Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindful SensoriMotor Therapy With Brain Modulation for the Treatment of Pain in Individuals With Disarticulation or Nerve Injuries: A Single Arm Clinical Trial

Conditions
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Neuropathic Pain, Phantom Limb Pain

Intervention / Treatment
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* Device: Mindful SensoriMotor Therapy Enhanced with Brain Modulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful SensoriMotor Therapy Enhanced with Brain Modulation<br>The participant can choose between one, two, or five interventions per week depending on their availability. Steps of each intervention: Pain Evaluation: Numeric Rating Scale (NRS) Functional Assessments (1st, 5th, 10th, and last sessions) Preparation: Locate participant in a comfortable position for training (comfortable chair, about a meter distance to the screen, pleasant arm position) Placement of the surface electrodes Positioning of the feedback wearable device over the affected body part Placement of the brain modulation cap Treatment modalities: Motor training Sensory training Sensorimotor training Assessments Step 4 is repeated for different phantom movements, initially one at a time, progressing to several joints simultaneously. A treatment session lasts 2 hours. | Device: Mindful SensoriMotor Therapy Enhanced with Brain Modulation<br>* Hardware and software for myoelectric pattern recognition and sensory training developed at the Center for Bionics and Pain Research. tES by Neuroelectrics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Pain Rating Index (PRI) over the treatment duration | 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 | 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.] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Pain Disability Index (PDI) between the first and the last treatment session. | 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. | PDI assessed at the beginning the end of the treatment. [ Time Frame: 28-40 weeks, depending on the frequency of the sessions.] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guided Plasticity therapy, Phantom Motor Execution, Mindful SensoriMotor Therapy, Brain Modulation, transcranial Direct Current Stimulation (tDCS), Neurological disorders, Neurobehavioral Manifestations