A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change in International Spinal Cord Injury Pain Basic Set Version 2.0 (SCI Pain Test) which includes the numerical pain rating scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incomplete or complete SCI/D of ≥3 months
- •Medically stable.
排除标准
- •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
结局指标
主要结局
Change in International Spinal Cord Injury Pain Basic Set Version 2.0 (SCI Pain Test) which includes the numerical pain rating scale
时间窗: 3 Months
The SCI Pain Test consists of a numeric pain rating scale with scores ranging from 0-10 where lower scores indicate less pain, and an assessment of interference of pain with daily activity, mood, and sleep, with scores ranging from 0-10 where lower scores indicate less interference in daily life. The SCI Pain Test will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Change in Brain Motor Control Assessment (BMCA)
时间窗: 3 Months
The EMG testing will be done with the BMCA. The BMCA protocol involves elements of relaxation, reinforcement, and voluntary movements to gather quantitative multichannel surface EMG data. BMCA will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment. Assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Change in ISNCSCI Neurologic exam (ASIA test)
时间窗: 3 Months
The ASIA test is a clinical test originally designed to describe the extent and severity of a patient's SCI/D. It consists of a pinprick sensory test (sharp versus dull with a safety pin); a touch sensory test (with a cotton ball) and a test of the strength of muscles. Each sensation test is scored from 0-54 right and left, and the muscle tests for upper and lower limbs are scored from 0-25 each. Higher scores indicate better function. The ASIA test will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Change in Neuromuscular Recovery Scale (NRS)
时间窗: 3 Months
The NRS includes 11 items rated from 1-4 focused on the capacity of the trunk and lower extremity muscles to perform tasks such as sit, trunk extension, sit to stand, walking, and step retraining. Higher scores indicate better performance. The NRS provides a functional recovery measure that focuses on non-compensatory recovery. The NRS will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
Change in Spinal Cord Injury Functional Index/Assistive Technology (SCI-FI/AT)
时间窗: 3 Months
The SCI-FI/AT consists of 32 items each rated from 0-4, where higher scores indicate better function. It reliably measures function in the domains of basic mobility, self-care, fine motor function, and ambulation. The SCI-FI/AT will be assessed at baseline, 8 weeks after intervention, and during 3-month follow-up assessment.
次要结局
- Change in World Health Organization Quality of Life Instruments (WHOQOL-BREF)(3 Months)
- Change in Kinesthetic and Visual Imagery Questionnaire (KVIQ)(3 Months)
- The Craig Handicap Assessment and Reporting Technique-Short Form (CHART-SF)(3 Months)
- Change in Pittsburgh Sleep Quality Index(3 Months)
- Change in Patient Health Questionnaire (PHQ-9)(3 Months)
- Change in Revised Body Awareness Rating Questionnaire(3 Months)
- Change in Moorong Self-Efficacy Scale (MSES)(3 Months)
- Change in Spielberger State Trait Anxiety Inventory(3 Months)
- Change in Tampa Scale for Fear of Re-Injury(3 Months)
- Change in Patient-Specific Functional Scale(3 Months)