tDCS and Speech Therapy to Improve Aphasia

NCT02395874 | Unknown DMC

• 1 other identifier: MP-LOGA
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Aphasic depression rating scale (ADRS, 0-32)

  5 min

• Alterskonzentrationstest (AKT, 0-35)

  5 min

• Barthel-Index (BI,0-100)

  5min

• Rivermead Motor Assessment - Arm (RMA, 0-15)

  5-10 min

Other Outcomes (1)

• Electroencephalography (EEG)

  30min

Study Arms (2)

verum-tDCS

EXPERIMENTAL

verum-tDCS+ speech therapy

Procedure: tDCS + speech therapy

sham-tDCS

SHAM COMPARATOR

sham-tDCS + speech therapy

Procedure: tDCS + speech therapy

Interventions

tDCS + speech therapy 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; verum-tDCS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Park AG: lead

Study Sites (1)

Medical Park Berlin Humboldtmuehle

Berlin, State of Berlin, 13507, Germany

RECRUITING

Related 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-Dec;25(9):838-46. doi: 10.1177/1545968311413906. Epub 2011 Aug 8.

  PMID: 21825004 RESULT

• 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.

  PMID: 24166562 RESULT

MeSH Terms

Conditions

Aphasia; Stroke; Communication Disorders

Interventions

Transcranial Direct Current Stimulation; Speech Therapy

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Stefan Hesse, Prof. Dr.

  Medical Park Berlin, Charité - University Medicine Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Hesse, Prof.Dr.

CONTACT

+49-30-300240; s.hesse@medicalpark.de

Cordula Werner, Dr

CONTACT

+49-30-300240; cwerner@reha-hesse.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Lab

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: March 24, 2015
• Study Start: May 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: October 1, 2018
• Last Updated: September 13, 2016

Record last verified: 2016-09

Locations

DE (1)