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Improving Prosthetic Limb Control with Implanted Electrodes After Amputation

This study is testing a device called a bipolar percutaneous intramuscular electromyography electrode. This device is for people who have had an upper limb amputation and have also had a surgery called regenerative peripheral nerve interface (RPNI). The goal is to see if these electrodes can help improve control of advanced prosthetic arms and hands. Researchers will also look at how safe the electrodes are and how well they can record signals from the RPNI grafts. They will also see if the electrodes can deliver electrical stimulation to create sensory feelings. You might be able to join if you are 22 to 75 years old and have had an upper limb amputation. The study aims to enroll 10 participants. The study's success will be measured by changes in pain levels over time, using surveys like the SF-36, LANSS, and Phantom Limb Questionnaire. The current status of the study is unclear.

Study design
This is a single-center study involving 10 participants. It is an early feasibility study, meaning it's an initial look at the safety and effectiveness of the device.
What's involved
You would have electrodes implanted, which would remain for up to 7 years. You would also have at least two study visits per month to perform prosthesis control and sensory feedback experiments.
Compensation
Not stated in the trial record.
Follow-up
Your pain levels will be measured at the beginning of the study and monthly for up to 7 years after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03260400

Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals

Recruiting
NAAges 22–75InterventionalDevice feasibility
University of Michigan
~10 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:a bipolar percutaneous intramuscular electromyography electrode

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pain Level as measured by SF-36
Measured over Baseline and monthly for up to 10 years postoperatively
+4 more outcomes measured

Conditions

Amputation Neuroma
Amputation

Explore related trials

AmputationAmputation NeuromaRegenerative Peripheral Nerve Interface Surgery

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Paul Cederna, M.D. · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Paul Cederna, M.D.
[email protected]
734-936-5885
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must be 22 years of age or older.
Participants must have previously undergone an upper limb amputation proximal to the wrist or are scheduled to undergo an upper limb amputation proximal to the wrist.
For participants without existing RPNI grafts (at the time of enrollment), the residual limb must have sufficient soft tissue quality to support performance of the RPNI operative procedure. Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring may not be appropriate candidates for inclusion in the study.
Participants must be in good health and American Society of Anesthesiologists (ASA) Class I or II (low surgical risk).
Participants must have reliable transportation.
Participants must be able to attend at minimum 6 hours of experiments per month while electrodes remain implanted.
Participants must be at least 6 months post-amputation.
Participants who will receive an amputation at the same time as RPNI grafts and electrodes must be undergoing an elective amputation surgery where loss of useful function of the hand has occurred. They must be at least 6 months post-injury or failed limb salvage to participate.

Exclusion

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.
Participants must not be suffering from any untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to participate from their mental health professional.
Participants must not have any medical conditions that, in the opinion of the Principal Investigator, would place them at high risk for a surgical procedure including recent myocardial infarction, cerebrovascular accidents, deep venous thrombosis, pulmonary embolus, uncontrolled diabetes, or end stage renal disease.
Participants must not have used tobacco for at least one month prior to enrollment in the study.
Participants must agree to not use tobacco for the duration of the study.
Participants cannot have sustained bilateral upper extremity amputation.
Participants cannot be pregnant.
Participants must not have other indwelling electronic implants like pacemakers, implantable cardioverter defibrillators, implantable neurostimulators, body worn insulin pumps, or body worn patient monitoring devices.
Participants must not have severe peripheral vascular occlusive disease, venous hypertension of the extremity, or severe lymphedema of the extremity.
Participants must not have an autoimmune condition which is not well controlled by medication.
Participants will not be considered for enrollment in Primary Upper Limb Amputation with RPNI Grafts and Electrode Implantation if their amputation is a traumatic injury or cancer related

What this trial measures

  • Change in Pain Level as measured by SF-36Baseline and monthly for up to 10 years postoperatively

    Pain will be assessed using the SF-36 survey instrument, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. Two questions related to pain with a score closer to 0 means a pain increase

  • Change in Pain Level as measured by LANSS surveyBaseline and monthly for up to 10 years postoperatively

    Pain will be assessed using the LANSS survey instrument, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. A score greater than 12 indicates neuropathic pain.

  • Change in Pain Level as measured by Phantom Limb QuestionnaireBaseline and monthly for up to 10 years postoperatively

    Phantom pain will be assessed using the Phantom Limb Questionnaire, to be filled out by the participant before and after each surgical procedure performed and at a minimum of once per month while electrodes remain implanted. This 9-item instrument measures phantom pain on a scale of 0-4, where 0-no pain at all and 4=very severe pain.

  • RPNI tissue degeneration measured by pain scoresBaseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted.

    RPNI tissue degeneration will be assessed by changes in pain scores (see above) and measurements of recording efficacy. Recording efficacy will be assessed using two signal quality measures: 1. Peak-to-peak signal amplitude during maximum voluntary contraction 2. Signal-to-noise ratio during maximum voluntary contraction

  • RPNI electrode migration assessed by changes recording in efficacy and ultrasoundBaseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted.

    Electrode migration outside of the implanted RPNI graft or muscle will be assessed by changes in recording efficacy, as described above, and by ultrasound examination as necessary. Electrode extrusion and implantation complications will be assessed by adverse events reported by both the participant and the study physicians. At each study visit, the participant will be asked to report any issues, and will have a basic examination of the affected limb performed by study physicians and/or trained staff.