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

Primary Purpose

Craving, Mastication Disorder, Memory Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
speech therapy for chewing + real tDCS
Sponsored by
Universidade Federal do Piauí
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craving focused on measuring Craving, Executive Dysfunction, Oxidative Stress, Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Universitário Do Piauí

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

tDCS + speech therapy+ sham

sham + tDCS + speech therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 13, 2021
Last Updated
October 31, 2022
Sponsor
Universidade Federal do Piauí
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1. Study Identification

Unique Protocol Identification Number
NCT05046145
Brief Title
Effects of Non-invasive Neuromodulation on Food Desire, Chewing Pattern, Executive Functions and Oxidative Stress.
Official Title
Effects of Non-invasive Neuromodulation on Food Desire, Chewing Pattern, Executive Functions and Biochemical Markers of Inflammation and Oxidative Stress
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Piauí

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craving, Mastication Disorder, Memory Disorders, Executive Dysfunction, Transcranial Direct Current Stimulation, Inflammation, Oxidative Stress
Keywords
Craving, Executive Dysfunction, Oxidative Stress, Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Participants do not know what treatment they will receive. The outcomes assessor does not know treatment aplicado in participants sham or real).
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS + speech therapy+ sham
Arm Type
Experimental
Arm Description
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
Arm Title
sham + tDCS + speech therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
speech therapy for chewing + real tDCS
Other Intervention Name(s)
speech therapy for chewing + sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in desire to consume food.
Description
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.
Time Frame
pre-intervention.
Title
change in desire to consume food.
Description
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.
Time Frame
post-intervention (immediately after the end of study participation).
Title
change in the executive brain functions - working memory
Description
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.
Time Frame
pre-intervention.
Title
change in the executive brain functions - cognitive flexibility
Description
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.
Time Frame
post-intervention (immediately after the end of study participation).
Secondary Outcome Measure Information:
Title
change in the final value of inflammation scores
Description
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.
Time Frame
pre-intervention.
Title
change in the final value of inflammation scores
Description
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.
Time Frame
post-intervention (immediately after the end of study participation).
Title
change in the final value of antioxidant activity
Description
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.
Time Frame
pre-intervention.
Title
change in the final value of antioxidant activity
Description
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.
Time Frame
post-intervention (immediately after the end of study participation).
Title
change in desire to consume food.
Description
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.
Time Frame
pre-intervention.
Title
change in desire to consume food.
Description
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.
Time Frame
post-intervention (immediately after the end of study participation).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Universitário Do Piauí
City
Teresina
State/Province
Piaui
ZIP/Postal Code
64056200
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
THERE IS PREDICTION THAT THERE WILL BE UNDERLYING RESEARCH BASED ON THE RESULTS FOUND.
Citations:
PubMed Identifier
27498606
Citation
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Results Reference
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Links:
URL
https://pubmed.ncbi.nlm.nih.gov/27498606/
Description
Ljubisavljevic M, Maxood K, Bjekic J, Oommen J, Nagelkerke N.
URL
https://pubmed.ncbi.nlm.nih.gov/28479407/
Description
Martin AA, Davidson TL, McCrory MA

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

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