tDCS and Speech Therapy to Improve Aphasia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Aphasia, Global, Stroke, Transcranial Direct Current Stimulation, Speech Therapy

Intervention / Treatment
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* Procedure: tDCS + speech therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: verum-tDCS<br>verum-tDCS+ speech therapy | Procedure: tDCS + speech therapy<br>* Patients either receive 20min of tDCS with 2mA + speech therapy every work for 6 weeks. The anodal electrode will be placed either on the homologous speech area (TACS) in the right hemisphere or on the speech area perilesional in the left hemisphere (PACS). The cathodal electrode will be placed contralateral. Patients in group B will follow the same protocol, except for the stimulation intensity (2 mA versus 0 mA) the speech therapist will apply the tdcs according to the protocol. The tdcs machine is out of sight of the patient, so that she/he does not see, whether the machine is switched on or not. In case of sham stimulation the device will be switched on very slowly for the first 20 s and will than be set back to 0mA within the following 10 s. So that the patient will feel also the characteristic tingling under the electrodes.<br>|
| Sham Comparator: sham-tDCS<br>sham-tDCS + speech therapy | Procedure: tDCS + speech therapy<br>* Patients either receive 20min of tDCS with 2mA + speech therapy every work for 6 weeks. The anodal electrode will be placed either on the homologous speech area (TACS) in the right hemisphere or on the speech area perilesional in the left hemisphere (PACS). The cathodal electrode will be placed contralateral. Patients in group B will follow the same protocol, except for the stimulation intensity (2 mA versus 0 mA) the speech therapist will apply the tdcs according to the protocol. The tdcs machine is out of sight of the patient, so that she/he does not see, whether the machine is switched on or not. In case of sham stimulation the device will be switched on very slowly for the first 20 s and will than be set back to 0mA within the following 10 s. So that the patient will feel also the characteristic tingling under the electrodes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goodglass-Kaplan communication scale (GKS, 0-5) | the GKS is an ordinal scale, which assesses the communication ability of the patient from 0 to 5. | 10-15 min | 
| Aphasia Check-list (ACL, 0-148) | 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 | 30-45 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aphasic depression rating scale (ADRS, 0-32) | rates the depression in patients with aphasia | 5 min | 
| Alterskonzentrationstest (AKT, 0-35) | assesses the concentration and vigilance of elderly people with stroke | 5 min | 
| Barthel-Index (BI,0-100) | evaluates the activities of daily living in patients suffering from stroke | 5min | 
| Rivermead Motor Assessment - Arm (RMA, 0-15) | assesses the motor control of the upper extremity in patients with stroke | 5-10 min |