Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation

NCT ID: NCT01221779

Last Updated: 2013-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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Intensive language therapy Anomia Magnetic Resonance Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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sham tDCS

Group Type PLACEBO_COMPARATOR

Intensive language therapy

Intervention Type BEHAVIORAL

2 weeks of daily computerized naming training, daily, 3 hours

anodal tDCS

Group Type EXPERIMENTAL

Intensive language therapy

Intervention Type BEHAVIORAL

2 weeks of daily computerized naming training, daily, 3 hours

Interventions

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Intensive language therapy

2 weeks of daily computerized naming training, daily, 3 hours

Intervention Type BEHAVIORAL

Intensive language therapy

2 weeks of daily computerized naming training, daily, 3 hours

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Marcus Meinzer

Creutzfeldt Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcus Meinzer, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite, University Medicine, Neurology

Agnes Flöel, MD

Role: STUDY_DIRECTOR

Charite, University Medicine, Neurology

Locations

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Charite, University Medicine, Dept. of Neurology

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Marcus Meinzer, PhD

Role: CONTACT

Phone: +49-(0)30-450-560

Email: [email protected]

Agnes Flöel, MD

Role: CONTACT

Phone: +49-(0)30-450-560

Email: [email protected]

Other Identifiers

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CATS01EO0801

Identifier Type: -

Identifier Source: org_study_id