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TDCS in Acute Stroke

NCT ID: NCT01701713

Last Updated: 2012-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Stroke

Keywords

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TDCS STROKE APHASIA NAMING

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TDCS - DKI ED2011

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

Group Type EXPERIMENTAL

DKI ED2011

Intervention Type DEVICE

Sham-TDCS

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

Group Type SHAM_COMPARATOR

Sham-TDCS

Intervention Type DEVICE

Interventions

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DKI ED2011

Intervention Type DEVICE

Sham-TDCS

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Brandenburg Klinik, Bernau, Germany

UNKNOWN

Sponsor Role collaborator

University of Potsdam

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Jan Jungehuelsing

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerhard J Jungehuelsing, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Stroke Research Berlin (CSB), Charité

Michael Joebges, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Brandenburgklinik Bernau

Locations

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Brandenburg Klinik Bernau

Bernau bei Berlin, Brandenburg, Germany

Site Status RECRUITING

Charité, Campus Benjamin Franklin, Dep. of Neurology

Berlin, State of Berlin, Germany

Site Status COMPLETED

Countries

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Germany

Central Contacts

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Gerhard J Jungehuelsing, MD

Role: CONTACT

Email: [email protected]

Isabell Wartenburger, Prof. MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Michael Joebges, Prof. MD

Role: primary

Other Identifiers

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EA4/109/08

Identifier Type: OTHER

Identifier Source: secondary_id

TDCS_CSB-Brandenburg

Identifier Type: -

Identifier Source: org_study_id