Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

NCT04897425 | Unknown

• 1 other identifier: 2020-07147
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (1)

• 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.]

Study Arms (1)

Mindful SensoriMotor Therapy Enhanced with Brain Modulation

EXPERIMENTAL

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.

Device: Mindful SensoriMotor Therapy Enhanced with Brain Modulation

Interventions

Mindful SensoriMotor Therapy Enhanced with Brain Modulation DEVICE

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

Mindful SensoriMotor Therapy Enhanced with Brain Modulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Chalmers University of Technology: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Center for Bionics and Pain Research, CBPR

Mölndal, Västra Götaland County, 431 80, Sweden

Location

Related Publications (4)

• 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.

  PMID: 27916234 BACKGROUND

• 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.

  PMID: 30012784 BACKGROUND

• 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.

  PMID: 30237784 BACKGROUND

• Damercheli S, Buist M, Ortiz-Catalan M. Mindful SensoriMotor Therapy combined with brain modulation for the treatment of pain in individuals with disarticulation or nerve injuries: a single-arm clinical trial. BMJ Open. 2023 Jan 10;13(1):e059348. doi: 10.1136/bmjopen-2021-059348.

  PMID: 36627156 DERIVED

MeSH Terms

Conditions

Neuralgia; Phantom Limb; Nervous System Diseases; Neurobehavioral Manifestations

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Pain, Postoperative; Postoperative Complications; Pathologic Processes

Study Officials

• Max Ortiz Catalan, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Max Ortiz Catalan, PhD

CONTACT

+46708461065; maxo@chalmers.se

Emily Pettersen

CONTACT

emily.pettersen@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single arm clinical trial

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: June 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol is estimated to be available from November 2021.
• Access Criteria: open access

Locations

SE (1)