tDCS and Speech Therapy to Improve Aphasia (MP-LOGA)

Medical Park AG

Status: Unknown

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

Treatments: Procedure: tDCS + speech therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02395874

MP-LOGA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups

verum-tDCS

Experimental group

Description:

verum-tDCS+ speech therapy

Treatment:

Procedure: tDCS + speech therapy

sham-tDCS

Sham Comparator group

Description:

sham-tDCS + speech therapy

Treatment:

Procedure: tDCS + speech therapy