RecruitingNot ApplicableNCT05919485

The Effects of Specific tDCS on Cognition in MCI

The Effects of Specific Transcranial Direct Current Stimulation tDCS on Cognition in Mild Cognitive Impairment: A Novel Study Protocol

Sponsor

Istanbul Medipol University Hospital

Enrollment

120 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease Parkinson Disease

Summary

INTRODUCTION: Mild cognitive impairment (MCI) is a critical transitional stage in dementia related disorders. Dorsolateral prefrontal cortex (DLPFC), and the lateral parietal (LPC) cortex are subjected to neuropathological changes in MCI. Parietal memory network (PMN) integrity alterations and default mode network (DMN) alterations also occur in MCI. Transcranial direct current stimulation (tDCS) is a promising neuroprotective tool that modulates functional connectivity and might be useful to interfere with cognitive decline in relation to amnestic MCI (aMCI) and Parkinson's disease-MCI (PD-MCI) when applied to DLPFC and LPC. METHODS: This is a multicenter, randomized, and controlled study evaluating the effectiveness of anodal tDCS (atDCS ) applied bilaterally to the DLPFC/F3-F4 and LPC/ P3-P4 for 5 sessions with a total of 10 sessions in 14 days. The stimulation will be delivered with a 2 mA current frequency and will last 20 minutes a day for 5 days a week. The study consists of anodal, and sham control groups with a total of 120 participants with DLPFC and LPC anodal groups including 40 participants each and sham including 40 participants which are all between 45-80 years of age. At baseline and as an outcome measure, neurocognitive evaluation will be conducted using various tests standardized to use in the Turkish population. Functional magnetic resonance (fMRI) will be used to detect possible PMN and DMN alterations and hippocampal connectivity, and electroencephalogram (EEG) will be used to assess possible electrophysiological alterations that may happen as a result of atDCS. Baseline evaluation will be done before atDCS sessions and it will be repeated at the end of 14 days and 90 days. DISCUSSION: This study aims to explore the effectiveness of atDCS in PD-MCI, aMCI and to contribute to the literature in the field.

Eligibility

Min Age: 45 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) — which delivers a very mild electrical current to specific brain areas — can improve thinking and memory in people with Parkinson's disease or mild cognitive impairment (MCI). These are conditions where the brain's function starts to decline. **You may be eligible if:** - You are between 45 and 80 years old and able to read and write - You have been diagnosed with Parkinson's disease with mild cognitive impairment (PD-MCI), following established diagnostic criteria - OR you have been diagnosed with amnestic mild cognitive impairment (aMCI), a memory-focused type of early cognitive decline - You have been on a stable medication regimen for at least 1 month **You may NOT be eligible if:** - You are illiterate or have less than a primary school education - You have a neurological or psychiatric condition other than the qualifying diagnosis, or have had a head injury - You have irreversible hearing or vision problems, or other serious medical conditions like diabetes or uncontrolled high blood pressure - You show signs of full dementia (for the Parkinson's group) - You have any condition that prevents you from safely undergoing fMRI or tDCS Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREtDCS

0.06mA/cm2 from each electrode with total density of 0.054/cm2 for 20 minutes for 5 days a week, for 10 days and a total of 10 sessions in 14 days. Brain area; DLPFC / LPC