Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation (CATS)

August 26, 2013 updated by: Marcus Meinzer, Charite University, Berlin, Germany

Chronic Aphasia - Improved by Intensive Training and Electrical Brain

The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the out of intensive language therapy in chronic aphasia

Study Overview

Detailed Description

Stroke is the leading cause of death and disability worldwide. Given the increasing average lifespan worldwide, the incidence and prevalence of patients with stroke will dramatically increase in the future. One of the most frequent and devastating conditions after stroke is aphasia, which affects language production and comprehension. High-frequent intensive speech-and-language therapy is currently the treatment of choice in chronic aphasia. However, despite its general effectiveness, treatment effect sizes are only low to moderate. Thus, there is a pressing need to explore novel training-adjuvant therapies to enhance treatment efficacy. Moreover, very little is known about the neurobiology of treatment-induced recovery in chronic aphasia. This is the prerequisite to improve existing and/or develop new treatment paradigms.

Thus, in the present project we aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. We will be using anodal transcranial direct current stimulation (atDCS) that has previously been shown to enhance (a) language and motor learning in healthy subjects and (b) motor recovery in stroke patients. Specifically, in a longitudinal group comparison design, two matched groups of patients with chronic anomia will receive two weeks of intensive language training with or without atDCS. Treatment effects will be assessed immediately after the two week intervention period and several months after the end of the training. We will also use functional and structural magnetic resonance imaging (MRI) to elucidate language network changes in the two groups.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

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

      • Berlin, Germany
        • Recruiting
        • Charite, University Medicine, Dept. of Neurology
        • Principal Investigator:
          • Marcus Meinzer, PhD
        • Principal Investigator:
          • Agnes Flöel, MD

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • right-handedness
  • single first time left-hemisphere stroke
  • fluent- or non-fluent chronic aphasia (more than six months post-stroke)
  • anomia (PR>10 and PR<60 Aachen Aphasia Naming Subtest)
  • native German Speaker

Exclusion Criteria:

  • more than one stroke
  • alcoholism, severe psychiatric conditions, other neurological conditions
  • other non-treated medical problems, severe microangiopathy
  • pregnancy

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: sham tDCS
2 weeks of daily computerized naming training, daily, 3 hours
Experimental: anodal tDCS
2 weeks of daily computerized naming training, daily, 3 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Boston Naming Test
Time Frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston Naming Test
Time Frame: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
The follow-up will be administered to assess the stability of the treatment gains
Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
Naming performance during functional magnetic resonance scanning
Time Frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
assessed during overt picture naming task
Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
Naming performance during functional magnetic resonance imaging
Time Frame: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
assessed during overt picture naming task
Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Marcus Meinzer, PhD, Charite, University Medicine, Neurology
  • Study Director: Agnes Flöel, MD, Charite, University Medicine, Neurology

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, 2011

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

October 13, 2010

First Submitted That Met QC Criteria

October 14, 2010

First Posted (Estimate)

October 15, 2010

Study Record Updates

Last Update Posted (Estimate)

August 27, 2013

Last Update Submitted That Met QC Criteria

August 26, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Post-Stroke Chronic Aphasia

Clinical Trials on Intensive language therapy

3
Subscribe