tDCS and Speech Therapy to Improve Aphasia

Stroke Clinical Trial

— MP-LOGA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02395874
• Other study ID #: MP-LOGA
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2015
• Last updated: September 12, 2016
• Start date: May 2015
• Est. completion date: October 2018

Study information

• Verified date: September 2016
• Source: Medical Park AG
• Contact: Stefan Hesse, Prof.Dr.
• Phone: +49-30-300240
• Email: s.hesse[@]medicalpark.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: October 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Germany	Medical Park Berlin Humboldtmuehle	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Medical Park AG

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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 — View Citation

Polanowska KE, Lesniak M, Seniów 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Electroencephalography (EEG)	to record spontaneous brain activity and to exclude increased cortical excitability	30min	Yes
Primary	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	Yes
Primary	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	No
Secondary	Aphasic depression rating scale (ADRS, 0-32)	rates the depression in patients with aphasia	5 min	No
Secondary	Alterskonzentrationstest (AKT, 0-35)	assesses the concentration and vigilance of elderly people with stroke	5 min	No
Secondary	Barthel-Index (BI,0-100)	evaluates the activities of daily living in patients suffering from stroke	5min	No
Secondary	Rivermead Motor Assessment - Arm (RMA, 0-15)	assesses the motor control of the upper extremity in patients with stroke	5-10 min	No