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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| verum-tDCS | Experimental | verum-tDCS+ speech therapy |
|
| sham-tDCS | Sham Comparator | sham-tDCS + speech therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS + speech therapy | Procedure | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Electroencephalography (EEG) | to record spontaneous brain activity and to exclude increased cortical excitability | 30min |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Hesse, Prof.Dr. | Contact | +49-30-300240 | 9312 | s.hesse@medicalpark.de |
| Cordula Werner, Dr | Contact | +49-30-300240 | 9271 | cwerner@reha-hesse.de |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Hesse, Prof. Dr. | Medical Park Berlin, Charité - University Medicine Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Park Berlin Humboldtmuehle | Recruiting | Berlin | State of Berlin | 13507 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21825004 | Result | Hesse S, Waldner A, Mehrholz J, Tomelleri C, Pohl M, Werner C. Combined transcranial direct current stimulation and robot-assisted arm training in subacute stroke patients: an exploratory, randomized multicenter trial. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):838-46. doi: 10.1177/1545968311413906. Epub 2011 Aug 8. | |
| 24166562 |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D020521 | Stroke |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D013070 | Speech Therapy |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| 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 |
| Polanowska KE, Lesniak M, Seniow JB, Czlonkowska A. No effects of anodal transcranial direct stimulation on language abilities in early rehabilitation of post-stroke aphasic patients. Neurol Neurochir Pol. 2013 Sep-Oct;47(5):414-22. doi: 10.5114/ninp.2013.38221. |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |