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TDCS in Acute Stroke (TDCS-aphasia)

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
DKI ED2011
Sham-TDCS
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring TDCS, STROKE, APHASIA, NAMING

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brandenburg Klinik BernauRecruiting
  • Charité, Campus Benjamin Franklin, Dep. of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

TDCS - DKI ED2011

Sham-TDCS

Arm Description

TDCS with DKI ED2011 session is followed by a behavioral naming therapy with different cues

Sham-TDCS session is followed by a behavioral naming therapy with different cues

Outcomes

Primary Outcome Measures

skin irritation

Secondary Outcome Measures

Improved language
improved picture naming

Full Information

First Posted
September 26, 2012
Last Updated
October 5, 2012
Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research, Brandenburg Klinik, Bernau, Germany, University of Potsdam
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1. Study Identification

Unique Protocol Identification Number
NCT01701713
Brief Title
TDCS in Acute Stroke
Acronym
TDCS-aphasia
Official Title
Safety Study of Transcranial Direct Current Stimulation in Aphasia Therapy in Acute and Post-acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research, Brandenburg Klinik, Bernau, Germany, University of Potsdam

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
TDCS, STROKE, APHASIA, NAMING

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TDCS - DKI ED2011
Arm Type
Experimental
Arm Description
TDCS with DKI ED2011 session is followed by a behavioral naming therapy with different cues
Arm Title
Sham-TDCS
Arm Type
Sham Comparator
Arm Description
Sham-TDCS session is followed by a behavioral naming therapy with different cues
Intervention Type
Device
Intervention Name(s)
DKI ED2011
Intervention Type
Device
Intervention Name(s)
Sham-TDCS
Primary Outcome Measure Information:
Title
skin irritation
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Improved language
Description
improved picture naming
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard J Jungehuelsing, MD
Email
jan.jungehuelsing@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Isabell Wartenburger, Prof. MD
Email
isabell.wartenburger@uni-potsdam.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard J Jungehuelsing, MD
Organizational Affiliation
Center for Stroke Research Berlin (CSB), Charité
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Joebges, Prof. MD
Organizational Affiliation
Brandenburgklinik Bernau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brandenburg Klinik Bernau
City
Bernau
State/Province
Brandenburg
ZIP/Postal Code
16321
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Joebges, Prof. MD
Email
Joebges@Brandenburgklinik.de
First Name & Middle Initial & Last Name & Degree
Michael Joebges, Prof. MD
Facility Name
Charité, Campus Benjamin Franklin, Dep. of Neurology
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Completed

12. IPD Sharing Statement

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TDCS in Acute Stroke

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