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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02110043
First Posted: April 10, 2014
Last Update Posted: July 27, 2017
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.
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
  Purpose
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.

Condition Intervention
Mild Cognitive Impairment (MCI) Device: tDCS Behavioral: training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms

Further study details as provided by Agnes Flöel, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Performance in LOCATO task (Visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS [ Time Frame: immediately after end of a 3-day period of training in tDCS condition vs sham condition ]
    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 [ Time Frame: after 1 month vs baseline ]
    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 [ Time Frame: end of 3-day cognitive training vs baseline ]
    Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of 3 day period of training

  • cortical excitability [ Time Frame: at baseline ]
    cortical excitability measured by transcranial magnetic stimulation (TMS)

  • Quality of Life [ Time Frame: after 1 month vs baseline ]
    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 [ Time Frame: immediately after end of 3-day of cognitive training, after 1 month vs. baseline ]
    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 [ Time Frame: immediately after the end of 3-day cognitive training, after 1 month vs. baseline ]
    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 [ Time Frame: once ]
    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).


Enrollment: 21
Study Start Date: March 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: training + tDCS
Combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS)
Device: tDCS
transcranial direct current stimulation (tDCS)
Behavioral: training
intensive training of visual-spatial abilities (in LOCATO task)
Sham Comparator: training + sham stimulation
Combination of intensive training of visual-spatial abilities (LOCATO task) with sham stimulation
Device: tDCS
transcranial direct current stimulation (tDCS)
Behavioral: training
intensive training of visual-spatial abilities (in LOCATO task)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  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): NCT02110043


Locations
Germany
Charite Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Agnes Flöel, Prof. Dr. Charite University, Berlin, Germany
  More Information

Publications:
Responsible Party: Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02110043     History of Changes
Other Study ID Numbers: LOCATO-MCI-tDCS
First Submitted: February 13, 2014
First Posted: April 10, 2014
Last Update Posted: July 27, 2017
Last Verified: July 2017

Keywords provided by Agnes Flöel, Charite University, Berlin, Germany:
mild cognitive impairment (MCI)
tDCS
LOCATO task
visual-spatial learning

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