NCT05919485Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 8 Jun 2023
- Start date
- 1 Aug 2023
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Istanbul Medipol University Hospital
- Diseases
- Alzheimer disease, Parkinson disease
- NCT number
- NCT05919485
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Aug 2023 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
Other illness
- Exhibiting signs of dementia for PD group ;
Other
- Illiterate or education level less than primary school
- Having medical issues that prevent undergoing fMRI or for tDCS application.
Who the study is looking for
- Providing an informed consent;
- Literate and between 45-80 years of age;
- 60 females and 60 males;
- 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;
- Diagnosed with aMCI based on diagnosis criteria (CDR\>0.5) suggested by Petersen;
- On a stable pharmacological treatment minimum for one month with no washout period.
Age in the registry: 45 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alanya Alaaddin Keykubat Üniversitesi Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.