Identifying Body Awareness-related Brain Network Changes During Cognitive Multisensory Rehabilitation for Reduced Neuropathic Pain in People With Spinal Cord Injury
NCT ID: NCT04706208
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2020-09-01
2024-02-29
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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One time testing - able-bodied healthy adults
Participants 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.
Clinical Assessment
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)
The MRI scanning will include structural scans, resting-state functional MRI, and 4 task-based functional MRI.
OPTIONAL: blood draw
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.
Usual Care, then Cognitive Multisensory Therapy - adults with spinal cord injury + neuropathic pain.
This 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
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 Care
Standard of care treatment for neuropathic pain after spinal cord injury
Clinical Assessment
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)
The MRI scanning will include structural scans, resting-state functional MRI, and 4 task-based functional MRI.
OPTIONAL: blood draw
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.
Cognitive Multisensory Therapy, then Usual Care - adults with spinal cord injury + neuropathic pain.
This 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.
Cognitive Multisensory Therapy
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 Care
Standard of care treatment for neuropathic pain after spinal cord injury
Clinical Assessment
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)
The MRI scanning will include structural scans, resting-state functional MRI, and 4 task-based functional MRI.
OPTIONAL: blood draw
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.
Interventions
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Cognitive Multisensory Therapy
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 Care
Standard of care treatment for neuropathic pain after spinal cord injury
Clinical Assessment
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)
The MRI scanning will include structural scans, resting-state functional MRI, and 4 task-based functional MRI.
OPTIONAL: blood draw
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
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
70 Years
ALL
Yes
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Ann Van de Winckel, Van de Winckel
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of MInnesota (Brain Body Mind Lab, Division of Physical Therapy, Department of Rehab Med, Medical School)
Minneapolis, Minnesota, United States
Countries
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References
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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.
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.
Related Links
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Brain Body Mind Lab website link for the AIRP study
Other Identifiers
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PMR-2020-29297
Identifier Type: -
Identifier Source: org_study_id
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