Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia (StimRAph)
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ClinicalTrials.gov Identifier: NCT01845129 |
Recruitment Status
: Unknown
Verified April 2013 by Marcus Meinzer, Charite University, Berlin, Germany.
Recruitment status was: Recruiting
First Posted
: May 3, 2013
Last Update Posted
: May 3, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Residual Aphasia | Device: atDCS Device: sham tDCS | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia |
Study Start Date : | April 2013 |
Estimated Primary Completion Date : | April 2014 |
Estimated Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: anodal tDCS
atDCS will be administered for 20 minutes with 1 milliampere (1 mA) to the left primary hand motor cortex
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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.
Device: sham tDCS
During sham the current will be increeased and decreased in a ramp-like fashion (10 sec)
|
Sham Comparator: sham tDCS
sham tDCS will be administered to the left primary hand motor cortex
|
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.
Device: sham tDCS
During sham the current will be increeased and decreased in a ramp-like fashion (10 sec)
|
- Response latency during picture naming task (max. 80) [ Time Frame: Change in response latency between assessment 1 (week 1) and assessment 2 (week 2), assessments 1 and 2 are seperated by one week ]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 neural activity measured by functional magnetic resonance imaging [ Time Frame: Change in fMRI activity between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845129
Contact: Robert Darkow, MSc | +49 30 450 560 ext 395 | robert.darkow@charite.de |
Germany | |
Charite, University Medicine, Dept. of Neurology | Recruiting |
Berlin, Germany, 10117 | |
Contact: Robert Darkow, MSc +49 30 450 560 ext 395 robert.darkow@charite.de | |
Principal Investigator: Marcus Meinzer, PhD | |
Principal Investigator: Agnes Flöel, MD |
Principal Investigator: | Marcus Meinzer, PhD | Charite, University Medicine, Neurology | |
Principal Investigator: | Agnes Flöel, MD | Charite, University Medicine, Neurology |
Responsible Party: | Marcus Meinzer, Creutzfeldt Fellow, Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT01845129 History of Changes |
Other Study ID Numbers: |
RAPH_01EO0801 |
First Posted: | May 3, 2013 Key Record Dates |
Last Update Posted: | May 3, 2013 |
Last Verified: | April 2013 |
Additional relevant MeSH terms:
Aphasia Speech Disorders Language Disorders Communication Disorders |
Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |