Back to results

Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

Primary Purpose

Neuropathic Pain, Phantom Limb Pain

Status

Not yet recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Mindful SensoriMotor Therapy Enhanced with Brain Modulation

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Guided Plasticity therapy, Phantom Motor Execution, Mindful SensoriMotor Therapy, Brain Modulation, transcranial Direct Current Stimulation (tDCS), Neurological disorders, Neurobehavioral Manifestations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Exclusion criteria

- The potential participant will be excluded from the study if the person does not meet at least one of the inclusion criteria.

Sites / Locations

Center for Bionics and Pain Research, CBPR

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindful SensoriMotor Therapy Enhanced with Brain Modulation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04897425

First Posted

May 18, 2021

Last Updated

March 8, 2022

Sponsor

Chalmers University of Technology

Collaborators

Sahlgrenska University Hospital, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT04897425

Brief Title

Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 1, 2022 (Anticipated)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chalmers University of Technology

Collaborators

Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain, Phantom Limb Pain

Keywords

Guided Plasticity therapy, Phantom Motor Execution, Mindful SensoriMotor Therapy, Brain Modulation, transcranial Direct Current Stimulation (tDCS), Neurological disorders, Neurobehavioral Manifestations

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single 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.

Allocation

N/A

Enrollment

8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mindful SensoriMotor Therapy Enhanced with Brain Modulation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Mindful SensoriMotor Therapy Enhanced with Brain Modulation

Intervention Description

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

Primary Outcome Measure Information:

Title

The change in Pain Rating Index (PRI) over the treatment duration

Description

Time Frame

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 Measure Information:

Title

The change in Pain Disability Index (PDI) between the first and the last treatment session.

Description

Time Frame

PDI assessed at the beginning the end of the treatment. [ Time Frame: 28-40 weeks, depending on the frequency of the sessions.]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Max Ortiz Catalan, PhD

Phone

+46708461065

maxo@chalmers.se

First Name & Middle Initial & Last Name or Official Title & Degree

Emily Pettersen

emily.pettersen@vgregion.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Max Ortiz Catalan, PhD

Organizational Affiliation

Associate Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Bionics and Pain Research, CBPR

City

Mölndal

State/Province

Västra Götaland

ZIP/Postal Code

431 80

Country

Sweden

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Max Ortiz Catalan, PhD

First Name & Middle Initial & Last Name & Degree

Max Ortiz Catalan, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The study protocol article will be published in a scientific journal.

IPD Sharing Time Frame

The study protocol is estimated to be available from November 2021.

IPD Sharing Access Criteria

open access

Citations:

PubMed Identifier

27916234

Citation

Ortiz-Catalan M, Guethmundsdottir RA, Kristoffersen MB, Zepeda-Echavarria A, Caine-Winterberger K, Kulbacka-Ortiz K, Widehammar C, Eriksson K, Stockselius A, Ragno C, Pihlar Z, Burger H, Hermansson L. Phantom motor execution facilitated by machine learning and augmented reality as treatment for phantom limb pain: a single group, clinical trial in patients with chronic intractable phantom limb pain. Lancet. 2016 Dec 10;388(10062):2885-2894. doi: 10.1016/S0140-6736(16)31598-7. Epub 2016 Dec 2.

Results Reference

background

PubMed Identifier

30012784

Citation

Lendaro E, Hermansson L, Burger H, Van der Sluis CK, McGuire BE, Pilch M, Bunketorp-Kall L, Kulbacka-Ortiz K, Rigner I, Stockselius A, Gudmundson L, Widehammar C, Hill W, Geers S, Ortiz-Catalan M. Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial. BMJ Open. 2018 Jul 16;8(7):e021039. doi: 10.1136/bmjopen-2017-021039.

Results Reference

background

PubMed Identifier

30237784

Citation

Ortiz-Catalan M. The Stochastic Entanglement and Phantom Motor Execution Hypotheses: A Theoretical Framework for the Origin and Treatment of Phantom Limb Pain. Front Neurol. 2018 Sep 6;9:748. doi: 10.3389/fneur.2018.00748. eCollection 2018.

Results Reference

background

Learn more about this trial

Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

We'll reach out to this number within 24 hrs