Clinical trial NCT04706208: Identifying Body Awareness-related Brain Network Changes During Cognitive Multisensory Rehabilitation for Reduced Neuropathic Pain in People With Spinal Cord Injury
Official title: Identifying Body Awareness-related Brain Network Changes During Cognitive Multisensory Rehabilitation for Reduced Neuropathic Pain in People With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Neuropathic Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Pain Numeric Rating Scale (NPRS) - part of the International SCI Basic Pain Data Set
timeFrame: weekly during the two intervention periods (each 12 weeks)
Secondary outcomes:
measure: Physical Activity Recall Questionnaire
timeFrame: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
measure: Spielberger State-Trait Anxiety Inventory
timeFrame: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
measure: Moorong Self-Efficacy Scale (MSES)
timeFrame: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
measure: WHOQOL-BREF
timeFrame: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
measure: Revised Body Awareness Rating Questionnaire (BARQ)
timeFrame: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
measure: Tampa Scale For Kinesiophobia
timeFrame: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
measure: Physical Activity Enjoyment Scale (PACES)
timeFrame: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
measure: Patient Specific Functional Scale
timeFrame: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
measure: International SCI Basic Pain Data Set
timeFrame: baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of MInnesota (Brain Body Mind Lab, Division of Physical Therapy, Department of Rehab Med, Medical School)
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ann Van de Winckel, Van de Winckel
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.