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

January 13, 2009 updated by: University Hospital Muenster

Improvement of Aphasia After Stroke by Intensive Training and Transcranial Direct Current Stimulation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • NRW/Berlin-Brandenburg
      • Muenster / Berlin, NRW/Berlin-Brandenburg, Germany, 48129/10098
        • Recruiting
        • Department of Neurology, University of Muenster; Department of Neurology, University of Berlin
        • Principal Investigator:
          • Agnes Flöel, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: anodal tDCS
Device: anodal tDCS
anodal transcranial direct current stimulation
Active Comparator: 2
cathodal tDCS
Device: cathodal tDCS
cathodal transcranial direct current stimulation
Placebo Comparator: 3
sham stimulation
Device: sham stimulation
sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of words correctly named after training plus tDCS
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Communicative-Activity-Log & Stroke-and-Aphasia-Quality-of-Life-Scale
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Principal Investigator: Agnes Floel, MD, Department of Neurology, University of Muenster; Department of Neurology, University of Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2009

Last Update Submitted That Met QC Criteria

January 13, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aphasia_tDCS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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