Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Pro… (NCT03260400) | Clinical Trial Compass
RecruitingNot Applicable
Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals
United States10 participantsStarted 2017-12-11
Plain-language summary
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.
Who can participate
Age range
22 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion Criteria:
* 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 incl…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Level as measured by SF-36
Timeframe: Baseline and monthly for up to 7 years postoperatively
2
Change in Pain Level as measured by LANSS survey
Timeframe: Baseline and monthly for up to 7 years postoperatively
3
Change in Pain Level as measured by Phantom Limb Questionnaire
Timeframe: Baseline and monthly for up to 7 years postoperatively
4
RPNI tissue degeneration measured by pain scores
Timeframe: Baseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted.
5
RPNI electrode migration assessed by changes recording in efficacy and ultrasound
Timeframe: Baseline and once per month after surgery following a 3-month postoperative recovery period, while electrodes remain implanted.