Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia

NCT ID: NCT01845129

Last Updated: 2013-05-03

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

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-04-30

Brief Summary

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The present study assesses whether language functions in patients with residual post-stroke aphasia can be improved by transcranial direct current stimulation administered to the primary motor cortex in the language dominant (left) hemisphere.

Detailed Description

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Patients will participate in two tDCS sessions (atDCS; sham) in a cross-over within subjects design. tDCS or placebo will be administered during simulatneous fMRI to assess neural signatures of the stimulation. Order of stimulation will be counterbalanced between subjects

Conditions

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Residual Aphasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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anodal tDCS

atDCS will be administered for 20 minutes with 1 milliampere (1 mA) to the left primary hand motor cortex

Group Type EXPERIMENTAL

atDCS

Intervention Type DEVICE

atDCS will be delivered with a constant current of 1 mA during simultaneous resting-state (RS) and task-related (picture naming) functional magnetic resonance imaging (fMRI). The current will be turned on prior to the RS-fMRI scan and continues for 20 minutes.

sham tDCS

Intervention Type DEVICE

During sham the current will be increeased and decreased in a ramp-like fashion (10 sec)

sham tDCS

sham tDCS will be administered to the left primary hand motor cortex

Group Type SHAM_COMPARATOR

atDCS

Intervention Type DEVICE

atDCS will be delivered with a constant current of 1 mA during simultaneous resting-state (RS) and task-related (picture naming) functional magnetic resonance imaging (fMRI). The current will be turned on prior to the RS-fMRI scan and continues for 20 minutes.

sham tDCS

Intervention Type DEVICE

During sham the current will be increeased and decreased in a ramp-like fashion (10 sec)

Interventions

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atDCS

atDCS will be delivered with a constant current of 1 mA during simultaneous resting-state (RS) and task-related (picture naming) functional magnetic resonance imaging (fMRI). The current will be turned on prior to the RS-fMRI scan and continues for 20 minutes.

Intervention Type DEVICE

sham tDCS

During sham the current will be increeased and decreased in a ramp-like fashion (10 sec)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* right handedness
* German native speaker
* cerebrovascular stroke in left hemisphere (\>6 months)
* mild aphasia (according to Aachen Aphasia Test Battery Classification, Huber et al., 1983)
* residual anomia in naming test (\>75 correct responses)

Exclusion Criteria

* other current or previous neurological or psychiatric diseases
* alcohol or drug abuse
* MRI contraindication (e.g. magnetic metal, pacemaker, claustrophobia)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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: PRINCIPAL_INVESTIGATOR

Charite, University Medicine, Neurology

Locations

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Charite, University Medicine, Dept. of Neurology

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Robert Darkow, MSc

Role: CONTACT

+49 30 450 560 ext. 395

Facility Contacts

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Robert Darkow, MSc

Role: primary

+49 30 450 560 ext. 395

Other Identifiers

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RAPH_01EO0801

Identifier Type: -

Identifier Source: org_study_id

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