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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Marcus Meinzer, Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01221779
First Posted: October 15, 2010
Last Update Posted: August 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Marcus Meinzer, Charite University, Berlin, Germany
  Purpose
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

Condition Intervention Phase
Post-Stroke Chronic Aphasia Anomia (Word-retrieval Impairment) Behavioral: Intensive language therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chronic Aphasia - Improved by Intensive Training and Electrical Brain

Resource links provided by NLM:


Further study details as provided by Marcus Meinzer, Charite University, Berlin, Germany:

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

Secondary Outcome Measures:
  • 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

  • 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

  • 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


Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: sham tDCS Behavioral: Intensive language therapy
2 weeks of daily computerized naming training, daily, 3 hours
Experimental: anodal tDCS Behavioral: Intensive language therapy
2 weeks of daily computerized naming training, daily, 3 hours

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221779


Contacts
Contact: Marcus Meinzer, PhD +49-(0)30-450-560 ext 140 marcus.meinzer@charite.de
Contact: Agnes Flöel, MD +49-(0)30-450-560 ext 284 agnes.floeel@charite.de

Locations
Germany
Charite, University Medicine, Dept. of Neurology Recruiting
Berlin, Germany
Principal Investigator: Marcus Meinzer, PhD         
Principal Investigator: Agnes Flöel, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Marcus Meinzer, PhD Charite, University Medicine, Neurology
Study Director: Agnes Flöel, MD Charite, University Medicine, Neurology
  More Information

Responsible Party: Marcus Meinzer, Creutzfeldt Fellow, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01221779     History of Changes
Other Study ID Numbers: CATS01EO0801
First Submitted: October 13, 2010
First Posted: October 15, 2010
Last Update Posted: August 27, 2013
Last Verified: August 2013

Keywords provided by Marcus Meinzer, Charite University, Berlin, Germany:
Intensive language therapy
Anomia
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Aphasia
Anomia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms