MP-LoGa: Bi-hemispheral Transcranial Direct Current Stimulation to Improve the Severe Aphasia in Subacute Stroke Patients: a Randomized, Placebo-controlled, Double Blinded Multi-center Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Goodglass-Kaplan communication scale (GKS, 0-5)
研究概览
简要总结
To study the effect of combined tDCS plus speech therapy compared to sham-tDCS plus speech therapy in subacute stroke patients suffering from moderate or severe aphasia. The patients will be randomized by a computer-generated lot. Assessment will be performed at study onset, after six weeks at the end of the specific intervention and 4 months after stroke onset for follow-up.
详细描述
Approximately 25% of all patients after stroke suffer from aphasia. The aphasia could be so severe, that the patient cannot produce any words at all, and so the communication ability is rather poor. In that case speech therapy is the most common therapy, but the functional outcome for the patient is often not sufficiently. The transcranial direct current stimulation (tDCS) might improve the outcome of speech therapy in patients with severe aphasia. The patients will be randomized either to verum stimulation (group A) or sham stimulation (group B). In group A they will receive every workday for 6 weeks 20min of tDCS with 2 mA in combination with a 30 min speech therapy. In group B they will receive every workday for 6 weeks 20min of tDCS with 0 mA in combination with a 30 min speech therapy. The anodal electrode will be placed in case of a total anterior circulation stroke on the homologous speech area on the right hemisphere and in case of a partial anterior circulation stroke perilesional on the left hemisphere. The cathode will be positioned contralateral.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first time stroke (ischemic or hemorrhagic), either with a total or partial anterior circulation stroke according to the Bamford classification
- •stroke interval 10-45 days
- •moderate or severe aphasia, i.e. Goodglass-Kaplan-Communication-Scale (GKS, 0,1 or 2)
- •native speaker - german
- •age 18-90
排除标准
- •other neurological diseases affecting the CNS
- •known history of epileptic fits, except for an immediate fit
- •signs in the EEG of increased cortical excitability
- •patients with hemicraniectomy
- •fluent aphasia, i.e. GKS 3,4 or 5
- •speech apraxia
- •reduced sensibility of the scalp
- •previously radiated scalp
- •metallic parts or implants in the brain
- •participation in other interventional studies
结局指标
主要结局
Goodglass-Kaplan communication scale (GKS, 0-5)
时间窗: 10-15 min
the GKS is an ordinal scale, which assesses the communication ability of the patient from 0 to 5.
Aphasia Check-list (ACL, 0-148)
时间窗: 30-45 min
a german tool to assess language (analogous to the Aachener Aphasie Test). it measures a) colour-figure test, b) word generation and c) single speech domains
次要结局
- Aphasic depression rating scale (ADRS, 0-32)(5 min)
- Barthel-Index (BI,0-100)(5min)
- Alterskonzentrationstest (AKT, 0-35)(5 min)
- Rivermead Motor Assessment - Arm (RMA, 0-15)(5-10 min)
研究者
Cordula Werner
Head of Research Lab
Medical Park AG