Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-08-01

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).

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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.

Conditions

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Neuropathic Pain Phantom Limb Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

However, the person treating the subject is different than the person evaluating the outcomes. This is done to reduce the influence that the care provider might have on the patient reporting positive outcomes.

Study Groups

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Mindful SensoriMotor Therapy Enhanced with Brain Modulation

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.

Group Type EXPERIMENTAL

Mindful SensoriMotor Therapy Enhanced with Brain Modulation

Intervention Type DEVICE

Hardware and software for myoelectric pattern recognition and sensory training developed at the Center for Bionics and Pain Research.

tES by Neuroelectrics

Interventions

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Mindful SensoriMotor Therapy Enhanced with Brain Modulation

Hardware and software for myoelectric pattern recognition and sensory training developed at the Center for Bionics and Pain Research.

tES by Neuroelectrics

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No