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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
Sponsored by
Chalmers University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
May 18, 2021
Last Updated
March 8, 2022
Sponsor
Chalmers University of Technology
Collaborators
Sahlgrenska University Hospital, Sweden
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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.
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
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
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
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.
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
No
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
Email
maxo@chalmers.se
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Pettersen
Email
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
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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
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Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

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