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tDCS and Speech Therapy to Improve Aphasia

NCT02395874 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2016-09-13

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Medical Park AG

    lead INDUSTRY

Principal Investigators

  • Stefan Hesse, Prof. Dr. · Medical Park Berlin, Charité - University Medicine Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-04-30
Completion
2018-10-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02395874 on ClinicalTrials.gov