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Completed

NCT Number: NCT02110043

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

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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite Universitätsmedizin Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

tDCS

Device

transcranial direct current stimulation (tDCS)

Training

Behavioral

intensive training of visual-spatial abilities (in LOCATO task)

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. cortical excitability

    Time frame: at baseline

    cortical excitability measured by transcranial magnetic stimulation (TMS)

  4. 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)

  5. 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

  6. 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

  7. 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).

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 10, 2014
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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