- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01221779
Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation (CATS)
Chronic Aphasia - Improved by Intensive Training and Electrical Brain
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Marcus Meinzer, PhD
- Phone Number: 140 +49-(0)30-450-560
- Email: marcus.meinzer@charite.de
Study Contact Backup
- Name: Agnes Flöel, MD
- Phone Number: 284 +49-(0)30-450-560
- Email: agnes.floeel@charite.de
Study Locations
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-
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Berlin, Germany
- Recruiting
- Charite, University Medicine, Dept. of Neurology
-
Principal Investigator:
- Marcus Meinzer, PhD
-
Principal Investigator:
- Agnes Flöel, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Experimental: anodal tDCS
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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
Collaborators
Investigators
- Principal Investigator: Marcus Meinzer, PhD, Charite, University Medicine, Neurology
- Study Director: Agnes Flöel, MD, Charite, University Medicine, Neurology
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CATS01EO0801
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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