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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01771211
First Posted: January 18, 2013
Last Update Posted: August 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Marcus Meinzer, Charite University, Berlin, Germany
  Purpose
The purpose of this study is to determine if non-invasive electrical brain stimulation can improve word-retrieval in Mild Cognitive Impairment (MCI).

Condition Intervention
Mild Cognitive Impairment Device: tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Impact of Transcranial Direct Current Stimulation on Language Functions in Mild Cognitive Impairment: A Proof-of-principle Study and Neural Correlates

Further study details as provided by Marcus Meinzer, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: December 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anodal tDCS
anodal tDCS will be administered for 20 minutes with 1 milliampere (1 mA) to the left inferior frontal gyrus
Device: 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.
Other Name: DC-Stimulator Plus, neuroConn GmbH
Sham Comparator: sham tDCS
sham tDCS will be administered to the left inferior frontal gyrus
Device: 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.
Other Name: DC-Stimulator Plus, neuroConn GmbH

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 86 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771211


Locations
Germany
Charite University Medicine, Department of Neurology
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation
Investigators
Principal Investigator: Agnes Flöel, MD Charite University Medicine, Department of Neurology
  More Information

Responsible Party: Marcus Meinzer, Creutzfeld Fellow, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01771211     History of Changes
Other Study ID Numbers: FL379101
First Submitted: January 14, 2013
First Posted: January 18, 2013
Last Update Posted: August 22, 2013
Last Verified: August 2013

Keywords provided by Marcus Meinzer, Charite University, Berlin, Germany:
MCI
Word-retrieval
tDCS
fMRI

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders