Effect of Daily Left Prefrontal Dorsolateral Transcranial Direct Current Stimulation Sessions on Cognitive Improvement in Patients With Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in the CRS-R total score
研究概览
简要总结
In this study, researchers will show to caregivers of patients how to use a tDCS device (this device was designed to be easy to use, with fixed parameters and only one button to press to run the stimulation). They will be asked to apply a stimulation every day, 5 days per week during for 4 weeks, in chronic patients in minimally conscious state (MCS).
2 sessions of 4 weeks of stimulations will be realized, one anodal and one sham in a randomized order. Before and after each session, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 8 weeks after the end of the sessions to assess the long term effect of tDCS.
详细描述
A single session of tDCS showed positive effects on patients in MCS (study published in Neurology, 2014). Nevertheless, the effects went down after 1 or 2 hours. In a second study (Protocol ID: 2009/201/B) we have found that 5 days of tDCS increase the lasting of the effects up to one week.
To know if tDCS could be use in clinical daily practice, a new study will evaluate the effects of 20 minutes of tDCS over the left prefrontal dorsolateral cortex for 4 weeks, 5 days per week, in chronic patients in MCS.
2 sessions of 4 weeks of stimulation (total=20 stimulations per session) will be performed, one session will be real (anodal stimulation) and one placebo (sham stimulation).
Firstly, the patient will be seen at the hospital for a behavioral assessment (CRS-R) with one of his/her caregiver. The investigator will explain to the caregiver how to perform the stimulation. In addition, he/she will receive a folder and a video. The caregiver will take an exam to be sure he/she performs the tDCS properly.
Before and after each stimulation session, behavioral improvement will be assessed with the CRS-R by a trained neuropsychologist, at the hospital. A final assessment will be done 8 weeks after the end of the session to assess the long term effect of tDCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be in an minimally conscious state
- •be chronic (more then 3 months post insult)
- •stable condition
排除标准
- •NMDA receptor inhibitor drugs
- •modification of the treatment during the protocol
- •illness or infection during the protocol
- •pacemaker
- •metallic cerebral implant
- •prior neurological disorder
- •tDCS or other non-invasive brain stimulation treatment less than 3months before the inclusion in the present study
结局指标
主要结局
Change in the CRS-R total score
时间窗: after each stimulation sessions (4 weeks) and 8 weeks later
Improvement of the CRS-R total score after the end of the anodal session and 8 weeks later but no change for the sham session.
Safety of the device (adverse effect)
时间窗: Recorded after each stimulations sessions (4 weeks) and 8 weeks later
a questionnaire will be asked to the caregivers and family of the patient to know any adverse effect (drowsiness, redness of the skin, epileptic sizure, sign of pain or discomfort).
Usability of the device in daily clinical practice (compliance of the device by the caregivers)
时间窗: After the end of the protocol (24 weeks)
The tDCS device records the number of stimulations performed during the protocol. We will be able to evaluate the compliance of the device by the caregivers to know if they use it properly and as expected.
次要结局
未报告次要终点