RECRUITING

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

Conditions

Amputation Neuroma Amputation RPNI Regenerative Peripheral Nerve Interface

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.

Official Title

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

Quick Facts

Study Start:2017-07-19

Study Completion:2029-05-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03260400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants must be 22 years of age or older. * Participants must have previously undergone 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 2 visits per month while electrodes remain implanted. * Participants must be at least 6 months post-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. * 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

Inclusion Criteria

Exclusion Criteria

* Participants must be 22 years of age or older.
* Participants must have previously undergone 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 2 visits per month while electrodes remain implanted.
* Participants must be at least 6 months post-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.
* 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

Contacts and Locations

Study Contact

Paul Cederna, M.D.

CONTACT

734-936-5885

cederna@umich.edu

Mona Moore

CONTACT

734-998-7818

monamoor@umich.edu

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-07-19

Study Completion Date2029-05-05

Study Record Updates

Study Start Date2017-07-19

Study Completion Date2029-05-05

Terms related to this study

Keywords Provided by Researchers

RPNI
Regenerative Peripheral Nerve Interface

Additional Relevant MeSH Terms

Amputation Neuroma
Amputation