Cognitive Ability Training for Seniors With Mild Cognitive Impairment

Study Overview
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Brief Summary
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This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation [tDCS]) during working memory training in seniors with mild cognitive impairments.The placebo-controlled double blinded study includes 50 elderly patients which will be randomized into verum or sham tDCS.

Detailed Description
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In this project, we want to test whether the effectiveness of neuropsychological exercise therapy can be increased in elderly persons suspected of having an MCI by means of parallel tDCS treatment. All test participants train over 6 sessions within 2 weeks two different working memory tasks with increasing difficulty. In the randomized, double-blind, prospective therapy study, participants are assigned to either a Verum-tDCS or a placebo-tDCS group. The Verum-tDCS group receives active stimulation in parallel to the exercise therapy, while the placebo group does not receive tDCS stimulation. To check the effects of the therapy, we measure performance and neuronal activation in different executive tasks using near-infrared spectroscopy (NIRS). Furthermore, we will check whether the training increases the volume of the grey matter (Draganski et al., 2004, Malchow et al., 2016) and the expression of BDNF can be increased (Schuch et al., 2015).

Official Title
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Verbesserung Kognitiver Fähigkeiten Bei Personen Mit Verdacht Auf Eine Leichte Kognitive Beeinträchtigung

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Device: Verum tDCS
* Device: Sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suspected MCI total CERAD score <= 85.1 MMSE >=24 native german speaker between 50-75 years old right handed Exclusion Criteria: impairment of daily living activities psychiatric, neurological diseases uncorrected hearing or vision deficits actual psychopharmaca intake metal parts in the head medical electronical implants

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum tDCS<br>prefrontal anodal stimulation | Device: Verum tDCS<br>* Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 2 mA<br>|
| Experimental: Sham tDCS<br>sham stimulation, same electrode positions | Device: Sham tDCS<br>* Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 0 mA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activation measured with NIRS | The Investigators are measuring brain activation during executive functions | 4 weeks | 
| Reaction times, errors and number of generated words in neuropsychological tasks | The Investigators are measuring cognitive performance for different executive functions | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T1 weighted magnetic resonance Imaging (MRI) of the brain | Structural changes in grey matter of the brain calculated by voxel based morphometry (VBM) | 4 weeks | 
| Blood sampling | Increased BDNF secretion in serum | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tDCS, MCI, Working Memory, fNIRS