Status:
UNKNOWN
Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities
Lead Sponsor:
Chalmers University of Technology
Collaborating Sponsors:
Sahlgrenska University Hospital
Conditions:
Neuropathic Pain
Phantom Limb Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, ...
Detailed Description
People with upper or lower limb disarticulation (amputation at joint level) or nerve injury will participate in this study. It is a single-arm study in which all participants receive the same interven...
Eligibility Criteria
Inclusion
- 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 assessments, in the researcher's opinion.
- Participants should not have any other condition or symptoms that can prevent them from participating in the study, in the researcher's opinion.
- No mental inability, reluctance, or language difficulties that result in difficulty understanding the meaning of study participation, in the researcher's opinion.
- The participant should not have any condition associated with the risk of poor protocol compliance, in the researcher's opinion.
- Exclusion criteria
- \- The potential participant will be excluded from the study if the person does not meet at least one of the inclusion criteria.
Exclusion
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04897425
Start Date
June 1 2022
End Date
August 1 2023
Last Update
March 9 2022
Active Locations (1)
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1
Center for Bionics and Pain Research, CBPR
Mölndal, Västra Götaland County, Sweden, 431 80