Aphasia, Global, Speech Therapy, Stroke, Transcranial Direct Current Stimulation
Conditions
Brief summary
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
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.
Interventions
PROCEDUREtDCS + speech therapy
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.
Sponsors
Medical Park AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goodglass-Kaplan communication scale (GKS, 0-5) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alterskonzentrationstest (AKT, 0-35) | 5 min | assesses the concentration and vigilance of elderly people with stroke |
| Rivermead Motor Assessment - Arm (RMA, 0-15) | 5-10 min | assesses the motor control of the upper extremity in patients with stroke |
| Barthel-Index (BI,0-100) | 5min | evaluates the activities of daily living in patients suffering from stroke |
| Aphasic depression rating scale (ADRS, 0-32) | 5 min | rates the depression in patients with aphasia |
Other
| Measure | Time frame | Description |
|---|---|---|
| Electroencephalography (EEG) | 30min | to record spontaneous brain activity and to exclude increased cortical excitability |
Countries
Germany
Contacts
Primary ContactStefan Hesse, Prof.Dr.
Backup ContactCordula Werner, Dr
Outcome results
None listed