NCT02395874

tDCS and Speech Therapy to Improve Aphasia

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Medical Park AG · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	tDCS + 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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-04-01
• Completion: 2018-10-01
• First posted: 2015-03-24
• Last updated: 2016-09-13

Locations

1 site across 1 country: Germany