Identifying Body Awareness-related Brain Network Changes During Cognitive Multisensory Rehabilitation for Reduced Neuropathic Pain in People With Spinal Cord Injury
1 other identifier
interventional
58
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 8, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2024
CompletedSeptember 19, 2024
September 1, 2024
3.2 years
January 8, 2021
September 3, 2024
Conditions
Outcome Measures
Primary Outcomes (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.
weekly during the two intervention periods (each 12 weeks)
Secondary Outcomes (11)
Physical Activity Recall Questionnaire
baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
Pittsburgh Sleep Quality Index (PSQI)
baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
Spielberger State-Trait Anxiety Inventory
baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
Patient Health Questionnaire (PHQ-9)
baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
Moorong Self-Efficacy Scale (MSES)
baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
- +6 more secondary outcomes
Study Arms (3)
One time testing - able-bodied healthy adults
OTHERParticipants 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.
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.
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.
Interventions
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.
Standard of care treatment for neuropathic pain after spinal cord injury
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).
The MRI scanning will include structural scans, resting-state functional MRI, and 4 task-based functional MRI.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- MRI contra-indications (stabilizing hardware is typically MRI safe) including seizures, cognitive impairment, or other major medical complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of MInnesota (Brain Body Mind Lab, Division of Physical Therapy, Department of Rehab Med, Medical School)
Minneapolis, Minnesota, 55455, United States
Related Publications (2)
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.
PMID: 36457363BACKGROUNDVan 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.
PMID: 36798345BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Van de Winckel, Van de Winckel
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2021
First Posted
January 12, 2021
Study Start
September 1, 2020
Primary Completion
November 30, 2023
Study Completion
February 29, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
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.