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CompletedNCT02110043Updated May 21, 2021

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

An interventional study of tDCS and training in Mild Cognitive Impairment (MCI), sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-05-21.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
01

Study 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.

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Conditions studied

  • Mild Cognitive Impairment (MCI)

Keywords

  • mild cognitive impairment (MCI)
  • tDCS
  • LOCATO task
  • visual-spatial learning
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In context

Cognitive Dysfunction

3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.

This study's enrollment of 21 is below the median of 64 across 2,855 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    training + tDCS

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

    Device: tDCS · Behavioral: training

  • Sham comparator
    training + sham stimulation

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

    Device: tDCS · Behavioral: training

Interventions

  • DevicetDCS

    transcranial direct current stimulation (tDCS)

  • Behavioraltraining

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: immediately after end of a 3-day period of training in tDCS condition vs sham condition

Secondary outcomes

  1. 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

    Time frame: after 1 month vs baseline

  2. functional changes: Connectivity

    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

  3. cortical excitability

    cortical excitability measured by transcranial magnetic stimulation (TMS)

    Time frame: at baseline

  4. 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)

    Time frame: after 1 month vs baseline

  5. 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

    Time frame: immediately after end of 3-day of cognitive training, after 1 month vs. baseline

  6. 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

    Time frame: immediately after the end of 3-day cognitive training, after 1 month vs. baseline

  7. 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).

    Time frame: once

07

Study locations

1 site
  • Charite Universitätsmedizin Berlin
    Berlin, 10117, Germany
08

References and documents

Publications

  • 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. PubMed 25176026 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02110043
Responsible party
Agnes Flöel (Prof. Dr., Charite University, Berlin, Germany) — Principal investigator
First posted
Apr 10, 2014
Start date
Mar 2014
Primary completion
Aug 2017
Completion
Oct 2017
Last update
May 21, 2021

Study contacts

Agnes Flöel, Prof. Dr.
principal investigator · Charite University, Berlin, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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