MR Guided tDCS in Alzheimer's Disease

Study Overview
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Brief Summary
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The purpose of the study is to investigate the effect of High Density- tDCS (HD- tDCS) on cognitive function in Alzheimer's Disease. One anode and four return electrodes are placed over DLPFC, where low intensity current (2mA) is induced to the surface of the scalp. Electrode placement is individualized for each participant. Participants will undergo 15 stimulations, with a duration of 20 minutes each. All patients will undergo neuropsychological assessment and MRI evaluation.

Detailed Description
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The project will be run as a Randomized Controlled Trial (RCT), where patients will be randomized to receive either active anodal tDCS or sham tDCS. The performance on neuropsychological tests will be the primary outcome variables in the present project. In addition, whole brain MRI volume measures will be used to measure specific effects of tDCS treatment. Electrode placement is individualized for each participant with brain modeling techniques.

Official Title
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MR Guided tDCS: The Effect of Repeated Transcranial Direct Current Stimulation on Cognitive Functioning in Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Other: Anodal tDCS
* Other: Sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Alzheimer's Disease, mild and moderate stage Exclusion Criteria: Other neurological diseases or injuries Stroke Cancer Psychiatric disorders (moderate/ severe depression, psychosis)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS<br>Participants receive anodal tDCS over DLPFC. Each sessions lasts for 20 minutes, with a total of 15 stimulations: 6 acute sessions, 9 maintenance sessions. | Other: Anodal tDCS<br>* Anodal Transcranial direct current stimulation (tDCS) is a non- invasive brain stimulation technique. Low intensity current (1-2 mA) is induced to increase excitability, stimulate plasticity and enhance cognitive functions.<br>|
| Sham Comparator: Sham tDCS<br>Participants receive sham tDCS over DLPFC. Each sessions lasts for 20 minutes, with a total of 15 stimulations: 6 acute sessions, 9 maintenance sessions. | Other: Sham tDCS<br>* The electrodes are placed over the same areas as in the anodal tDCS condition. Participants will receive sham tDCS instead of anodal tDCS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on Neuropsychological tests | Compare scores before and after tDCS stimulation | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hippocampal volume | Compare performance on neuropsychological tests to hippocampal volume. Here we are looking at correlations between hippocampal thickness, performance on neuropsychological tests and effect of tDCS. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial direct current stimulation, Neuromodulation, Individualizing brain stimulation, Neuropsychology