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

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Transcranial Direct Current Stimulation; Speech Therapy; Aphasia, Global
• Intervention / Treatment: Procedure: tDCS + speech therapy

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
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan Hesse, Prof.Dr.; Phone Number: 9312 +49-30-300240; Email: s.hesse@medicalpark.de
• Study Contact Backup: Name: Cordula Werner, Dr; Phone Number: 9271 +49-30-300240; Email: cwerner@reha-hesse.de

Study Locations

• Germany
  • Berlin, Germany, 13507
    • Recruiting
    • Medical Park Berlin Humboldtmuehle
    • Contact: Stefan Hesse, Prof.; Phone Number: +49303002409310; Email: s.hesse@medicalpark.de
    • Contact: Cordula Werner, Dr.; Phone Number: +49303002409271; Email: c.werner@medicalpark.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goodglass-Kaplan communication scale (GKS, 0-5)	the GKS is an ordinal scale, which assesses the communication ability of the patient from 0 to 5.	10-15 min
Aphasia Check-list (ACL, 0-148)	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	30-45 min

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalography (EEG)	to record spontaneous brain activity and to exclude increased cortical excitability	30min

Collaborators and Investigators

• Sponsor: Medical Park AG
• Investigators: Principal Investigator: Stefan Hesse, Prof. Dr., Medical Park Berlin, Charité - University Medicine Berlin

Publications and helpful links

General Publications

• Hesse S, Waldner A, Mehrholz J, Tomelleri C, Pohl M, Werner C. Combined transcranial direct current stimulation and robot-assisted arm training in subacute stroke patients: an exploratory, randomized multicenter trial. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):838-46. doi: 10.1177/1545968311413906. Epub 2011 Aug 8.
• Polanowska KE, Lesniak M, Seniow JB, Czlonkowska A. No effects of anodal transcranial direct stimulation on language abilities in early rehabilitation of post-stroke aphasic patients. Neurol Neurochir Pol. 2013 Sep-Oct;47(5):414-22. doi: 10.5114/ninp.2013.38221.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: March 11, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimate): March 24, 2015

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Speech Disorders; Aphasia; Communication Disorders
• Other Study ID Numbers: MP-LOGA