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

October 31, 2022 updated by: Marta Maria da Silva Lira Batista, Universidade Federal do Piauí

Effects of Non-invasive Neuromodulation on Food Desire, Chewing Pattern, Executive Functions and Biochemical Markers of Inflammation 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From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information.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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Piaui
      • Teresina, Piaui, Brazil, 64056200
        • Hospital Universitário Do Piauí

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 57 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS + speech therapy+ sham
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
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
Experimental: sham + tDCS + speech therapy
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
pre-intervention.
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.
post-intervention (immediately after the end of study participation).
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.
pre-intervention.
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.
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
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.
pre-intervention.
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.
post-intervention (immediately after the end of study participation).
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.
pre-intervention.
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.
post-intervention (immediately after the end of study participation).
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.
pre-intervention.
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.
post-intervention (immediately after the end of study participation).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Piauí

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2021

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

August 13, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCSONCRAVINGFOOD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

THERE IS PREDICTION THAT THERE WILL BE UNDERLYING RESEARCH BASED ON THE RESULTS FOUND.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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