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Clinical Trials/NCT01221779
NCT01221779
Unknown
Phase 2

Chronic Aphasia - Improved by Intensive Training and Electrical Brain

Charite University, Berlin, Germany1 site in 1 country40 target enrollmentJanuary 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Post-Stroke Chronic Aphasia
Sponsor
Charite University, Berlin, Germany
Enrollment
40
Locations
1
Primary Endpoint
Boston Naming Test
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
December 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marcus Meinzer

Creutzfeldt Fellow

Charite University, Berlin, Germany

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

Outcomes

Primary Outcomes

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 Outcomes

  • Boston Naming Test(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(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(Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up))

Study Sites (1)

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