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

Study Overview
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Brief Summary
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From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information.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.

Official Title
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Effects of Non-invasive Neuromodulation on Food Desire, Chewing Pattern, Executive Functions and Biochemical Markers of Inflammation and Oxidative Stress

Conditions
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Craving, Mastication Disorder, Memory Disorders, Executive Dysfunction, Transcranial Direct Current Stimulation, Inflammation, Oxidative Stress

Intervention / Treatment
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* Behavioral: speech therapy for chewing + real tDCS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be a randomized, double-blind, parallel clinical trial. Participants will receive real tDCS or tDCS sham for 10 sessions during the treatment period. The interstice period of the total intervention will be 15 days (2 subsequent weeks, 10 working days, to apply the intervention). The probabilistic, simple randomized sample will consist of participants with randomized food cravings into two groups, there will be subdivision to receive or not neuromodulation, according to the flowchart.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS + speech therapy+ sham<br>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 | Behavioral: speech therapy for chewing + real tDCS<br>* participants will be instructed to chew their food correctly during the tDCS session, but the participant does not know if the tdcs is real or sham.<br>* Other names: speech therapy for chewing + sham tDCS;|
| Experimental: sham + tDCS + speech therapy<br>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 | Behavioral: speech therapy for chewing + real tDCS<br>* participants will be instructed to chew their food correctly during the tDCS session, but the participant does not know if the tdcs is real or sham.<br>* Other names: speech therapy for chewing + sham tDCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in desire to consume food. | 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. | pre-intervention. | 
| change in desire to consume food. | 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. | post-intervention (immediately after the end of study participation). | 
| change in the executive brain functions - working memory | 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. | pre-intervention. | 
| change in the executive brain functions - cognitive flexibility | 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. | post-intervention (immediately after the end of study participation). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the final value of inflammation scores | 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. | pre-intervention. | 
| change in the final value of inflammation scores | 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. | post-intervention (immediately after the end of study participation). | 
| change in the final value of antioxidant activity | 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. | pre-intervention. | 
| change in the final value of antioxidant activity | 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. | post-intervention (immediately after the end of study participation). | 
| change in desire to consume food. | Questionnaires of Intense Food Desires - State (QDIC-E); validated for Brazilian Portuguese. QDIC-E is made up of a five-point scale, ranging from 15 to 75 points. The higher the score, the greater the amount of food craving presented. | pre-intervention. | 
| change in desire to consume food. | 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. | post-intervention (immediately after the end of study participation). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Craving, Executive Dysfunction, Oxidative Stress, Transcranial Direct Current Stimulation