Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Providing an willing to sign a consent form; 2. Literate and between 45-80 years of age; 3. 60 females and 60 males; 4. Diagnosed with PD based on criteria suggested by UK Parkinson's Disease Society, Brain Bank and PD-MCI in accordance with the diagnostic criteria suggestions by Litvan; 5. Diagnosed with aMCI based on diagnosis criteria (CDR\>0.5) suggested by Petersen; 6. On a stable pharmacological treatment minimum for one month with no waiting period after previous treatment. Who Should NOT Join This Trial: - Illiterate or education level less than primary school - Having an existing and/or prior neurological disease; psychiatric disease or head trauma; and/or irreversible hearing or sight problems or other medical illness (e.g. diabetes mellitus, hypertension); - Exhibiting signs of dementia for PD group ; - Having medical issues that prevent undergoing fMRI or for tDCS application. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Providing an informed consent; 2. Literate and between 45-80 years of age; 3. 60 females and 60 males; 4. Diagnosed with PD based on criteria suggested by UK Parkinson's Disease Society, Brain Bank and PD-MCI in accordance with the diagnostic criteria suggestions by Litvan; 5. Diagnosed with aMCI based on diagnosis criteria (CDR\>0.5) suggested by Petersen; 6. On a stable pharmacological treatment minimum for one month with no washout period. Exclusion Criteria: * Illiterate or education level less than primary school * Having an existing and/or prior neurological disease; psychiatric disease or head trauma; and/or irreversible hearing or sight problems or other medical illness (e.g. diabetes mellitus, hypertension); * Exhibiting signs of dementia for PD group ; * Having medical issues that prevent undergoing fMRI or for tDCS application.

Treatments Being Tested

PROCEDURE

tDCS

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

Locations (1)

Alanya Alaaddin Keykubat Üniversitesi
Antalya, Alanya, Turkey (Türkiye)