TDCS in Acute Stroke
TDCS-aphasia
Safety Study of Transcranial Direct Current Stimulation in Aphasia Therapy in Acute and Post-acute Stroke
2 other identifiers
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Jun 2009
Longer than P75 for not_applicable stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 26, 2012
CompletedFirst Posted
Study publicly available on registry
October 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedOctober 8, 2012
October 1, 2012
4 years
September 26, 2012
October 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
skin irritation
2 months
Secondary Outcomes (1)
Improved language
2 months
Study Arms (2)
TDCS - DKI ED2011
EXPERIMENTALTDCS with DKI ED2011 session is followed by a behavioral naming therapy with different cues
Sham-TDCS
SHAM COMPARATORSham-TDCS session is followed by a behavioral naming therapy with different cues
Interventions
Eligibility Criteria
You may qualify if:
- first media stroke
- language impairment
- informed consent
- right handedness
- NIHSS \< 20
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Charite University, Berlin, Germanylead
- German Federal Ministry of Education and Researchcollaborator
- Brandenburg Klinik, Bernau, Germanycollaborator
- University of Potsdamcollaborator
Study Sites (2)
Brandenburg Klinik Bernau
Bernau bei Berlin, Brandenburg, 16321, Germany
Charité, Campus Benjamin Franklin, Dep. of Neurology
Berlin, State of Berlin, 12200, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard J Jungehuelsing, MD
Center for Stroke Research Berlin (CSB), Charité
- PRINCIPAL INVESTIGATOR
Michael Joebges, Prof. MD
Brandenburgklinik Bernau
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 26, 2012
First Posted
October 5, 2012
Study Start
June 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
October 8, 2012
Record last verified: 2012-10