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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and monthly for up to 7 years postoperatively
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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It has been over 6 months since my amputation.
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I am 22 years old or older.
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I have had an amputation above my wrist.
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My limb has enough healthy tissue for surgery and wasn't severely damaged by crushing or tearing.
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I am in good health and considered low risk for surgery.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
1,786 Previous Clinical Trials
6,365,112 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,337 Previous Clinical Trials
648,834 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for individuals to partake in this trial?

"Clinicaltrials.gov confirms that this research is actively recruiting participants; The trial was initially posted on July 19th, 2017 and has since undergone a modification as recently as May 26th 2022."

Answered by AI

Who can be accepted into this research endeavor?

"The current clinical trial necessitates that participants possess an amputation and are between 22 and 65 years old. They aim to recruit 10 individuals for the study."

Answered by AI

To what extent is enrollment being sought for this experiment?

"Yes, the data found on clinicaltrials.gov indicates that this trial is currently seeking participants. The study was initiated on July 19th 2017 and last modified May 26th 2022, requiring 10 individuals from a single site to take part in the experiment."

Answered by AI

Does the trial accept volunteers over 50 years of age?

"This research opportunity is open to individuals who are aged between 22 and 65."

Answered by AI
~3 spots leftby May 2027