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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Marcus Meinzer, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01845129
First received: April 30, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

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 Intervention
Residual Aphasia
Device: atDCS
Device: sham tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Marcus Meinzer, Creutzfeldt Fellow, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01845129     History of Changes
Other Study ID Numbers: RAPH_01EO0801
Study First Received: April 30, 2013
Last Updated: April 30, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014