Study of Neurobiological Predictors of Response to Non-invasive Neurostimulation and Genetic Susceptibility to Dementia in Patients With Amnestic Mild Cognitive Impairment

NCT ID: NCT04943003

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-26
• Study Completion Date: 2024-12-25

Brief Summary

Transcranial Direct Current Stimulation is a non-invasive neuromodulatory technique that results in the clinical improvement of patients with Mild Cognitive Impairment, a prodromal condition for the onset of dementia. The responses to treatment depend on the characteristics of the patients and the parameters adjusted in the equipment, which makes the modeling of electric fields imperative to maximize the safety profile and therapeutic potential of the technique. The study of neurobiological predictors of response to non-invasive neurostimulation and genetic susceptibility can elucidate current effects according to the individual's profile. The objectives of this study are to observe the effects of Transcranial Direct Current Stimulation with optimized/customized parameters in patients with amnestic CCL, considering the subjects' genetic susceptibility to Alzheimer's Disease and neurobiological markers. This is a randomized, triple-blind, sham-controlled clinical trial. Neuropsychological tests and a sociodemographic and clinical questionnaire will be used to assess and characterize the subjects. Participants captured by the Laboratory of Studies in Aging and Neuroscience at the Federal University of Paraíba will be divided into 02 groups, each with 25 patients, totaling 50 volunteers: Active - participants who will receive real current; Sham - participants who will receive simulated stimulation. Participants entered through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1. Payment parameters will be customized by Computational Modeling with the aid of the SimNIBS Program and Nuclear Magnetic Resonance. The electroencephalogram and evaluation of polymorphisms of the gene encoding Apolipoprotein E examined as predictors of response. Data will be processed from the Statistical Package for Social Sciences® (20.0) Software, applying the Student test for continuous variables or chi-square for categorical variables. Predictive analysis will be conducted from Machine Learning. It is expected to find improvements in the scores of memory and general cognition tests after the intervention protocol with tDCS with individualized dose in the group that will receive an intervention, compared to the simulated neurostimulation group. These obtained results optimize the practice, elucidating issues still present due to the different applications of the technique produced in the literature on the subject.

Detailed Description

Neuropsychological tests and a sociodemographic and clinical questionnaire will be used to assess and characterize the subjects. Participants captured by the Laboratory of Studies in Aging and Neuroscience at the Federal University of Paraíba will be divided into 02 groups, each with 25 patients, totaling 50 volunteers: Active - participants who will receive real current; Sham - participants who will receive simulated stimulation. Participants entered through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1. Payment parameters will be customized by Computational Modeling with the aid of the SimNIBS Program and Nuclear Magnetic Resonance. The electroencephalogram and evaluation of polymorphisms of the gene encoding Apolipoprotein E examined as predictors of response.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active tDCS

SimNIBS will be used for modeling. It is a free and open source software package for the simulation of electric field induced by tDCS in the individual brain.

Modeling will be done using T1-weighted anatomical images of each subject to reconstruct a high-resolution head model of each individual. For electrode placement, we will simulate areas F5 and F6, according to the EEG 10-20 system, for the anode and cathode, respectively, targeting the left and right Dorsolateral Prefrontal Cortex (DLPFC). This group will receive active tDCS, for 30 minutes and for 5 consecutive days, in two weeks, with an anode positioned on the left DLPFC and a cathode electrode placed on the right supraorbital area.

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Initially, a measuring tape will be used to make the markings and measurements necessary for placing the electrodes.

Regarding neurostimulation, the tDCS device is simple and portable, consisting of four main components: two electrodes (anode and cathode), an ammeter (electric current intensity meter), a potentiometer (voltage controller between electrodes) and a set of batteries. We will use the TCT-Research Neurostimulator, developed by Trans Cranial Technologies (Hong Kong, China), Regarding the protocols, the Active tDCS group will receive active tDCS for 30 minutes and for 5 consecutive days, in two weeks, with an anode positioned on the left DLPFC and a cathode electrode placed on the right supraorbital area. The 10-20 International EEG system will be taken as a reference. The current intensity will be defined from computational modeling, using Nuclear Magnetic Resonance (NMR) to estimate and individualize the dose to be administered.

Sham tDCS

The electrodes will be placed in the same way as in the Active tDCS group. However, individuals in this group will receive a stimulation that will last only 20-30 seconds. Afterwards, the device will be turned off, no longer emitting current.

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

Initially, a measuring tape will be used to make the markings and measurements necessary for placing the electrodes.

Regarding neurostimulation, the tDCS device is simple and portable, consisting of four main components: two electrodes (anode and cathode), an ammeter (electric current intensity meter), a potentiometer (voltage controller between electrodes) and a set of batteries. We will use the TCT-Research Neurostimulator, developed by Trans Cranial Technologies (Hong Kong, China), Regarding the protocols, the Active tDCS group will receive active tDCS for 30 minutes and for 5 consecutive days, in two weeks, with an anode positioned on the left DLPFC and a cathode electrode placed on the right supraorbital area. The 10-20 International EEG system will be taken as a reference. The current intensity will be defined from computational modeling, using Nuclear Magnetic Resonance (NMR) to estimate and individualize the dose to be administered.

Interventions

Transcranial Direct Current Stimulation (tDCS)

Initially, a measuring tape will be used to make the markings and measurements necessary for placing the electrodes.

Regarding neurostimulation, the tDCS device is simple and portable, consisting of four main components: two electrodes (anode and cathode), an ammeter (electric current intensity meter), a potentiometer (voltage controller between electrodes) and a set of batteries. We will use the TCT-Research Neurostimulator, developed by Trans Cranial Technologies (Hong Kong, China), Regarding the protocols, the Active tDCS group will receive active tDCS for 30 minutes and for 5 consecutive days, in two weeks, with an anode positioned on the left DLPFC and a cathode electrode placed on the right supraorbital area. The 10-20 International EEG system will be taken as a reference. The current intensity will be defined from computational modeling, using Nuclear Magnetic Resonance (NMR) to estimate and individualize the dose to be administered.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Individuals diagnosed with Mild Cognitive Impairment (MCI);
• Both sexes;
• Aged 65 years or older, without a diagnosis of dementia will be included.

Exclusion Criteria

• Unstable medical conditions;
• Patients with metallic implants and pacemakers;
• Epileptics;
• Using drugs/alcohol, regular use of hypnotics and benzodiazepines up to two weeks before the start of the study;
• People who have been using medication with cholinergic inhibitors for more than two months before this clinical trial

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suellen Marinho Andrade

OTHER

Sponsor Role: lead

Responsible Party

Suellen Marinho Andrade

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Federal University of Paraíba,Department of Psychology

João Pessoa, Paraíba, Brazil

Countries

Brazil

Other Identifiers

tDCS in MCI

Identifier Type: -

Identifier Source: org_study_id