Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

Sponsor

Chalmers University of Technology (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04897425

Collaborator

Sahlgrenska University Hospital, Sweden (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Neuropathic Pain Phantom Limb Pain	Device: Mindful SensoriMotor Therapy Enhanced with Brain Modulation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single arm clinical trialSingle arm clinical trial

Masking:

None (Open Label)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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: 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 Hardware and software for myoelectric pattern recognition and sensory training developed at the Center for Bionics and Pain Research. tES by Neuroelectrics

Arm

Intervention/Treatment

Experimental: 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: 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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.