Impact of Transcranial Direct Current Stimulation on Language Functions in Mild Cognitive Impairment (STIMCI)
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
tDCS
Sponsored by

About this trial
This is an interventional basic science trial for Mild Cognitive Impairment focused on measuring MCI, Word-retrieval, tDCS, fMRI
Eligibility 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
Sites / Locations
- Charite University Medicine, Department of Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
anodal tDCS
sham tDCS
Arm Description
anodal tDCS will be administered for 20 minutes with 1 milliampere (1 mA) to the left inferior frontal gyrus
sham tDCS will be administered to the left inferior frontal gyrus
Outcomes
Primary Outcome Measures
Number of correct responses during word-generation tasks (max. 60)
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)
Full Information
NCT ID
NCT01771211
First Posted
January 14, 2013
Last Updated
August 20, 2013
Sponsor
Charite University, Berlin, Germany
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01771211
Brief Title
Impact of Transcranial Direct Current Stimulation on Language Functions in Mild Cognitive Impairment
Acronym
STIMCI
Official Title
Impact of Transcranial Direct Current Stimulation on Language Functions in Mild Cognitive Impairment: A Proof-of-principle Study and Neural Correlates
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
MCI, Word-retrieval, tDCS, fMRI
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anodal tDCS
Arm Type
Experimental
Arm Description
anodal tDCS will be administered for 20 minutes with 1 milliampere (1 mA) to the left inferior frontal gyrus
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
sham tDCS will be administered to the left inferior frontal gyrus
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
DC-Stimulator Plus, neuroConn GmbH
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of correct responses during word-generation tasks (max. 60)
Description
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).
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Flöel, MD
Organizational Affiliation
Charite University Medicine, Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite University Medicine, Department of Neurology
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
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Impact of Transcranial Direct Current Stimulation on Language Functions in Mild Cognitive Impairment
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