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

Primary Purpose

Post-Stroke Chronic Aphasia, Anomia (Word-retrieval Impairment)

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Intensive language therapy
Intensive language therapy
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Stroke Chronic Aphasia focused on measuring Intensive language therapy, Anomia, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charite, University Medicine, Dept. of NeurologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

sham tDCS

anodal tDCS

Arm Description

Outcomes

Primary Outcome Measures

Boston Naming Test

Secondary Outcome Measures

Boston Naming Test
The follow-up will be administered to assess the stability of the treatment gains
Naming performance during functional magnetic resonance scanning
assessed during overt picture naming task
Naming performance during functional magnetic resonance imaging
assessed during overt picture naming task

Full Information

First Posted
October 13, 2010
Last Updated
August 26, 2013
Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01221779
Brief Title
Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation
Acronym
CATS
Official Title
Chronic Aphasia - Improved by Intensive Training and Electrical Brain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research

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 out 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Stroke Chronic Aphasia, Anomia (Word-retrieval Impairment)
Keywords
Intensive language therapy, Anomia, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sham tDCS
Arm Type
Placebo Comparator
Arm Title
anodal tDCS
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Intensive language therapy
Intervention Description
2 weeks of daily computerized naming training, daily, 3 hours
Intervention Type
Behavioral
Intervention Name(s)
Intensive language therapy
Intervention Description
2 weeks of daily computerized naming training, daily, 3 hours
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Boston Naming Test
Description
The follow-up will be administered to assess the stability of the treatment gains
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
Description
assessed during overt picture naming task
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
Description
assessed during overt picture naming task
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
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus Meinzer, PhD
Phone
+49-(0)30-450-560
Ext
140
Email
marcus.meinzer@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Agnes Flöel, MD
Phone
+49-(0)30-450-560
Ext
284
Email
agnes.floeel@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Meinzer, PhD
Organizational Affiliation
Charite, University Medicine, Neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Agnes Flöel, MD
Organizational Affiliation
Charite, University Medicine, Neurology
Official's Role
Study Director
Facility Information:
Facility Name
Charite, University Medicine, Dept. of Neurology
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Meinzer, PhD
First Name & Middle Initial & Last Name & Degree
Agnes Flöel, MD

12. IPD Sharing Statement

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Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation

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