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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
Sponsor:
Information provided by (Responsible Party):
Marcus Meinzer, Charite University, Berlin, Germany

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Residual Aphasia Device: atDCS Device: sham tDCS Not Applicable

Detailed 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

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia
U.S. FDA Resources

Arms and Interventions
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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
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]

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

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)
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Contact: Robert Darkow, MSc +49 30 450 560 ext 395 robert.darkow@charite.de

Locations
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         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Marcus Meinzer, PhD Charite, University Medicine, Neurology
Principal Investigator: Agnes Flöel, MD Charite, University Medicine, Neurology
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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