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Completed

NCT Number: NCT05046145

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

From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information.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

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Key information

Conditions

Craving Executive Dysfunction Inflammation Mastication Disorder Memory Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Oxidative Stress Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Transcranial Direct Current Stimulation

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitário Do Piauí

Teresina, Piauí, 64056200, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

speech therapy for chewing + real tDCS

Behavioral

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.

Other names: speech therapy for chewing + sham tDCS

Primary outcomes

  1. change in desire to consume food.

    Time frame: pre-intervention.

    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.

  2. change in desire to consume food.

    Time frame: 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.

  3. change in the executive brain functions - working memory

    Time frame: 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.

  4. change in the executive brain functions - cognitive flexibility

    Time frame: 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.

Secondary outcomes

  1. change in the final value of inflammation scores

    Time frame: pre-intervention.

    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.

  2. change in the final value of inflammation scores

    Time frame: 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.

  3. change in the final value of antioxidant activity

    Time frame: pre-intervention.

    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.

  4. change in the final value of antioxidant activity

    Time frame: 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.

  5. change in desire to consume food.

    Time frame: pre-intervention.

    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.

  6. change in desire to consume food.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Piauí

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2021
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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