Clinical trial NCT04943003: Study of Neurobiological Predictors of Response to Non-invasive Neurostimulation and Genetic Susceptibility to Dementia in Patients With Amnestic Mild Cognitive Impairment
Official title: Neurobiological Predictors of Response to Non-invasive Neurostimulation and Genetic Susceptibility to Dementia in Patients With Amnestic Mild Cognitive Impairment (CCL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
tDCS
Computational modeling
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants 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 into the study through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mini Mental State Examination (MMSE) (T0)
timeFrame: The evoluations will be carried out in Pre-intervention (T0)
measure: Mini Mental State Examination (MMSE) (T1)
timeFrame: The evoluations will be performed up to one week after the stimulation protocol (T1)
Secondary outcomes:
measure: Digit Span Memory Test
timeFrame: The evoluations will be carried out in Pre-intervention (T0)
measure: Digit Span Memory Test
timeFrame: The evoluations will be performed up to one week after the stimulation protocol (T1)
measure: Beck Depression Scale II and Beck Anxiety Inventory
timeFrame: The evoluations will be carried out in Pre-intervention (T0)
measure: Beck Depression Scale II and Beck Anxiety Inventory
timeFrame: The evoluations will be performed up to one week after the stimulation protocol (T1)
measure: Genetic susceptibility (ApoE)
timeFrame: The evoluations will be carried out in Pre-intervention (T0)
measure: Electroencephalography
timeFrame: The evoluations will be carried out in Pre-intervention (T0)
measure: Electroencephalography (EEG)
timeFrame: The evoluations will be performed up to one week after the stimulation protocol (T1)
measure: Magnetic Resonance Imaging-MRI
timeFrame: The evoluations will be carried out in Pre-intervention (T0)
measure: Magnetic Resonance Imaging-MRI
timeFrame: The evoluations will be performed up to one week after the stimulation protocol (T1)
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Federal University of Paraíba,Department of Psychology
state: Paraíba
Study officials:
References: