Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

Not Applicable

• Conditions: Neuropathic Pain; Phantom Limb Pain

• Registration Number: NCT04897425
• Lead Sponsor: Chalmers University of Technology

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, 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).

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 intervention. Each participant attends a screening visit, up to 5 baseline assessments, 15 interventions, and 3 follow-ups at 1, 3, and 6 months after the last intervention. Brain imaging will be performed pre- and post-treatment.

Study Timeline

• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-21
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09
• Study Start: 2022-06-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The change in Pain Rating Index (PRI) over the treatment duration	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.]	The Pain Rating Index (PRI) is calculated as the sum of 15 descriptors presented to the participant at the end of each intervention session. Descriptors are rated from 0 (no pain) to 3 (maximum pain) and therefore, the PRI is a number between 0 and 45. The higher PRI number, the greater pain the person feels

Secondary Outcome Measures

Name	Time	Method
The change in Pain Disability Index (PDI) between the first and the last treatment session.	PDI assessed at the beginning the end of the treatment. [ Time Frame: 28-40 weeks, depending on the frequency of the sessions.]	The Pain Disability Index (PDI) measures the impact of the pain on the ability of a person to participate in essential life activities. The PDI is the sum of 7 categories and each of the category rates between 0 and 10. Therefore, the index is comprised between 0 and 70. The higher the index the greater the person's disability due to pain is.

Trial Locations

Locations (1)

Center for Bionics and Pain Research, CBPR; 🇸🇪 Mölndal, Västra Götaland, Sweden