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TDCS in Acute Stroke (TDCS-aphasia)

This study is currently recruiting participants.
Verified October 2012 by Charite University, Berlin, Germany
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Brandenburg Klinik, Bernau, Germany
University of Potsdam, Germany
Information provided by (Responsible Party):
Gerhard Jan Jungehuelsing, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01701713
First received: September 26, 2012
Last updated: October 5, 2012
Last verified: October 2012
History of Changes

September 26, 2012
October 5, 2012
June 2009
June 2013   (final data collection date for primary outcome measure)
skin irritation [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
skin irritation, other problems [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01701713 on ClinicalTrials.gov Archive Site
Improved language [ Time Frame: 2 months ] [ Designated as safety issue: No ]
improved picture naming
Same as current
Not Provided
Not Provided
 
TDCS in Acute Stroke
Safety Study of Transcranial Direct Current Stimulation in Aphasia Therapy in Acute and Post-acute Stroke

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Stroke
  • Device: DKI ED2011
  • Device: Sham-TDCS
  • Experimental: TDCS - DKI ED2011
    TDCS with DKI ED2011 session is followed by a behavioral naming therapy with different cues
    Intervention: Device: DKI ED2011
  • Sham Comparator: Sham-TDCS
    Sham-TDCS session is followed by a behavioral naming therapy with different cues
    Intervention: Device: Sham-TDCS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Gerhard J Jungehuelsing, MD jan.jungehuelsing@charite.de
Contact: Isabell Wartenburger, Prof. MD isabell.wartenburger@uni-potsdam.de
Germany
 
NCT01701713
TDCS_CSB-Brandenburg, EA4/109/08
No
Gerhard Jan Jungehuelsing, Charite University, Berlin, Germany
Charite University, Berlin, Germany
  • German Federal Ministry of Education and Research
  • Brandenburg Klinik, Bernau, Germany
  • University of Potsdam, Germany
Principal Investigator: Gerhard J Jungehuelsing, MD Center for Stroke Research Berlin (CSB), Charité
Principal Investigator: Michael Joebges, Prof. MD Brandenburgklinik Bernau
Charite University, Berlin, Germany
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP