tDCS and Speech Therapy to Improve Aphasia

NCT ID: NCT02395874

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-10-31

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 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

Aphasia, Global; Stroke; Transcranial Direct Current Stimulation; Speech Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

verum-tDCS

verum-tDCS+ speech therapy

Group Type: EXPERIMENTAL

tDCS + speech therapy

Intervention Type: PROCEDURE

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-tDCS

sham-tDCS + speech therapy

Group Type: SHAM_COMPARATOR

tDCS + speech therapy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Park AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Cordula Werner

Head of Research Lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Hesse, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical Park Berlin, Charité - University Medicine Berlin

Locations

Medical Park Berlin Humboldtmuehle

Berlin, State of Berlin, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Stefan Hesse, Prof.Dr.

Role: CONTACT

s.hesse@medicalpark.de

+49-30-300240 ext. 9312

Cordula Werner, Dr

Role: CONTACT

cwerner@reha-hesse.de

+49-30-300240 ext. 9271

Facility Contacts

Stefan Hesse, Prof.

Role: primary

s.hesse@medicalpark.de

+49303002409310

Cordula Werner, Dr.

Role: backup

c.werner@medicalpark.de

+49303002409271

References

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.

Reference Type: RESULT

PMID: 21825004 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24166562 (View on PubMed)

Other Identifiers

MP-LOGA

Identifier Type: -

Identifier Source: org_study_id