The Effects of Specific tDCS on Cognition in MCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorIstanbul Medipol University Hospital
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
tDCS
Procedure/Surgery0.06mA/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
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Interventional-DLPFCExperimental treatment 1 intervention
Group B: Interventional-LPCExperimental treatment 1 intervention
Group C: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neuropsychological Tests Scores
Moca, AdCom Scores
Time frame
Changes Before Treatment and 14 Days&90 Days after treatmentSecondary outcomes
1
EEG Power Spectrum Analysis
EEG data will be separated into one-second epochs after they are cleared of noise. Power spectrums of these data will be obtained in the delta, theta, alpha, beta and gamma frequency bands. Each epoch will be analyzed by Fast Fourier Transform (FFT, Fast Fourier Transform) with 10% Hanning window, then power spectrum analysis will be performed, giving the frequency values for each electrode by averaging all FFTs. Maximum peaks will be determined in the delta (0.5-3.5 Hz), theta (4-7 Hz), alpha (8-13 Hz), beta (15-28 Hz) and gamma (28-48 Hz) frequency bands. these values will be used in statistical analysis for each person and electrode.
Time frame
Changes Before Treatment and 14 Days after treatment2
EEG Coherence Analysis
Coherence measurements at delta, theta, alpha, beta and gamma frequencies can be analyzed for either intra-hemispheric electrode connections or inter-hemipheric electrode connections.Coherence values take values between 0-1. Values close to 0 indicate that there is no connection at the determined frequency between the two calculated electrode regions, while values close to 1 indicate a high coupling between the two electrode regions. Coherence values will be calculated with the Brain Vision Analyzer program using the formula below.The data obtained during memory and visualization will be separated into one-second epochs after they are cleared of noise.Power spectrums of these data will be obtained in the delta, theta, alpha, beta and gamma frequency bands. Each epoch will be analyzed by Fast Fourier Transform with 10% Hanning window.Then, these data will be calculated for all possible electrode pairs using the brain vision analysis program with the formula given below.
Time frame
Changes Before Treatment and 14 Days after treatment3
EEG functional connectivity analysis
eLORETA software will be used for functional connectivity analysis. sLORETA /eLORETA is an online free software developed by Roberto Pascual-Marqui and his team (http://www.uzh.ch/keyinst/loreta.htm). eLORETA is an algorithm developed to solve the inverse problem and it does not contain localization bias even in the presence of noise . In this software, resting state data with eyes closed, separated into 2 second epochs, whose artifacts are cleaned by preprocessing, will be used. The relevant areas to be analyzed in the cortical plane and the relevant frequency band gaps will be determined. The time series containing the eLORETA current source density obtained from these areas will be calculated and a "lagged linear coherence" matrix will be created to be applied in graph theory (Vecchio et al., 2014). "Lagged linear coherence" will give correct physiological connectivity unaffected by volume conduction and low spatial resolution.
Time frame
Changes Before Treatment and 14 Days after treatment4
Volumetric Magnetic resonance Imaging (MRI) and functional magnetic resonance imaging (rest-fMRI)
The change in central nervous system atrophy and resting state network activity between the groups.
Time frame
Changes Before Treatment and 14 Days after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istanbul Medipol University Hospital
Lead sponsor
Alanya Alaaddin Keykubat University
Collaborator
Source ClinicalTrials.gov