Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

Chalmers University of Technology

Status: Unknown

Conditions: Neuropathic Pain; Phantom Limb Pain

Treatments: Device: Mindful SensoriMotor Therapy Enhanced with Brain Modulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04897425

2020-07147

Details and patient eligibility

About

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).

Full 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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Mindful SensoriMotor Therapy Enhanced with Brain Modulation

Experimental group

Description:

The participant can choose between one, two, or five interventions per week depending on their availability. Steps of each intervention: 1. Pain Evaluation: Numeric Rating Scale (NRS) 2. Functional Assessments (1st, 5th, 10th, and last sessions) 3. Preparation: 1. Locate participant in a comfortable position for training (comfortable chair, about a meter distance to the screen, pleasant arm position) 2. Placement of the surface electrodes 3. Positioning of the feedback wearable device over the affected body part 4. Placement of the brain modulation cap 4. Treatment modalities: 1. Motor training 2. Sensory training 3. Sensorimotor training 5. 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.

Treatment:

Device: Mindful SensoriMotor Therapy Enhanced with Brain Modulation