The Effects of Specific tDCS on Cognition in MCI

NCT05919485 | Recruiting

• 1 other identifier: 2023IMU_ALKU
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Parkinson Disease

Keywords

Mild cognitive impairment; Alzheimer's disease; Parkinson's disease; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Neuropsychological Tests Scores

  Moca, AdCom Scores

  Changes Before Treatment and 14 Days&90 Days after treatment

Secondary Outcomes (4)

• EEG Power Spectrum Analysis

  Changes Before Treatment and 14 Days after treatment

• EEG Coherence Analysis

  Changes Before Treatment and 14 Days after treatment

• EEG functional connectivity analysis

  Changes Before Treatment and 14 Days after treatment

• Volumetric Magnetic resonance Imaging (MRI) and functional magnetic resonance imaging (rest-fMRI)

  Changes Before Treatment and 14 Days after treatment

Study Arms (3)

Interventional-DLPFC

EXPERIMENTAL

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.

Procedure: tDCS

Interventional-LPC

EXPERIMENTAL

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.

Procedure: tDCS

Sham

SHAM COMPARATOR

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.

Procedure: tDCS

Interventions

tDCS PROCEDURE

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

Interventional-DLPFC; Interventional-LPC; Sham

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Providing an informed consent;
• Literate and between 45-80 years of age;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Alanya Alaaddin Keykubat University: collaborator

Study Sites (1)

Alanya Alaaddin Keykubat Üniversitesi

Antalya, Alanya, 33333, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Parkinson Disease; Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Cognition Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Burak Yuluğ, Prof. DR. MD

CONTACT

+90 242 510 6135; burakyulug@gmail.com

Cennet Sena Parlatan, PhD Cand

CONTACT

+90 507 779 91 64; cennetsenaparlatan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The distribution of the sham or real stimulators will be based on the random allocation which makes it impossible to identify the sham or real stimulation for the participants and the test instructors. This double-blind masking procedure will be applied all throughout the study steps in line with the reference study. The randomization data will be confidential and will not be accessible except for the medical emergencies. After the above-mentioned blinding process has been ended, the participants will be managed as off-study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. MD

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 26, 2023
• Study Start: August 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 15, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

TU (1)