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TDCS in Acute Stroke (TDCS-aphasia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01701713
Recruitment Status : Unknown
Verified October 2012 by Gerhard Jan Jungehuelsing, Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : October 5, 2012
Last Update Posted : October 8, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the safety of transcranial direct current stimulation in aphasia therapy in acute and post-acute stroke.

Condition or disease Intervention/treatment
Stroke Device: DKI ED2011 Device: Sham-TDCS

Detailed Description:
TDCS has been shown to have a positive effect on clinical outcome in both motor rehabilitation and aphasia treatment in chronic aphasic patients. In healthy subjects the method sped up reaction times in naming and language learning tasks. In TDCS a weak current is applied to the subjects head increasing excitatory activity which might lead to improved brain function.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Safety Study of Transcranial Direct Current Stimulation in Aphasia Therapy in Acute and Post-acute Stroke
Study Start Date : June 2009
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: TDCS - DKI ED2011
TDCS with DKI ED2011 session is followed by a behavioral naming therapy with different cues
Device: DKI ED2011
Sham Comparator: Sham-TDCS
Sham-TDCS session is followed by a behavioral naming therapy with different cues
Device: Sham-TDCS

Outcome Measures

Primary Outcome Measures :
  1. skin irritation [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Improved language [ Time Frame: 2 months ]
    improved picture naming

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • first media stroke
  • language impairment
  • informed consent
  • right handedness
  • NIHSS < 20

Exclusion Criteria:

  • previous Epilepsy oder epileptogenic events
  • epilepsy typical elements in EEG
  • hypersensitive skin (head)
  • metal implants (head)
  • pace maker or other electronic implants
  • previous head/brain surgery
  • medication reducing seizure threshold
  • previous psychiatric events
Contacts and Locations

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): NCT01701713

Contact: Gerhard J Jungehuelsing, MD jan.jungehuelsing@charite.de
Contact: Isabell Wartenburger, Prof. MD isabell.wartenburger@uni-potsdam.de

Brandenburg Klinik Bernau Recruiting
Bernau, Brandenburg, Germany, 16321
Contact: Michael Joebges, Prof. MD       Joebges@Brandenburgklinik.de   
Principal Investigator: Michael Joebges, Prof. MD         
Charité, Campus Benjamin Franklin, Dep. of Neurology Completed
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Brandenburg Klinik, Bernau, Germany
University of Potsdam
Principal Investigator: Gerhard J Jungehuelsing, MD Center for Stroke Research Berlin (CSB), Charité
Principal Investigator: Michael Joebges, Prof. MD Brandenburgklinik Bernau
More Information

Responsible Party: Gerhard Jan Jungehuelsing, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01701713     History of Changes
Other Study ID Numbers: TDCS_CSB-Brandenburg
EA4/109/08 ( Other Identifier: Charité Ethics Committee )
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: October 8, 2012
Last Verified: October 2012

Keywords provided by Gerhard Jan Jungehuelsing, Charite University, Berlin, Germany:

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases