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TDCS in Acute Stroke (TDCS-aphasia)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
German Federal Ministry of Education and Research
Brandenburg Klinik, Bernau, Germany
University of Potsdam
Information provided by (Responsible Party):
Gerhard Jan Jungehuelsing, Charite University, Berlin, Germany Identifier:
First received: September 26, 2012
Last updated: October 5, 2012
Last verified: October 2012
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 Intervention
Device: DKI ED2011
Device: Sham-TDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Safety Study of Transcranial Direct Current Stimulation in Aphasia Therapy in Acute and Post-acute Stroke

Resource links provided by NLM:

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

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

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

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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
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 identifier: NCT01701713

Brandenburg Klinik Bernau
Bernau, Brandenburg, Germany, 16321
Charité, Campus Benjamin Franklin, Dep. of Neurology
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 Identifier: NCT01701713     History of Changes
Other Study ID Numbers: TDCS_CSB-Brandenburg  EA4/109/08 
Study First Received: September 26, 2012
Last Updated: October 5, 2012

Keywords provided by Charite University, Berlin, Germany:

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on February 17, 2017