Improving Hand Recovery With Neuromodulation in Tetraplegia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in Spinal Cord Independence Measure
研究概览
简要总结
This study will examine a form of non-invasive brain stimulation applied with intensive therapy of the arm and hand. The goal of the study is to determine if arm and hand function can be improved in people with incomplete cervical spinal cord injury (neck spinal cord injury, tetraplegia). Participants will be assigned to receive either active or inactive non-invasive brain stimulation.
详细描述
This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of two groups by chance. One group will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their more impaired arm and hand, focusing on exercises that are meaningful to him/her.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •traumatic, incomplete cervical SCI sustained at neurological level C4-C7 and classified as B, C or D by the American Spinal Injury Association Impairment Scale (AIS);
- •sustained injury at least 1 year prior to enrollment (i.e., chronic); and
- •Men and women between the ages of 18-65.
排除标准
- •history of head injury, seizures, severe alcohol or drug abuse, or psychiatric illness;
- •cognitive deficits severe enough to preclude informed consent;
- •positive pregnancy test or being of childbearing age and not using appropriate contraception;
- •presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain;
- •decubitus ulcers that might interfere with intervention;
- •cardiac or neural pacemakers;
- •fixed UE contractures;
- •untreated depression;
- •concurrent participation in occupational therapy;
- •within 3 months of recruitment, an addition or change in the dosage of drugs known to exert detrimental effects on motor recovery.
结局指标
主要结局
Change in Spinal Cord Independence Measure
时间窗: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
This evaluates self-care, respiration and sphincter management, and mobility.
次要结局
- Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension(Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up)
- Change in Van Lieshout Test(Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up)
- Semi-structured interview about study(Immediately post-intervention, 4-month follow-up)
- Change in Canadian Occupational Performance Measure(Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up)
- Change in Medical Research Council Scale Upper Extremity Manual Muscle Test(Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up)
- Change in cortical motor map volume(Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up)
研究者
Sara Shahid Salles
Professor
University of Kentucky