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Spinal Cord InjuriesNCT04706208

Identifying Body Awareness-related Brain Network Changes During Cognitive Multisensory Rehabilitation for Reduced Neuropathic Pain in People With Spinal Cord Injury

A study testing Cognitive Multisensory Therapy, Clinical Assessment and Magnetic Resonance Imaging (MRI) in people with Spinal Cord Injuries and Neuropathic Pain, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Many adults with spinal cord injury (SCI) suffer from long-term debilitating neuropathic pain. Available treatments, including opioids, are ineffective at eliminating this pain. Based on preliminary data from Dr Morse and from Dr Van de Winckel, we have demonstrated that brain areas that are important for body… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injuries, Neuropathic Pain
What is being tested?
Cognitive Multisensory Therapy, Clinical Assessment and Magnetic Resonance Imaging (MRI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
1 Sep 2020to 29 Feb 2024
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • SCI participants:
  • SCI of ≥ 3months
  • medically stable with paraplegia (ASIA grade A-C, who can self-transfer with some assistance)
  • neuropathic pain (>3 on the numeric pain rating scale)
  • Able-bodied participants:
  • sex and age matched
  • healthy, able-bodied

Who cannot join

  • MRI contra-indications (stabilizing hardware is typically MRI safe) including seizures, cognitive impairment, or other major medical complications

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of MInnesota (Brain Body Mind Lab, Division of Physical Therapy, Department of Rehab Med, Medical School)

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Many adults with spinal cord injury (SCI) suffer from long-term debilitating neuropathic pain. Available treatments, including opioids, are ineffective at eliminating this pain. Based on preliminary data from Dr Morse and from Dr Van de Winckel, we have demonstrated that brain areas that are important for body awareness and pain perception (parietal operculum, insula) have weaker brain connectivity in adults with spinal cord injury than in able-bodied healthy adults and that Cognitive Multisensory Rehabilitation (CMR) can restore these networks. This study uses a delayed treatment arm phase I randomized controlled trial (RCT) for adults with SCI and a comparison of baseline outcomes in adults with SCI vs able-bodied healthy adults to address two aims:

AIM 1: Determine baseline differences in resting-state and task-based fMRI activation and connectivity in adults with SCI compared to able-bodied healthy controls.

AIM 2: Identify changes in brain activation and connectivity, as well as behavioral outcomes in pain and body awareness in adults with SCI after CMR versus standard of care.

Read the detailed description

One of the reasons for the current lack of effective therapies is that underlying mechanisms of neuropathic pain after SCI are not yet fully understood. Nonetheless, as suggested by numerous studies, because of the spinal injury, the inflow of sensory information is dramatically altered. Therefore, the brain is missing sensory information or receiving incorrect sensory information, which may alter the brain circuitry related to pain sensation, which in turn may drive the perception of neuropathic pain.

Cognitive multisensory rehabilitation (CMR), developed for motor recovery after stroke, has shown to be effective for treating adults with chronic pain, i.e., after shoulder impingement when compared to traditional physical therapy; or in a case study of severe phantom limb pain after below the knee amputation, resulting in such substantial pain reduction that the patient could finally be fitted with a prosthesis and walk. CMR is thought to be effective because it restores mental body representations by recalibrating sensations in combination with a focus on body awareness. Body awareness is often impaired in people with chronic pain and with dysfunctions in the sensory and motor networks, such as after SCI.

This study uses a delayed treatment arm phase I randomized controlled trial (RCT) for adults with SCI and a comparison of baseline outcomes in adults with SCI vs able-bodied healthy adults to address two aims:

AIM 1: Determine baseline differences in resting-state and task-based fMRI activation and connectivity in adults with SCI compared to able-bodied healthy controls.

AIM 2: Identify changes in brain activation and connectivity, as well as behavioral outcomes in pain and body awareness in adults with SCI after CMR versus standard of care.

More information: https://med.umn.edu/rehabmedicine/research/sci-neuropathic-pain

Being tested
Cognitive Multisensory Therapy, Usual Care, Clinical Assessment, Magnetic Resonance Imaging (MRI), OPTIONAL: blood draw
Medical subject headings
Spinal Cord Injuries, Neuralgia

What participants receive

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

  • Cognitive Multisensory TherapyBehavioural

    Cognitive multisensory rehabilitation (CMR) is a type of physical therapy that incorporates conscious perception of body positions and movements during (multi)sensory discrimination exercises. The treating therapists will give 40 minutes of discrimination exercises embedded in functional movements followed by 5 minutes of applying the learned strategies during activities of daily living. CMR uses several types of discrimination exercises: Participants discriminated shapes, length, weight, distance, resistance, textures or compare kinesthetic information with visual information for integration of multisensory information. Solving the discrimination task is combined with reflection and a learning process, prompted by the therapist on how the limb (was) moved or was positioned.

  • Usual CareOther

    Standard of care treatment for neuropathic pain after spinal cord injury

  • Clinical AssessmentBehavioural

    Clinical assessments are detailed below. Screening will include demographic and general health data; mini mental state evaluation (MMSE)-short version; Edinburgh handedness inventory; and the kinesthetic and visual imagery questionnaire (KVIQ).

  • Magnetic Resonance Imaging (MRI)Behavioural

    The MRI scanning will include structural scans, resting-state functional MRI, and 4 task-based functional MRI.

  • OPTIONAL: blood drawOther

    This part is OPTIONAL: 38ml of blood will be taken one time (for able body adults) or at 3 time points (for adults with spinal cord injury and neuropathic pain.

Study groups in NCT04706208
Study groupRoleWhat they receive
One time testing - able-bodied healthy adultsOtherParticipants in this arm will be able-bodied healthy adults who will not receive an intervention. This is just a one time testing of clinical assessments (over zoom), one MRI scan, and an optional blood draw test.
Receives: Behavioral: Clinical Assessment; Behavioral: Magnetic Resonance Imaging (MRI); Other: OPTIONAL: blood draw
Usual Care, then Cognitive Multisensory Therapy - adults with spinal cord injury + neuropathic pain.ExperimentalThis is a delayed treatment arm phase I randomized controlled trial (RCT) for participants with spinal cord injury and neuropathic pain. Participants in this arm will first receive usual care and then switch over to the experimental cognitive multisensory therapy training.
Receives: Behavioral: Cognitive Multisensory Therapy; Other: Usual Care; Behavioral: Clinical Assessment; Behavioral: Magnetic Resonance Imaging (MRI); Other: OPTIONAL: blood draw
Cognitive Multisensory Therapy, then Usual Care - adults with spinal cord injury + neuropathic pain.ExperimentalThis is a delayed treatment arm phase I randomized controlled trial (RCT) for participants with spinal cord injury and neuropathic pain. Participants in this arm will first receive the experimental cognitive multisensory therapy training and then switch over to usual care.
Receives: Behavioral: Cognitive Multisensory Therapy; Other: Usual Care; Behavioral: Clinical Assessment; Behavioral: Magnetic Resonance Imaging (MRI); Other: OPTIONAL: blood draw

What is being measured

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

  1. Pain Numeric Rating Scale (NPRS) - part of the International SCI Basic Pain Data Set

    The numeric pain rating scale assesses the highest, lowest and average pain ratings over the past week. The 1-10 numerical pain rating scale has been recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus group for use in pain clinical trials and by the 2006 National Institute on Disability and Rehabilitation Research (NIDRR) SCI Pain outcome measures consensus group. This scale is recommended to standardize pain outcomes across studies.

    Measured: weekly during the two intervention periods (each 12 weeks)

Secondary outcomes (11)

  1. Physical Activity Recall Questionnaire

    This 16 item questionnaire asks about physical activity inside of the house and away from the house (including daily physical tasks) as well as hours of sleep. Time to administer: approximately 10 minutes.

    Measured: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)

  2. Pittsburgh Sleep Quality Index (PSQI)

    This 10-item questionnaire asks about duration and quality of sleep and reasons for not sleeping well through the night. Time to administer: approximately 6 minutes.

    Measured: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)

  3. Spielberger State-Trait Anxiety Inventory

    This questionnaire asks about different moods in general (trait- 19 items) and at the moment of the testing (state- 20 items). Scoring between 1-4 reflecting "almost never" to "almost always" for trait, and "not at all" to "very much so" for state)Time to administer: approximately 5 minutes.

    Measured: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)

  4. Patient Health Questionnaire (PHQ-9)

    The PHQ-9 is a self-report questionnaire, which assesses the presence and intensity of depressive symptoms. There are 9 items scored from 0 to 3 based on the frequency of occurrence of depression symptoms in the past two weeks, 0= not at all, 1=several days, 2=more than half the days, 3= nearly every day. Total score is a sum of all items scores and should be interpreted as follows:

    5-9 Minimal Symptoms 10-14 Moderate depression 15-20 Moderately Severe depression >20 Severe depression

    And a single question rates how difficult problems have made it to do work, take care of things at home or get along with other people, using a 4-level scale ranging from not difficult at all to externally difficult.

    Total score range: 0-27

    It takes 3 minutes to finish this questionnaire.

    Measured: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)

  5. Moorong Self-Efficacy Scale (MSES)

    The Moorong Self-Efficacy Scale contains 16 items rated on a 7-point Likert scale from 1 (very uncertain) to 7 (very certain). Totals score is calculated as a sum of the 16 items scores. Total scores range from 16 to 112, with higher scores reflecting high self efficacy.

    Measured: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)

  6. WHOQOL-BREF

    The WHOQOL- BREF assesses quality of life within the context of an individual's culture, value systems, personal goals, standards and concerns in the last two weeks. This is a self-report questionnaire 26 items assessing 4 quality domains of quality of life (QOL): physical health (7 items), psychological health (6 items), social relationships (3 items) and environmental (8 items). In addition, two other items measure overall QOL and general health.

    Items are rated on a 5-point Likert scale (low score of 1 to high score of 5) to determine a raw item score. The mean score of items within each domain is used to calculate the domain score. After computed the scores, they transformed linearly to a 0-100-scale. Score of each domain is reported. A higher score indicating a higher quality of life.

    Measured: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)

  7. Revised Body Awareness Rating Questionnaire (BARQ)

    The Body Awareness Rating Questionnaire (BARQ) is a self-report questionnaire designed to capture how individuals with long-lasting musculoskeletal pain reflect on their own body awareness. This questionnaire contains 12 items rated on a scale from 0 (completely disagree) to 3 (completely agree). The total score is a sum of all items and ranges from 0 to 36, with lower scores indicating higher body awareness.

    Measured: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)

  8. Tampa Scale For Kinesiophobia

    The Tampa Scale for Kinesiophobia is a 17-item questionnaire measuring fear related to exercise and movement. Items are rated on a scale of 1 (strongly disagree) to 4 (strongly agree). A total score is calculated by summing the individual item scores after inversion of the individual scores for items 4, 8, 12 and 16. Higher scores indicated greater kinesiophobia.

    Measured: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)

  9. Physical Activity Enjoyment Scale (PACES)

    The Physical Activity Enjoyment Scale contains 18 items that are rated on a 7-point scale. 11 items are scored in reverse order. Total scores range from 18 to 126, with higher scores indicating greater level of enjoyment.

    Measured: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)

  10. Patient Specific Functional Scale

    The participants will self-identify goals related to activities in daily life that are important to them. The participants will rate them at each time point between 0 (i.e., unable to do the activity without pain) and 10 (able to do the activity without pain).This is a valid measure to assess disability in individuals with chronic pain.101 Time to administer: 5 minutes

    Measured: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)

  11. International SCI Basic Pain Data Set

    Aside from NPRS (below), The International Spinal Cord Injury Pain Data Set also assesses dimensions of pain (i.e. intensity of pain, time of day, location, occurrence, etc.), and pain interference with mood, activity, and sleep. Time to administer: 10 minutes.

    Measured: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)

Timeline

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

  1. First posted12 Jan 2021
  2. Study start1 Sep 2020
  3. Primary completion30 Nov 2023
  4. Study completion29 Feb 2024

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04706208
Sponsor's protocol ID
PMR-2020-29297
Status last verified
Sep 2024
First submitted
8 Jan 2021
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets (de-identified individual participant data and data dictionary) analyzed for this study can be found in the Dryad repository and will be made available upon publication of the article.

Publications

  • Van de Winckel A, Carpentier S, Deng W, Bottale S, Hendrickson T, Zhang L, Wudlick R, Linnman C, Battaglino R, Morse L. Identifying Body Awareness-Related Brain Network Changes After Cognitive Multisensory Rehabilitation for Neuropathic Pain Relief in Adults With Spinal Cord Injury: Protocol of a Phase I Randomized Controlled Trial. Top Spinal Cord Inj Rehabil. 2022 Fall;28(4):33-43. doi: 10.46292/sci22-00006. Epub 2022 Nov 15.

    PubMed 36457363

  • Van de Winckel A, Carpentier ST, Deng W, Bottale S, Zhang L, Hendrickson T, Linnman C, Lim KO, Mueller BA, Philippus A, Monden KR, Wudlick R, Battaglino R, Morse LR. Identifying Body Awareness-Related Brain Network Changes after Cognitive Multisensory Rehabilitation for Neuropathic Pain Relief in Adults with Spinal Cord Injury: Delayed Treatment arm Phase I Randomized Controlled Trial. medRxiv [Preprint]. 2023 Feb 10:2023.02.09.23285713. doi: 10.1101/2023.02.09.23285713.

    PubMed 36798345

  • Van de Winckel A, Carpentier ST, Deng W, Bottale S, Zhang L, Hendrickson TJ, Linnman C, Lim KO, Mueller BA, Wudlick R, Battaglino R, Morse LR. Preliminary efficacy of cognitive multisensory rehabilitation for neuropathic pain in chronic spinal cord injury: a phase I randomized controlled trial. Sci Rep. 2026 Mar 20;16(1):14330. doi: 10.1038/s41598-026-44859-w.

    PubMed 41862607

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Multisensory Therapy, Clinical Assessment and Magnetic Resonance Imaging (MRI) in people with Spinal Cord Injuries and Neuropathic Pain, run by University of Minnesota at 1 site in United States.

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 7 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Numeric Rating Scale (NPRS) - part of the International SCI Basic Pain Data Set (time frame: weekly during the two intervention periods (each 12 weeks)). 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 NCT04706208, which also lists 3 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 19 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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