Safety Study of Transcranial Direct Current Stimulation in Aphasia Therapy in Acute and Post-acute Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- skin irritation
研究概览
简要总结
The purpose of this study is to determine the safety of transcranial direct current stimulation in aphasia therapy in acute and post-acute stroke.
详细描述
TDCS has been shown to have a positive effect on clinical outcome in both motor rehabilitation and aphasia treatment in chronic aphasic patients. In healthy subjects the method sped up reaction times in naming and language learning tasks. In TDCS a weak current is applied to the subjects head increasing excitatory activity which might lead to improved brain function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first media stroke
- •language impairment
- •informed consent
- •right handedness
- •NIHSS < 20
排除标准
- •previous Epilepsy oder epileptogenic events
- •epilepsy typical elements in EEG
- •hypersensitive skin (head)
- •metal implants (head)
- •pace maker or other electronic implants
- •previous head/brain surgery
- •medication reducing seizure threshold
- •previous psychiatric events
研究组 & 干预措施
Sham-TDCS
Sham-TDCS session is followed by a behavioral naming therapy with different cues
干预措施: Sham-TDCS (Device)
TDCS - DKI ED2011
TDCS with DKI ED2011 session is followed by a behavioral naming therapy with different cues
干预措施: DKI ED2011 (Device)
结局指标
主要结局
skin irritation
时间窗: 2 months
次要结局
- Improved language(2 months)
研究者
Gerhard Jan Jungehuelsing
MD
Charite University, Berlin, Germany