Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation (CATS)
Primary Purpose
Aphasia, Anomia (Word-Finding Impairment)
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Intensive language therapy
transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia
Eligibility Criteria
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
- history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity
- dementia
- contraindications for Magnetic Resonance Imaging or transcranial direct current stimulation
Sites / Locations
- ChariteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
anodal tDCS
sham tDCS
Arm Description
Intensive language therapy with anodal transcranial direct current stimulation
Intensive language therapy with Sham-tDCS
Outcomes
Primary Outcome Measures
naming performance
Secondary Outcome Measures
naming performance
Naming performance during functional magnetic resonance scanning
Naming performance during functional magnetic resonance imaging
Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT)
Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT)
Full Information
NCT ID
NCT01924702
First Posted
August 14, 2013
Last Updated
February 3, 2015
Sponsor
Charité Neurocure AG Flöel
1. Study Identification
Unique Protocol Identification Number
NCT01924702
Brief Title
Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation (CATS)
Official Title
Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation (CATS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charité Neurocure AG Flöel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the outcome of intensive language therapy in chronic aphasia.
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 the investigators aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. They 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. The Investigators will also use functional and structural magnetic resonance imaging (MRI) to elucidate language network changes in the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Anomia (Word-Finding Impairment)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anodal tDCS
Arm Type
Active Comparator
Arm Description
Intensive language therapy with anodal transcranial direct current stimulation
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
Intensive language therapy with Sham-tDCS
Intervention Type
Behavioral
Intervention Name(s)
Intensive language therapy
Intervention Description
2 weeks of daily computerized naming training, daily, 3 hours
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
1mA anodal over M1 primary motor cortex for 20min with 35cm/2 electrode, Cathode (100cm/2) contralateral
Primary Outcome Measure Information:
Title
naming performance
Time Frame
Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
Secondary Outcome Measure Information:
Title
naming performance
Time Frame
Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
Title
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)
Title
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)
Title
Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT)
Time Frame
Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
Title
Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT)
Time Frame
Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity
dementia
contraindications for Magnetic Resonance Imaging or transcranial direct current stimulation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Darkow
Phone
004930450560395
Email
robert.darkow@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Floeel, Prof MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Darkow
Phone
004930450560395
Email
robert.darkow@charite.de
12. IPD Sharing Statement
Learn more about this trial
Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation (CATS)
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