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Neuropathic PainNCT04897425

Mindful SensoriMotor Therapy With Brain Modulation in Highly Impaired Extremities

A study testing Mindful SensoriMotor Therapy Enhanced with Brain Modulation in people with Neuropathic Pain and Phantom Limb Pain, run by Chalmers University of Technology at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuropathic Pain, Phantom Limb Pain
What is being tested?
Mindful SensoriMotor Therapy Enhanced with Brain Modulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteSweden
Study dates
1 Jun 2022to 1 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Max Ortiz Catalan, PhD contact

+46708461065

maxo@chalmers.se

Emily Pettersen contact

emily.pettersen@vgregion.se

Sweden1 site

  • Center for Bionics and Pain Research, CBPR

    Mölndal, Västra Götaland County, 431 80

    Max Ortiz Catalan, PhD

    Max Ortiz Catalan, PhD

Other trials in Sweden

About this study

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

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).

Read the 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.

Being tested
Mindful SensoriMotor Therapy Enhanced with Brain Modulation
Keywords
Guided Plasticity therapy, Phantom Motor Execution, Mindful SensoriMotor Therapy, Brain Modulation, transcranial Direct Current Stimulation (tDCS), Neurological disorders, Neurobehavioral Manifestations
Medical subject headings
Neuralgia, Phantom Limb, Nervous System Diseases, Neurobehavioral Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindful SensoriMotor Therapy Enhanced with Brain ModulationDevice

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

    tES by Neuroelectrics

Study groups in NCT04897425
Study groupRoleWhat they receive
Mindful SensoriMotor Therapy Enhanced with Brain ModulationExperimentalThe 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.
Receives: Device: Mindful SensoriMotor Therapy Enhanced with Brain Modulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2021
  2. Study start1 Jun 2022 (estimated)
  3. Primary completion1 Aug 2023 (estimated)
  4. Study completion1 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm clinical trial
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04897425
Sponsor's protocol ID
2020-07147
Status last verified
Mar 2022
First submitted
18 May 2021
Last updated
9 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The study protocol article will be published in a scientific journal.

Publications

  • 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.

    PubMed 27916234

  • 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.

    PubMed 30012784

  • 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.

    PubMed 30237784

  • 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.

    PubMed 36627156

Questions about this trial

What is this clinical trial studying?

A study testing Mindful SensoriMotor Therapy Enhanced with Brain Modulation in people with Neuropathic Pain and Phantom Limb Pain, run by Chalmers University of Technology at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Max Ortiz Catalan, PhD (+46708461065, maxo@chalmers.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in Pain Rating Index (PRI) over the treatment duration (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.]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04897425, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.

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