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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Alanya Alaaddin Keykubat Üniversitesi
RECRUITING
Antalya
Contact Information
Primary
Burak Yuluğ, Prof. DR. MD
burakyulug@gmail.com
+90 242 510 6135
Backup
Cennet Sena Parlatan, PhD Cand
cennetsenaparlatan@gmail.com
+90 507 779 91 64
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 120
Treatments
Experimental: Interventional-DLPFC
DLPC/F3-F4 group will consist of 20 PD-MCI patients and 20 aMCI patients; 2mA anodal tDCS over DLPFC The current density will be 0.06mA/cm2 from each electrode with total density of 0.054/cm2 and will be delivered for 20 minutes for the atDCS group for 5 days a week, for 10 days and a total of 10 sessions in 14 days.
Experimental: Interventional-LPC
LPC/P3-P4 group will consist of 20 PD-MCI patients and 20 aMCI patients; 2mA anodal tDCS over LPC The current density will be 0.06mA/cm2 from each electrode with total density of 0.054/cm2 and will be delivered for 20 minutes for the atDCS group for 5 days a week, for 10 days and a total of 10 sessions in 14 days.
Sham_comparator: Sham
Sham control group will consist of 40 patients (20 aMCI and 20 PD-MCI patients).~2mA anodal sham tDCS protocol. For the sham protocol, the stimulation will be delivered for one time with a very low current frequency, enough to cause slight tingling, and for 15 seconds long which will also be delivered for 20 minutes, 5 days a week, for 10 days and a total of 10 sessions in 14 days.
Sponsors
Leads: Istanbul Medipol University Hospital
Collaborators: Alanya Alaaddin Keykubat University

This content was sourced from clinicaltrials.gov