Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia

Residual Aphasia Clinical Trial

— StimRAph  

Official title:

Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01845129
• Other study ID #: RAPH_01EO0801
• Status: Recruiting
• Phase: N/A
• First received: April 30, 2013
• Last updated: April 30, 2013
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2013
• Source: Charite University, Berlin, Germany
• Contact: Robert Darkow, MSc
• Phone: +49 30 450 560
• Email: robert.darkow[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The present study assesses whether language functions in patients with residual post-stroke aphasia can be improved by transcranial direct current stimulation administered to the primary motor cortex in the language dominant (left) hemisphere.

Description:

Patients will participate in two tDCS sessions (atDCS; sham) in a cross-over within subjects design. tDCS or placebo will be administered during simulatneous fMRI to assess neural signatures of the stimulation. Order of stimulation will be counterbalanced between subjects

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• right handedness

• German native speaker

• cerebrovascular stroke in left hemisphere (>6 months)

• mild aphasia (according to Aachen Aphasia Test Battery Classification, Huber et al., 1983)

• residual anomia in naming test (>75 correct responses)

Exclusion Criteria:

• other current or previous neurological or psychiatric diseases

• alcohol or drug abuse

• MRI contraindication (e.g. magnetic metal, pacemaker, claustrophobia)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Aphasia
• Residual Aphasia

Intervention

Device:
• atDCS
atDCS will be delivered with a constant current of 1 mA during simultaneous resting-state (RS) and task-related (picture naming) functional magnetic resonance imaging (fMRI). The current will be turned on prior to the RS-fMRI scan and continues for 20 minutes.
• sham tDCS
During sham the current will be increeased and decreased in a ramp-like fashion (10 sec)

Locations

Country	Name	City	State
Germany	Charite, University Medicine, Dept. of Neurology	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response latency during picture naming task (max. 80)	Subjects are assessed in a cross-over design. The primary outcome measure will be assessed twice in each subject, either during placebo ("sham) stimulation or active (anodal) stimulation with transcranial direct current stimulation. Order of stimulation will be counterbalanced across the group.	Change in response latency between assessment 1 (week 1) and assessment 2 (week 2), assessments 1 and 2 are seperated by one week	No
Secondary	Change in neural activity measured by functional magnetic resonance imaging		Change in fMRI activity between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week	No