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Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by tDCS

Primary Purpose

Mild Cognitive Impairment (MCI)

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
tDCS
training
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment (MCI) focused on measuring mild cognitive impairment (MCI), tDCS, LOCATO task, visual-spatial learning

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (MCI patients):

  • right handedness

  • amnestic and amnestic plus MCI with:

    1. subjective memory impairment;
    2. objective memory difficulties, at least 1 SD below gender, age and education adjusted standard values;
    3. relatively normal performance in other cognitive domains;
    4. no constraints in activities of daily livings
    5. age: 50-90 years

Exclusion Criteria:

  • severe internal or psychiatric disease
  • epilepsy
  • other severe neurological diseases, e.g. previous major stroke or brain tumor
  • DMS-IV manifest dementia
  • contraindication for MRT (claustrophobia, metallic implants, tattoos)

Sites / Locations

  • Charite Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

training + tDCS

training + sham stimulation

Arm Description

Combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS)

Combination of intensive training of visual-spatial abilities (LOCATO task) with sham stimulation

Outcomes

Primary Outcome Measures

Performance in LOCATO task (Visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS
Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to improvement of visual-spatial learning and memory measured by performance in LOCATO task after end of a 3 day period of training compared to sham stimulation.

Secondary Outcome Measures

long term effects
long term effects measured by performance in LOCATO task in tDCS condition after end of cognitve training and after 1 month compared to control conditions
functional changes: Connectivity
Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of 3 day period of training
cortical excitability
cortical excitability measured by transcranial magnetic stimulation (TMS)
Quality of Life
quality of life as measured by standardized questionaire at baseline compared to quality of life measured 1 month after intervention (training and stimulation vs. training and sham-stimualtion)
memory
memory performance tested at baseline compared to memory performance after the end of a 3-day cognitive training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation
affective state
affective state measured at baseline compared to affective state measured after the end of a 3-day cognitve training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation
genotyping of learning related polymorphisms
To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF Val66Met, COMT Val158Met).

Full Information

First Posted
February 13, 2014
Last Updated
May 20, 2021
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02110043
Brief Title
Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by tDCS
Official Title
Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement in learning and memory in patients with mild cognitive impairment (MCI) and to examine the underlying neuronal mechanism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment (MCI)
Keywords
mild cognitive impairment (MCI), tDCS, LOCATO task, visual-spatial learning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
training + tDCS
Arm Type
Experimental
Arm Description
Combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS)
Arm Title
training + sham stimulation
Arm Type
Sham Comparator
Arm Description
Combination of intensive training of visual-spatial abilities (LOCATO task) with sham stimulation
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
transcranial direct current stimulation (tDCS)
Intervention Type
Behavioral
Intervention Name(s)
training
Intervention Description
intensive training of visual-spatial abilities (in LOCATO task)
Primary Outcome Measure Information:
Title
Performance in LOCATO task (Visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS
Description
Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to improvement of visual-spatial learning and memory measured by performance in LOCATO task after end of a 3 day period of training compared to sham stimulation.
Time Frame
immediately after end of a 3-day period of training in tDCS condition vs sham condition
Secondary Outcome Measure Information:
Title
long term effects
Description
long term effects measured by performance in LOCATO task in tDCS condition after end of cognitve training and after 1 month compared to control conditions
Time Frame
after 1 month vs baseline
Title
functional changes: Connectivity
Description
Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of 3 day period of training
Time Frame
end of 3-day cognitive training vs baseline
Title
cortical excitability
Description
cortical excitability measured by transcranial magnetic stimulation (TMS)
Time Frame
at baseline
Title
Quality of Life
Description
quality of life as measured by standardized questionaire at baseline compared to quality of life measured 1 month after intervention (training and stimulation vs. training and sham-stimualtion)
Time Frame
after 1 month vs baseline
Title
memory
Description
memory performance tested at baseline compared to memory performance after the end of a 3-day cognitive training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation
Time Frame
immediately after end of 3-day of cognitive training, after 1 month vs. baseline
Title
affective state
Description
affective state measured at baseline compared to affective state measured after the end of a 3-day cognitve training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation
Time Frame
immediately after the end of 3-day cognitive training, after 1 month vs. baseline
Title
genotyping of learning related polymorphisms
Description
To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF Val66Met, COMT Val158Met).
Time Frame
once

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (MCI patients): right handedness amnestic and amnestic plus MCI with: subjective memory impairment; objective memory difficulties, at least 1 SD below gender, age and education adjusted standard values; relatively normal performance in other cognitive domains; no constraints in activities of daily livings age: 50-90 years Exclusion Criteria: severe internal or psychiatric disease epilepsy other severe neurological diseases, e.g. previous major stroke or brain tumor DMS-IV manifest dementia contraindication for MRT (claustrophobia, metallic implants, tattoos)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Flöel, Prof. Dr.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25176026
Citation
Kulzow N, Kerti L, Witte VA, Kopp U, Breitenstein C, Floel A. An object location memory paradigm for older adults with and without mild cognitive impairment. J Neurosci Methods. 2014 Nov 30;237:16-25. doi: 10.1016/j.jneumeth.2014.08.020. Epub 2014 Aug 28.
Results Reference
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Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by tDCS

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