Clinical trial NCT05167032: A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults With Spinal Cord Injury
Official title: A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To provide an effective treatment for recovery from paralysis and improved quality of life of veterans, military, and civilians with spinal cord injury/disorder (SCI/D). This is a mechanistic Phase I randomized pilot clinical trial in 16 adults with SCI/D. The investigators will compare the effects of Cognitive Multisensory Rehabilitation (CMR) vs. adaptive fitness on sensorimotor function. Objective 1: Determine if 8 weeks of CMR improves sensory and motor function in adults with SCI/D. Objective 2: Determine if 8 weeks of CMR restores brain activity and connectivity related to sensorimotor function in adults with SCI/D.

Detailed description: About 296,000 Americans with a spinal cord injury/disorder (SCI/D) suffer from reduced or complete loss of sensory and motor function and 26% of adults with SCI receive care through the Veterans Affairs (VA). Motor and sensory impairments, including the loss of awareness of where limbs are in space, greatly compromise functional independence and quality of life. Damage to sensory and motor spinal pathways after SCI/D disrupts the bidirectional communication of sensory and motor information between the brain and the spinal cord, resulting in altered brain function in the sensorimotor cortex. Yet, an in-depth understanding of how exactly SCI/D impairs brain function, sensation and movement is largely unknown. Available treatments show mixed results for sensorimotor recovery, perhaps because it is unclear yet which specific brain areas to target. This highlights a need to develop brain mechanism-based treatments that restore brain function and improve sensation and movement after SCI/D. The investigators' brain imaging studies indicate that connections from two brain areas, the parietal operculum (parts OP1/OP4) and insula, are weaker in adults with SCI/D than in healthy adults. These connections are an essential part of the sensorimotor network. Thus, restoration of those network connections may lead to improved sensorimotor function after SCI/D. Previously, the investigators reported in adults 1-7 years post-stroke that OP1/OP4-insula connectivity restored alongside significantly improved sensorimotor function, by applying a physical therapy approach termed "Cognitive Multisensory Rehabilitation" (CMR). Based on these results, the investigators hypothesize that CMR restores brain connections related to sensorimotor function by strengthening OP1/OP4 and insula connections in adults with SCI/D. For this study, the investigators propose to test the hypothesis by carrying out the following objectives:

Objective 1: Determine if 8 weeks of CMR improves sensory and motor function in adults with SCI/D. The investigators will use quantitative measures used in clinical practice, and EMG testing to quantify changes in sensory and motor function. As secondary outcomes, the investigators will assess mood, life satisfaction, and community integration.

Hypothesis 1. CMR in comparison to adaptive fitness will improve sensorimotor function after SCI/D. Sensorimotor function will be associated with mood, life satisfaction, and community integration.

Objective 2: Determine if 8 weeks of CMR restores brain activity and connectivity related to sensorimotor function in adults with SCI/D. The investigators will assess changes in brain activation and connectivity in response to CMR vs adaptive fitness by resting-state and 4 task-based functional Magnetic Resonance Imaging (fMRI).

Hypothesis 2. CMR will restore OP1/OP4 and insula connectivity with other sensorimotor-related brain areas. These brain function changes will be associated with sensory and motor improvements.

Eligibility criteria: Inclusion Criteria:

* Incomplete or complete SCI/D of ≥3 months
* Medically stable.

Exclusion Criteria:

* MRI contra-indications (stabilizing hardware is typically MRI safe)
* Uncontrolled seizure disorder
* Cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent individuals from following directions or from learning
* Ventilator dependency
* Other major medical complications
* Pregnancy

Primary outcomes:
measure: Change in Brain Motor Control Assessment (BMCA)
timeFrame: 3 Months
measure: Change in ISNCSCI Neurologic exam (ASIA test)
timeFrame: 3 Months
measure: Change in Neuromuscular Recovery Scale (NRS)
timeFrame: 3 Months
measure: Change in Spinal Cord Injury Functional Index/Assistive Technology (SCI-FI/AT)
timeFrame: 3 Months
measure: Change in International Spinal Cord Injury Pain Basic Set Version 2.0 (SCI Pain Test) which includes the numerical pain rating scale
timeFrame: 3 Months
Secondary outcomes:
measure: Change in Pittsburgh Sleep Quality Index
timeFrame: 3 Months
measure: Change in Spielberger State Trait Anxiety Inventory
timeFrame: 3 Months
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: 3 Months
measure: Change in World Health Organization Quality of Life Instruments (WHOQOL-BREF)
timeFrame: 3 Months
measure: Change in Revised Body Awareness Rating Questionnaire
timeFrame: 3 Months
measure: Change in Kinesthetic and Visual Imagery Questionnaire (KVIQ)
timeFrame: 3 Months
measure: Change in Moorong Self-Efficacy Scale (MSES)
timeFrame: 3 Months
measure: Change in Tampa Scale for Fear of Re-Injury
timeFrame: 3 Months
measure: Change in Patient-Specific Functional Scale
timeFrame: 3 Months
measure: The Craig Handicap Assessment and Reporting Technique-Short Form (CHART-SF)
timeFrame: 3 Months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota Medical School Department of Rehabilitation Medicine
name: Ann Van de Winckel, PhD, MSPT, PT
role: PRINCIPAL_INVESTIGATOR
References: