Clinical Trial: tDCS and Speech Therapy to Improve Aphasia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Medical Park AG

Current Primary Outcome:

  • Goodglass-Kaplan communication scale (GKS, 0-5) [ Time Frame: 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) [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Aphasic depression rating scale (ADRS, 0-32) [ Time Frame: 5 min ]
    rates the depression in patients with aphasia
  • Alterskonzentrationstest (AKT, 0-35) [ Time Frame: 5 min ]
    assesses the concentration and vigilance of elderly people with stroke
  • Barthel-Index (BI,0-100) [ Time Frame: 5min ]
    evaluates the activities of daily living in patients suffering from stroke
  • Rivermead Motor Assessment - Arm (RMA, 0-15) [ Time Frame: 5-10 min ]
    assesses the motor control of the upper extremity in patients with stroke


Original Secondary Outcome: Same as current

Information By: Medical Park AG

Dates:
Date Received: March 11, 2015
Date Started: May 2015
Date Completion: October 2018
Last Updated: September 12, 2016
Last Verified: September 2016