Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities (NCT04897425) | Clinical Trial Compass
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Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities
Sweden8 participantsStarted 2022-06-01
Plain-language summary
Brief summary: This single-arm, pilot clinical investigation aims to evaluate Mindful SensoriMotor Therapy (MSMT) enhanced with brain modulation as a treatment of pain due to sensorimotor impairment, such as Phantom Limb Pain (PLP). MSMT consists of consciously retraining the motor and sensory networks used by the missing limb via myoelectric pattern recognition and haptic feedback. In this trial, we further enhance the effect of MSMT by brain modulation, transcranial Direct Current Stimulation (tDCS).
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.
Inclusion criteria
* The participant has given written informed consent to participate.
* The participant must have chronic neuropathic pain due to sensorimotor impairment (example PLP).
* At least six months should be passed since the date of injury (acute pain cases should not be included in the study).
* If the participant is under pharmacological treatments, there must be no variations on the medication dosages (steady consumption) for at least 1 month before the screening visit.
* If the participant has previously been treated for neuropathic pain, the last session of that treatment(s) must be at least 3 months before the screening visit.
* Any pain reduction potentially correlated to previous neuropathic pain treatments must have been observed at least 3 months prior to the screening visit, as reported by the participant.
* In the case of having a prosthesis, the participant must be in a stable prosthetic situation (i.e. satisfied with the fitting of the prosthesis or not using a prosthesis).
* Participants must have enough contact surface at the site of the amputation or the injured nerves for the system to work, in the researcher's opinion.
* Participants must be able to perceive the haptic stimulation at the time of the screening visit.
* Participants must not experience painful sensations from haptic stimulation in the stump (i.e. allodynia).
* The participant has a sufficient understanding of both Swedish and English to be able to participate in all study assessme…
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
The change in Pain Rating Index (PRI) over the treatment duration
Timeframe: Pain Rating Index registered at the beginning and at the end of the treatment. [ Time Frame: 28-40 weeks, depending on the frequency of the sessions.]