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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Marcus Meinzer, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01221779
First received: October 13, 2010
Last updated: August 26, 2013
Last verified: August 2013

October 13, 2010
August 26, 2013
January 2011
August 2014   (final data collection date for primary outcome measure)
Boston Naming Test [ Time Frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01221779 on ClinicalTrials.gov Archive Site
  • Boston Naming Test [ Time Frame: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    assessed during overt picture naming task
Same as current
Not Provided
Not Provided
 
Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Post-Stroke Chronic Aphasia
  • Anomia (Word-retrieval Impairment)
Behavioral: Intensive language therapy
2 weeks of daily computerized naming training, daily, 3 hours
  • Placebo Comparator: sham tDCS
    Intervention: Behavioral: Intensive language therapy
  • Experimental: anodal tDCS
    Intervention: Behavioral: Intensive language therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
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
Germany
 
NCT01221779
CATS01EO0801
Yes
Marcus Meinzer, Charite University, Berlin, Germany
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Principal Investigator: Marcus Meinzer, PhD Charite, University Medicine, Neurology
Study Director: Agnes Flöel, MD Charite, University Medicine, Neurology
Charite University, Berlin, Germany
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP