Phantom Motor Execution Via MPR, VR/AR, and SG, as a Treatment of PLP (NCT03112928) | Clinical Trial Compass
CompletedNot Applicable
Phantom Motor Execution Via MPR, VR/AR, and SG, as a Treatment of PLP
United States, Canada, Germany77 participantsStarted 2017-05-08
Plain-language summary
This international, multi-center, double-blind, randomized, controlled clinical trial aims to evaluate the efficacy of Phantom Motor Execution (PME) and Phantom Motor Imagery (PMI) as treatments of Phantom Limb Pain (PLP). In PME, myoelectric pattern recognition (MPR) is used to predict motor volition and then use the decoded movements to control virtual and augmented reality environments (VR/AR), along with serious gaming (SG). The same device and VR/AR environments are used in PMI with the difference that subjects will imagine rather than execute phantom movements. Electromyography is used to monitor for no muscular activity in PMI.
Who can participate
Age range
18 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.
* Subject must be older than 18 years.
* If the subjects are under pharmacological treatments, there must be no variations on the medicament dosages for at least one month (steady consumption).
* The last session of previous treatments must be at least 3 months old.
* Any pain reduction potentially attributed to previous phantom limb pain treatments must be at least 3 months old.
* Subjects must have control over at least a portion of biceps and triceps muscles for upper limb amputations, and quadriceps and hamstrings for the lower limb amputations.
* The subject has signed a written informed consent.
* The subject must be in a stable prosthetic situation (i.e. satisfied with the fitting of the prosthesis) or being a non user.
* At least six months should be passed since the amputation: acute phantom limb pain cases should not be included in the study.
* The patient subject should not have a significant cognitive impairment that prevents the patient from following instructions.
* Subjects with abundant soft tissue on their stump will not be automatically excluded, however, an evaluation in the system is required to analyze if sufficient electromyography signals can be recorded.
* Subjects for whom skin contact or muscle contraction are painful (NRS \> 2) are not eligible for the study.
* The subject should not have any condition associated with risk of poor protocol compliance.
* The subject should not have any other condition or symptoms preventing the patient from entering …
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
Pain Rating Index registered at the beginning (1st session) and at the end of the treatment (15th session).
Timeframe: 28-40 weeks, depending on the frequency of the sessions.