Improvement of Language Disturbances After Stroke by Intensive Training and Electrical Brain Stimulation

NCT ID: NCT00822068

Last Updated: 2009-01-14

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

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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The study aims to identify if intensive language training, consisting mainly of computer-based object naming, together with electrical brain stimulation, will lead to an improvement of language functions in patients that suffer from language disturbances after a stroke.

Detailed Description

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Conditions

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Aphasia Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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anodal tDCS

Group Type EXPERIMENTAL

anodal tDCS

Intervention Type DEVICE

anodal transcranial direct current stimulation

2

cathodal tDCS

Group Type ACTIVE_COMPARATOR

cathodal tDCS

Intervention Type DEVICE

cathodal transcranial direct current stimulation

3

sham stimulation

Group Type PLACEBO_COMPARATOR

sham stimulation

Intervention Type DEVICE

sham stimulation

Interventions

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anodal tDCS

anodal transcranial direct current stimulation

Intervention Type DEVICE

cathodal tDCS

cathodal transcranial direct current stimulation

Intervention Type DEVICE

sham stimulation

sham stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* chronic stroke (\> 1 year after event)
* aphasia due to stroke with naming impairment
* German as first language
* first-ever stroke

Exclusion Criteria

* more than 1 stroke
* progressive stroke
* history of severe alcohol or drug abuse, psychiatric illnessess like severe depression, poor motivational capacity
* dementia
* contraindications for Magnetic Resonance Imaging
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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University of Muenster

Principal Investigators

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Agnes Floel, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University of Muenster; Department of Neurology, University of Berlin, Germany

Locations

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Department of Neurology, University of Muenster; Department of Neurology, University of Berlin

Muenster / Berlin, NRW/Berlin-Brandenburg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Agnes Floel, MD

Role: CONTACT

0049 251 83 ext. 45699

Caterina Breitenstein, PhD

Role: CONTACT

0049 251 83 ext. 49969

Facility Contacts

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Agnes Floel, MD

Role: primary

+49 251 83 ext. 45699

Caterina Breiteinstein, PhD

Role: backup

References

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Floel A, Meinzer M, Kirstein R, Nijhof S, Deppe M, Knecht S, Breitenstein C. Short-term anomia training and electrical brain stimulation. Stroke. 2011 Jul;42(7):2065-7. doi: 10.1161/STROKEAHA.110.609032. Epub 2011 Jun 2.

Reference Type DERIVED
PMID: 21636820 (View on PubMed)

Other Identifiers

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Aphasia_tDCS

Identifier Type: -

Identifier Source: org_study_id

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