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New treatment option for Amputation Neuroma
Official title Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals
ClinicalTrials.gov ID: NCT03260400
What this study is testing
- What it's testing
- 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.
- Time commitment: about 7 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75
You may be able to join if
- 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...
- Participants must be in good health and American Society of Anesthesiologists (ASA) Class I or II (low surgical risk).
- Participants must have reliable transportation.
You likely can't join if
- Participants may not be suffering from any severe pain syndrome including complex regional pain syndrome or severe phantom pain. All of these...
- Participants must not be suffering from any untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to...
- Participants must not have any medical conditions that, in the opinion of the Principal Investigator, would place them at high risk for a surgical...
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 7 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.