Synergistic Potential of Non-invasive Brain and Spinal Cord Stimulation for Improving Sensorimotor and Cognitive Functions After Neurological Injury
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Sensory Performance
研究概览
简要总结
The goal of this clinical study is to investigate the potential synergy between non-invasive brain and spinal cord stimulation administered during a cognitive-motor task, in terms of their immediate effects on sensorimotor and cognitive functions after neurological injuries affecting the upper limb (cervical spinal cord injury and stroke). Secondary objectives are to evaluate the relevance of anatomical MRI, functional MRI, and neurophysiological measurements for optimizing and predicting the effects of these different interventions.
详细描述
Over the past decade, innovative electrical stimulation strategies have emerged to improve the effectiveness of conventional rehabilitation approaches following spinal cord injury or stroke. Transcranial direct current stimulation (tDCS) and transcutaneous spinal cord stimulation (tSCS) are two non-invasive stimulation techniques targeting respectively the brain and spinal cord. These techniques have demonstrated immediate and lasting positive effects on the recovery of lost neurological functions following damage to the brain (in the case of stroke) or the spinal cord (in the case of spinal cord injury). Functional improvements leading to a better quality of life have been demonstrated in response to tSCS or tDCS sessions combined with motor training. Recent studies suggest a potential synergistic effect of these two types of intervention, which we propose to characterize in control participants, participants with cervical spinal cord injury, and post-stroke participants.
OBJECTIVES: In this project, we seek to study the potential synergistic effects of an intervention combining non-invasive stimulation of the brain and spinal cord, administered during the performance of a cognitive-motor task, compared to a control intervention and each intervention administered separately, on the recovery of motor and cognitive-motor functions after neurological injury. Secondary objectives are to evaluate the relevance of anatomical MRI data and neurophysiological measurements for optimizing and predicting the effects of these different interventions.
METHODOLOGY/RESEARCH DESIGN: Single-center, prospective, comparative, randomized, crossover, and single-blind clinical study comparing four neuromodulation interventions: S1: tDCS, S2: tSCS, S3: tDCS-tSCS, S4: sham, administered during a cognitive-motor training task of the affected upper limb using the Armeo technology. Three groups of participants will be included: one control group, one group with cervical spinal cord injury, and one post-stroke group. The two groups with either spinal cord injury or stroke will participate in a total of nine visits: the inclusion visit, four testing visits, and four intervention visits. The control group will participate only in the inclusion and testing visits. Outcome measures will include neurophysiological and clinical performance measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CONTROL GROUP:
- •Over 18 years of age
- •Participant who has signed an informed consent form
- •Participant who is affiliated with and covered by the social security system
- •POST-STROKE GROUP:
- •Over 18 years of age
- •Who sustained a stroke more than 3 weeks ago
- •Considered medically stable by the medical investigator
- •Who has signed an informed consent form
- •Affiliated with and covered by the social security system
- •Over 18 years of age
- •Considered to have a complete or incomplete spinal cord injury (i.e., with a score on the Spinal Injury Association (ASIA) Impairment Scale (AIS) score from A to D)
- •Considered medically stable by the investigating physician
- •Presenting with quadriplegia due to cervical injury
- •Who has signed an informed consent form
- •Affiliated with and covered by the social security system.
排除标准
- •Suffering from a chronic condition
- •Skin problems or open wounds
- •History of epilepsy or seizures
- •Presence of a contraindication to the use of magnetic/electrical stimulation or MRI, including: cardiac pacemaker; implanted hearing aid; intraocular foreign body, shrapnel, or bullets; metal worker; pacemaker or neurostimulator; claustrophobia
- •Presence of implanted medical devices (cardiac valve, endovascular devices, ventricular shunt valve, surgical clips, metallic sutures, staples, stent, osteosynthesis or arthrodesis hardware) not classified as "MR Conditional" according to ASTM F
- •Individuals who are legally incompetent, under judicial protection, guardianship, or trusteeship
- •Pregnant and/or breastfeeding women
- •Individuals who refuse to be informed of any abnormalities that may be detected by MRI.
结局指标
主要结局
Sensory Performance
时间窗: Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
GRASSP subscores: Hand dorsal and palmar sensory function
Quantitative Prehension Performance
时间窗: Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25)
GRASSP Quantitative Prehension Subscore: Hand prehension motor performance
次要结局
- Cognitive performance(Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25))
- Safety of the intervention(Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25))
- Feasibility of the intervention(Immediately post-intervention at interventional visits 1, 2, 3, and 4 (days 14, 18, 21, 25))
- Neurophysiological assessment of posterior root-muscle reflexes(Immediately post-intervention at testing visit #2 (day 4))
研究者
Fabien Wagner
Principal investigator
Centre National de la Recherche Scientifique, France