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
  Purpose

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
Stroke
Device: DKI ED2011
Device: Sham-TDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improved language [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701713

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

Locations
Germany
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, Germany
Investigators
Principal Investigator: Gerhard J Jungehuelsing, MD Center for Stroke Research Berlin (CSB), Charité
Principal Investigator: Michael Joebges, Prof. MD Brandenburgklinik Bernau
  More Information

No publications provided

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
Study First Received: September 26, 2012
Last Updated: October 5, 2012
Health Authority: Germany: Ethics Committee Charité

Keywords provided by Charite University, Berlin, Germany:
TDCS
STROKE
APHASIA
NAMING

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 16, 2014