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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mild Cognitive Impairment (MCI)

Intervention / Treatment
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* Device: tDCS
* Behavioral: training


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: training + tDCS<br>Combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) | Device: tDCS<br>* transcranial direct current stimulation (tDCS)<br>Behavioral: training<br>* intensive training of visual-spatial abilities (in LOCATO task)<br>|
| Sham Comparator: training + sham stimulation<br>Combination of intensive training of visual-spatial abilities (LOCATO task) with sham stimulation | Device: tDCS<br>* transcranial direct current stimulation (tDCS)<br>Behavioral: training<br>* intensive training of visual-spatial abilities (in LOCATO task)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | immediately after end of a 3-day period of training in tDCS condition vs sham condition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | after 1 month vs baseline | 
| functional changes: Connectivity | Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of 3 day period of training | end of 3-day cognitive training vs baseline | 
| cortical excitability | cortical excitability measured by transcranial magnetic stimulation (TMS) | at baseline | 
| 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) | after 1 month vs baseline | 
| 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 | immediately after end of 3-day of cognitive training, after 1 month vs. baseline | 
| 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 | immediately after the end of 3-day cognitive training, after 1 month vs. baseline | 
| 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). | once | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild cognitive impairment (MCI), tDCS, LOCATO task, visual-spatial learning