ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02395874
Recruitment Status : Recruiting
First Posted : March 24, 2015
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Cordula Werner, Medical Park AG

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.

Condition or disease Intervention/treatment Phase
Aphasia, Global Stroke Transcranial Direct Current Stimulation Speech Therapy Procedure: tDCS + speech therapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: verum-tDCS
verum-tDCS+ speech therapy
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.

Sham Comparator: sham-tDCS
sham-tDCS + speech therapy
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.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Aphasic depression rating scale (ADRS, 0-32) [ Time Frame: 5 min ]
    rates the depression in patients with aphasia

  2. Alterskonzentrationstest (AKT, 0-35) [ Time Frame: 5 min ]
    assesses the concentration and vigilance of elderly people with stroke

  3. Barthel-Index (BI,0-100) [ Time Frame: 5min ]
    evaluates the activities of daily living in patients suffering from stroke

  4. Rivermead Motor Assessment - Arm (RMA, 0-15) [ Time Frame: 5-10 min ]
    assesses the motor control of the upper extremity in patients with stroke


Other Outcome Measures:
  1. Electroencephalography (EEG) [ Time Frame: 30min ]
    to record spontaneous brain activity and to exclude increased cortical excitability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395874


Contacts
Contact: Stefan Hesse, Prof.Dr. +49-30-300240 ext 9312 s.hesse@medicalpark.de
Contact: Cordula Werner, Dr +49-30-300240 ext 9271 cwerner@reha-hesse.de

Locations
Germany
Medical Park Berlin Humboldtmuehle Recruiting
Berlin, Germany, 13507
Contact: Stefan Hesse, Prof.    +49303002409310    s.hesse@medicalpark.de   
Contact: Cordula Werner, Dr.    +49303002409271    c.werner@medicalpark.de   
Sponsors and Collaborators
Medical Park AG
Investigators
Principal Investigator: Stefan Hesse, Prof. Dr. Medical Park Berlin, Charité - University Medicine Berlin

Publications of Results:
Responsible Party: Cordula Werner, Head of Research Lab, Medical Park AG
ClinicalTrials.gov Identifier: NCT02395874     History of Changes
Other Study ID Numbers: MP-LOGA
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Communication Disorders
Stroke
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders