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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
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mild Cognitive Impairment focused on measuring MCI, Word-retrieval, tDCS, fMRI

Eligibility Criteria

45 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 14, 2013
Last Updated
August 20, 2013
Sponsor
Charite University, Berlin, Germany
Collaborators
German Research Foundation
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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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