Effects of Non-invasive Neuromodulation on Food Desire, Chewing Pattern, Executive Functions and Oxidative Stress.

Not Applicable

Completed

• Conditions: Craving; Oxidative Stress; Mastication Disorder; Inflammation; Memory Disorders; Executive Dysfunction; Transcranial Direct Current Stimulation
• Interventions: Behavioral: speech therapy for chewing + real tDCS

• Registration Number: NCT05046145
• Lead Sponsor: Universidade Federal do Piauí

Brief Summary

From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information. Provoking changes in neuroplasticity and cortical excitability contribute to the regulation of neural activity. Both could be modified by applying direct electrical current to the sensorimotor cortex, with polarity/current-dependent results, and their effect would last for hours after the end of stimulation. Transcranial Direct Current Stimulation (tDCS), translated into Portuguese as Estimulação Transcraniana por Corrente Contínua (ETCC) is a neuromodulating tool in which a low-intensity electrical current is applied to the scalp to modulate neuronal activity.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-13
• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-16
• Status Verified: 2022-10
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• being a health professional at the HU-UFPI (higher and technical levels);
• both sexes;
• Age between 20 and 59 years old.

Exclusion Criteria

• Participants with communication disabilities (outbound or inbound);
• Type 1 and 2 diabetes
• low Body Mass Index (BMI; below 18.5),
• intracranial metal clip and/or prostheses;
• Abrupt change in weight (> 5 kg) in the last six months;
• the use will be excluded recreational use of psychoactive drugs,
• Being a smoker or using nicotine (tablet / absorbent),
• Having had significant recent trauma or traumatic brain injury,
• Present history of epilepsy,
• to be pregnant or under suspicion
• Missing teeth;
• Medical diagnosis of eating disorder or any psychiatric disorder,
• Having or having had cancer,
• Diagnosis of heart disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS + speech therapy+ sham	speech therapy for chewing + real tDCS	Participants will receive real tDCS and tDCS sham for 5 sessions during each treatment period. The interstice period of the total intervention will be 25 days, with 15 days of wash out between the two interventions. The probabilistic, simple randomized sample will consist of participants with food cravings randomized into two groups, according to the presence or absence of changes in eating behavior and within each group there will be subdivision to receive or not neuromodulation, according to the flowchart
sham + tDCS + speech therapy	speech therapy for chewing + real tDCS	Participants will receive real tDCS and tDCS sham for 5 sessions during each treatment period. The interstice period of the total intervention will be 25 days, with 15 days of wash out between the two interventions. The probabilistic, simple randomized sample will consist of participants with food cravings randomized into two groups, according to the presence or absence of changes in eating behavior and within each group there will be subdivision to receive or not neuromodulation, according to the flowchart

Primary Outcome Measures

Name	Time	Method
change in the executive brain functions - cognitive flexibility	post-intervention (immediately after the end of study participation).	Stroop Tests. Assessments with single measurements (measurement of time, in seconds, to perform the test).; the measurement unit for evaluating the outcome of these tests will be the amount of errors presented and the execution time (in seconds). The shorter the time and fewer errors, the better the result.
change in desire to consume food.	post-intervention (immediately after the end of study participation).	Questionnaires of Intense Food Desires - Trait (QDIC-T) validated for Brazilian Portuguese. The higher the score, the greater the amount of food craving presented. The QDIC-T scale is done on a 6-point scale with scores ranging from 39 to 214 points.
change in the executive brain functions - working memory	pre-intervention.	Trial Making Test (A and B). Assessments with single measurements (measurement of time, in seconds, to perform the test).; the measurement unit for evaluating the outcome of these tests will be the amount of errors presented and the execution time (in seconds). The shorter the time and fewer errors, the better the result.

Secondary Outcome Measures

Name	Time	Method
change in the final value of inflammation scores	post-intervention (immediately after the end of study participation).	inflammation markers (PCR in serum). The biochemical dosage of all elements will be in mg/L, higher values will represent a higher concentration, that is, a greater degree of inflammatory processes.
change in the final value of antioxidant activity	post-intervention (immediately after the end of study participation).	antioxidant activity (Catalase in erythrocytes). The biochemical dosage of all elements will be in mg/L, higher values will represent a higher concentration, that is, a greater degree of inflammatory processes.
change in desire to consume food.	post-intervention (immediately after the end of study participation).	Questionnaires of Intense Food Desires - State (QDIC-E); validated for Brazilian.Portuguese. The higher the score, the greater the amount of food craving presented. QDIC-E is made up of a five-point scale, ranging from 15 to 75 points.

Trial Locations

Locations (1)

Hospital Universitário Do Piauí; 🇧🇷 Teresina, Piaui, Brazil