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Completed

NCT Number: NCT01771211

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

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

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

45 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite University Medicine, Department of Neurology

Berlin, State of Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

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.

Other names: DC-Stimulator Plus, neuroConn GmbH

Primary outcomes

  1. Number of correct responses during word-generation tasks (max. 60)

    Time frame: Change in number of correct responses between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week

    Subjects are assessed in a cross-over design. The primary outcome measure will be assessed twice in each subject, either during sham stimulation or active stimulation with transcranial direct current stimulation. Order of stimulation (sham, atDCS or atDCS, sham) will be counterbalanced across the group. The study design has been described in detail before (Meinzer et al., 2012, Journal of Neuroscience, 32:1859 -1866).

Secondary outcomes

  1. Neural activity during word-generation task assessed by functional magnetic resonance imaging (fMRI)

    Time frame: Change in fMRI activity between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

Impact of Transcranial Direct Current Stimulation on Language Functions in Mild Cognitive Impairment: A Proof-of-principle Study and Neural Correlates

Acronym: STIMCI

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 18, 2013
Registry last updated
Aug 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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