Analysis of Inflammatory Predictors and Gene Expression in Patients With Mild Cognitive Impairment
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
A randomized, double-blind, placebo-controlled clinical trial will be conducted, using data from participants who met the diagnostic criteria for mild cognitive impairment and who participated in a primary clinical trial that investigated the effectiveness of treatment with tDCS for patients with this pathology. The study in question seeks to investigate differences in inflammatory profile and gene expression in peripheral blood of patients with MCI responders and non-responders to treatment with tDCS, where it is intended to establish a profile of biomarkers that can predict disease progression. Primary study participants will be assessed previously for eligibility, then randomized to receive sham or active tDCS. Then, they will be invited to participate in the prediction analysis study to identify the inflammatory profile and gene expression. The participants' venous blood will be collected during the clinical examination on the first day of treatment, before the first session of tDCS, with a new collection after the last session, that is, at the baseline and the end point of our study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedJune 22, 2021
February 1, 2021
2 months
February 9, 2021
June 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive Function
To assess the primary outcome, the Mini Mental State Examination (MMSE) or Mini-Mental State Examination (MMSE), developed in the United States and published in 1975, will be used, whose maximum score is 30 points and includes questions about memory, attention , orientation, language and visuospatial skills (Folstein, Folstein, \& McHugh, 1975). We will adopt the 24-point score for the standard cut, following recommendations expressed in the literature (Anthony, Le Resche, Niaz, Von Korff, \& Folstein, 1982; Folstein, Folstein, \& McHugh, 1975). In order to avoid false positives and false negatives, we will perform the stratification by levels or years of schooling, as educational level is the main predictor of MMSE performance (Bertolucci, Brucki, Campacci, \& Juliano, 1994).
Evaluations will be carried out in the pre-intervention (T0)
Secondary Outcomes (2)
Inflammatory biomarkers
The assessment will be carried out at time T1 (baseline).
Genetic Biomarkers
The assessment will be carried out at time T1 (baseline)
Study Arms (2)
active tDCS
EXPERIMENTALtDCS active, for 30 minutes for 5 consecutive days, with an anode positioned in the left dorsolateral prefrontal cortex and cathode electrode placed over the right supraorbital area. The EEG International 10-20 system will be taken as a reference. The current intensity will be defined from computational modeling, using Nuclear Magnetic Resonance (MRI) to estimate and individualize a dose to be administered.
Sham tDCS
SHAM COMPARATORThe electrodes will be positioned in the same way as in the intervention group. However, individuals in this group will receive a stimulation that will last only 20-30 seconds. Subsequently, the device is switched off, no longer emitting current.
Interventions
Eligibility Criteria
You may qualify if:
- Individuals diagnosed with CCL will be included
- Individuals of both sexes, aged 65 and over
- Individuals who do not have diagnosis of dementia
You may not qualify if:
- Subjects with unstable medical conditions
- Patients with metallic implants and pacemakers
- Epileptic patients
- Individuals using drugs / alcohol
- Those who are under regular use of hypnotics and benzodiazepines up to two weeks before the start of the study
- Those who are using medication with cholinergic inhibitors for more than two months before this clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The study design in question involves patients with MCI, submitted to an intervention protocol, which includes: G1) active vs. G2) tDCS sham. These participants will be assessed previously for eligibility, then randomized to receive tDCS sham or active. All researchers responsible for the evaluation before and after the interventions will be blinded to the type of treatment the patient will receive (active stimulation or sham). The effectiveness of the masking mechanism will be assessed at the time of the last interview with patients when they will be asked about their opinion as to whether the electric current producing system was on or off.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Researcher and Professor
Study Record Dates
First Submitted
February 9, 2021
First Posted
June 22, 2021
Study Start
June 1, 2021
Primary Completion
August 1, 2021
Study Completion
April 1, 2022
Last Updated
June 22, 2021
Record last verified: 2021-02