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

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Marcus Meinzer, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01771211
First received: January 14, 2013
Last updated: August 20, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   45 Years to 86 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Marcus Meinzer, Creutzfeld Fellow, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01771211     History of Changes
Other Study ID Numbers: FL379101
Study First Received: January 14, 2013
Last Updated: August 20, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 27, 2014