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Impact of Transcranial Direct Current Stimulation on Language Functions in Mild Cognitive Impairment

NCT ID: NCT01771211

Last Updated: 2013-08-22

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

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-07-31

Brief Summary

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The purpose of this study is to determine if non-invasive electrical brain stimulation can improve word-retrieval in Mild Cognitive Impairment (MCI).

Detailed Description

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Previous studies showed that anodal transcranial direct current stimulation (atDCS) can have beneficial effects on word-retrieval in healthy younger and older subjects. The present study aims to extend these findings by assessing whether atDCS can also improve known impairments of word-retrieval in Mild Cognitive Impairment. atDCS will be applied to the left inferior frontal gyrus in a sham controlled cross-over within subjects design. Simultaneous functional magnetic resonance imaging (fMRI) will assess underlying neural effects of the stimulation.

Conditions

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Mild Cognitive Impairment

Keywords

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MCI Word-retrieval tDCS fMRI

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

anodal tDCS will be administered for 20 minutes with 1 milliampere (1 mA) to the left inferior frontal gyrus

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

anodal tDCS will be delivered with a constant current of 1 mA during resting-state and task-related fMRI and will continue until the end of the word-generation task. For both stimulation conditions (atDCS, sham) the current will be initially increased in a ramp-like fashion over 10 s, eliciting a tingling sensation on the scalp that fades over seconds. During sham stimulation the current will be turned off after 30 s.

sham tDCS

sham tDCS will be administered to the left inferior frontal gyrus

Group Type SHAM_COMPARATOR

tDCS

Intervention Type DEVICE

anodal tDCS will be delivered with a constant current of 1 mA during resting-state and task-related fMRI and will continue until the end of the word-generation task. For both stimulation conditions (atDCS, sham) the current will be initially increased in a ramp-like fashion over 10 s, eliciting a tingling sensation on the scalp that fades over seconds. During sham stimulation the current will be turned off after 30 s.

Interventions

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tDCS

anodal tDCS will be delivered with a constant current of 1 mA during resting-state and task-related fMRI and will continue until the end of the word-generation task. For both stimulation conditions (atDCS, sham) the current will be initially increased in a ramp-like fashion over 10 s, eliciting a tingling sensation on the scalp that fades over seconds. During sham stimulation the current will be turned off after 30 s.

Intervention Type DEVICE

Other Intervention Names

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DC-Stimulator Plus, neuroConn GmbH

Eligibility Criteria

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Inclusion Criteria

* right handed
* German native speakers
* clinical diagnosis of Mild Cognitive Impairment

Exclusion Criteria

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

45 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Marcus Meinzer

Creutzfeld Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Agnes Flöel, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University Medicine, Department of Neurology

Locations

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Charite University Medicine, Department of Neurology

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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FL379101

Identifier Type: -

Identifier Source: org_study_id