← Back to Search

New Electrode for Prosthetic Limb Control in Amputees

N/A
Recruiting
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be at least 6 months post-amputation
Participants must be 22 years of age or older
Must not have
Participants cannot have sustained bilateral upper extremity amputation
Participants may not be suffering from any severe pain syndrome including complex regional pain syndrome or severe phantom pain. All of these conditions would suggest pathological activity of the nerve and would exclude the participant from participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and monthly for up to 7 years postoperatively
Awards & highlights

Summary

This trial is testing a new electrode that may help people with upper-limb amputations use advanced prosthetic arms and hands.

Who is the study for?
This trial is for adults over 22 with an upper-limb amputation who are in good health and low surgical risk. They must have reliable transport, attend at least two visits per month, not use tobacco, and cannot be pregnant or have severe mental health issues without approval.
What is being tested?
The study tests a bipolar intramuscular electromyography electrode in patients with upper-limb amputations post nerve surgery to improve control of advanced prosthetic arms and hands.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, infection risks associated with surgery, possible interference with other electronic devices within the body if present.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
It has been over 6 months since my amputation.
Select...
I am 22 years old or older.
Select...
I have had an amputation above my wrist.
Select...
My limb has enough healthy tissue for surgery and wasn't severely damaged by crushing or tearing.
Select...
I am in good health and considered low risk for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have both of my arms amputated.
Select...
I do not have severe pain syndromes like complex regional pain syndrome.
Select...
I do not have severe blood vessel blockages or extreme swelling in my limbs.
Select...
My amputation was not due to an injury or cancer.
Select...
My autoimmune condition is well controlled with medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and monthly for up to 7 years postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and monthly for up to 7 years postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Pain Level as measured by LANSS survey
Change in Pain Level as measured by Phantom Limb Questionnaire
Change in Pain Level as measured by SF-36
+2 more
Secondary study objectives
EMG signal quality from RPNI grafts
Stimulation Threshold of RPNI grafts

Trial Design

2Treatment groups
Experimental Treatment
Group I: New GraftsExperimental Treatment1 Intervention
In this arm, participants will have an initial surgery to place partial muscle grafts on the amputated nerves. After a healing period, the participant will have a shorter surgical procedure to implant the electrodes onto the muscle grafts and in residual muscles. After another healing period, experiments with prosthetic control and sensory feedback will begin.
Group II: Existing GraftsExperimental Treatment1 Intervention
In this arm, participants have already had partial muscle grafts placed on the amputated nerves to control neuroma growth. The participant will have a short surgical procedure to implant the electrodes onto the muscle grafts and in residual muscles. After a healing period, experiments with prosthetic control and sensory feedback will begin.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,833 Previous Clinical Trials
6,423,118 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,362 Previous Clinical Trials
650,740 Total Patients Enrolled

Media Library

a bipolar percutaneous intramuscular electromyography electrode Clinical Trial Eligibility Overview. Trial Name: NCT03260400 — N/A
Amputation Research Study Groups: New Grafts, Existing Grafts
Amputation Clinical Trial 2023: a bipolar percutaneous intramuscular electromyography electrode Highlights & Side Effects. Trial Name: NCT03260400 — N/A
a bipolar percutaneous intramuscular electromyography electrode 2023 Treatment Timeline for Medical Study. Trial Name: NCT03260400 — N/A
~4 spots leftby May 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top