroma growth. The investigators will place small electrodes percutaneously into the muscle grafts to record EMG signals and electrically stimulate the implanted nerves.
Arm Title
Prosthetic Control Graft
Arm Type
Experimental
Arm Description
In this arm, participants will have an initial surgery to place partial muscle grafts on the amputated nerves. After a healing period, the investigators will place small electrodes percutaneously into the muscle grafts to record EMG signals and electrically stimulate the implanted nerves.
Arm Title
Able Bodied
Arm Type
Experimental
Arm Description
The investigators will place small electrodes percutaneously into intact muscles in the arm to record EMG signals and electrically stimulate the intact nerves nearby.
Intervention Type
Other
Intervention Name(s)
Fine wire EMG electrodes
Intervention Description
Electrodes placed either in partial muscle grafts or in intact muscle to record and stimulate
Primary Outcome Measure Information:
Title
Amplitude of EMG signal
Time Frame
<4 hours
Title
Number of separate sensory percepts evoked
Time Frame
<4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared
Learn more about this trial
Studying Electromyographic Activity in Patients With Upper Limb Amputations
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