Clinical trial NCT02395874: tDCS and Speech Therapy to Improve Aphasia
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aphasia, Global
Stroke
Transcranial Direct Current Stimulation
Speech Therapy
Lead sponsor: Medical Park AG
Sponsor class: INDUSTRY
First posted: 2015-03-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Goodglass-Kaplan communication scale (GKS, 0-5)
timeFrame: 10-15 min
measure: Aphasia Check-list (ACL, 0-148)
timeFrame: 30-45 min
Secondary outcomes:
measure: Aphasic depression rating scale (ADRS, 0-32)
timeFrame: 5 min
measure: Alterskonzentrationstest (AKT, 0-35)
timeFrame: 5 min
measure: Barthel-Index (BI,0-100)
timeFrame: 5min
measure: Rivermead Motor Assessment - Arm (RMA, 0-15)
timeFrame: 5-10 min
Other outcomes:
measure: Electroencephalography (EEG)
timeFrame: 30min
Locations:
city: Berlin
country: Germany
facility: Medical Park Berlin Humboldtmuehle
Study officials:
affiliation: Medical Park Berlin, Charité - University Medicine Berlin
name: Stefan Hesse, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.