Actively Recruiting

Phase Not Applicable
Age: 45Years - 80Years
All Genders
NCT05919485

The Effects of Specific tDCS on Cognition in MCI

Led by Istanbul Medipol University Hospital · Updated on 2025-05-02

120

Participants Needed

1

Research Sites

123 weeks

Total Duration

On this page

Sponsors

I

Istanbul Medipol University Hospital

Lead Sponsor

A

Alanya Alaaddin Keykubat University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Effects of Specific tDCS on Cognition in MCI

Who Can Participate

Age: 45Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide informed consent
  • Be literate and between 45 and 80 years old
  • Include 60 females and 60 males in total
  • Diagnosed with Parkinson's disease based on UK Parkinson's Disease Society Brain Bank criteria and Litvan's PD-MCI criteria
  • Diagnosed with amnestic mild cognitive impairment (aMCI) according to Petersen's criteria (CDR > 0.5)
  • On stable pharmacological treatment for at least one month with no washout period
Not Eligible

You will not qualify if you...

  • Illiterate or education level below primary school
  • Have existing or prior neurological disease, psychiatric disease, head trauma, irreversible hearing or sight problems, or other medical illnesses such as diabetes mellitus or hypertension
  • Show signs of dementia in the Parkinson's disease group
  • Have medical conditions that prevent undergoing fMRI or tDCS application

AI-Screening

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Trial Site Locations

Total: 1 location

1

Alanya Alaaddin Keykubat Üniversitesi

Antalya, Alanya, Turkey (Türkiye), 33333

Actively Recruiting

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Research Team

B

Burak Yuluğ, Prof. DR. MD

CONTACT

C

Cennet Sena Parlatan, PhD Cand

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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