tDCS and Speech Therapy to Improve Aphasia "MP-LOGA"

Recruiting

Phase N/A Results N/A

Trial Description

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

Interventions

  • TDCS + speech therapy Procedure
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: verum-tDCS
    Description: verum-tDCS+ speech therapy
    ARM 2: Kind: Experimental
    Label: sham-tDCS
    Description: sham-tDCS + speech therapy
  • TDCS + speech therapy Procedure
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: verum-tDCS
    Description: verum-tDCS+ speech therapy
    ARM 2: Kind: Experimental
    Label: sham-tDCS
    Description: sham-tDCS + speech therapy

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Goodglass-Kaplan communication scale (GKS, 0-5) 10-15 min Yes
Primary Aphasia Check-list (ACL, 0-148) 30-45 min No
Secondary Aphasic depression rating scale (ADRS, 0-32) 5 min No
Secondary Alterskonzentrationstest (AKT, 0-35) 5 min No
Secondary Barthel-Index (BI,0-100) 5min No
Secondary Rivermead Motor Assessment - Arm (RMA, 0-15) 5-10 min No

Sponsors