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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05046145
Enrollment
36
Registered
2021-09-16
Start date
2021-07-13
Completion date
2022-10-31
Last updated
2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Craving, Executive Dysfunction, Oxidative Stress, Transcranial Direct Current Stimulation

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From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information.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

Interventions

BEHAVIORALspeech 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.

Sponsors

Universidade Federal do Piauí
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes 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).

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
change in desire to consume food.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.
change in the executive brain functions - working memorypre-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.
change in the executive brain functions - cognitive flexibilitypost-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

MeasureTime frameDescription
change in the final value of inflammation scorespre-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.
change in the final value of antioxidant activitypre-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.
change in desire to consume food.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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026