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

NCT ID: NCT01924702

Last Updated: 2015-02-04

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the outcome 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 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.

Conditions

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Aphasia Anomia (Word-Finding Impairment)

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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anodal tDCS

Intensive language therapy with anodal transcranial direct current stimulation

Group Type ACTIVE_COMPARATOR

Intensive language therapy

Intervention Type BEHAVIORAL

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

transcranial direct current stimulation

Intervention Type DEVICE

1mA anodal over M1 primary motor cortex for 20min with 35cm/2 electrode, Cathode (100cm/2) contralateral

sham tDCS

Intensive language therapy with Sham-tDCS

Group Type SHAM_COMPARATOR

Intensive language therapy

Intervention Type BEHAVIORAL

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

transcranial direct current stimulation

Intervention Type DEVICE

1mA anodal over M1 primary motor cortex for 20min with 35cm/2 electrode, Cathode (100cm/2) contralateral

Interventions

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Intensive language therapy

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

Intervention Type BEHAVIORAL

transcranial direct current stimulation

1mA anodal over M1 primary motor cortex for 20min with 35cm/2 electrode, Cathode (100cm/2) contralateral

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charité Neurocure AG Flöel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Agnes Floeel, Prof MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charite

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Robert Darkow

Role: CONTACT

004930450560395

Facility Contacts

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Robert Darkow

Role: primary

004930450560395

Other Identifiers

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CATS02EO0801

Identifier Type: -

Identifier Source: org_study_id

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