Identifying Body Awareness-related Brain Network Changes During Cognitive Multisensory Rehabilitation for Reduced Neuropathic Pain in People With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Pain Numeric Rating Scale (NPRS) - part of the International SCI Basic Pain Data Set
研究概览
简要总结
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.
详细描述
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.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •- MRI contra-indications (stabilizing hardware is typically MRI safe) including seizures, cognitive impairment, or other major medical complications
研究组 & 干预措施
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.
干预措施: Clinical Assessment (Behavioral)
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.
干预措施: Magnetic Resonance Imaging (MRI) (Behavioral)
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.
干预措施: OPTIONAL: blood draw (Other)
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.
干预措施: Usual Care (Other)
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.
干预措施: Cognitive Multisensory Therapy (Behavioral)
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.
干预措施: Clinical Assessment (Behavioral)
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.
干预措施: Magnetic Resonance Imaging (MRI) (Behavioral)
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.
干预措施: OPTIONAL: blood draw (Other)
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.
干预措施: Cognitive Multisensory Therapy (Behavioral)
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.
干预措施: Usual Care (Other)
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.
干预措施: Clinical Assessment (Behavioral)
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.
干预措施: Magnetic Resonance Imaging (MRI) (Behavioral)
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.
干预措施: OPTIONAL: blood draw (Other)
结局指标
主要结局
Pain Numeric Rating Scale (NPRS) - part of the International SCI Basic Pain Data Set
时间窗: weekly during the two intervention periods (each 12 weeks)
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.
次要结局
- 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))
- WHOQOL-BREF(baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks))
- Revised Body Awareness Rating Questionnaire (BARQ)(baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks))
- Tampa Scale For Kinesiophobia(baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks))
- Physical Activity Enjoyment Scale (PACES)(baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks))
- Patient Specific Functional Scale(baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks))
- International SCI Basic Pain Data Set(baseline - mid evaluation (after 12 weeks) - final evaluation (after second period of 12 weeks))