Clinical trial NCT05046145: 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
Overall status: COMPLETED
Phase: NA
Conditions: Craving
Mastication Disorder
Memory Disorders
Executive Dysfunction
Transcranial Direct Current Stimulation
Inflammation
Oxidative Stress
Keywords: Craving
Executive Dysfunction
Oxidative Stress
Transcranial Direct Current Stimulation
Lead sponsor: Universidade Federal do Piauí
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information.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


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.

Primary outcomes:
measure: change in desire to consume food.
timeFrame: pre-intervention.
measure: change in desire to consume food.
timeFrame: post-intervention (immediately after the end of study participation).
measure: change in the executive brain functions - working memory
timeFrame: pre-intervention.
measure: change in the executive brain functions - cognitive flexibility
timeFrame: post-intervention (immediately after the end of study participation).
Secondary outcomes:
measure: change in the final value of inflammation scores
timeFrame: pre-intervention.
measure: change in the final value of inflammation scores
timeFrame: post-intervention (immediately after the end of study participation).
measure: change in the final value of antioxidant activity
timeFrame: pre-intervention.
measure: change in the final value of antioxidant activity
timeFrame: post-intervention (immediately after the end of study participation).
measure: change in desire to consume food.
timeFrame: pre-intervention.
measure: change in desire to consume food.
timeFrame: post-intervention (immediately after the end of study participation).
Other outcomes:
Locations:
city: Teresina
country: Brazil
facility: Hospital Universitário Do Piauí
state: Piaui
Study officials:
References:
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citation: Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
citation: Kane MJ, Engle RW. Working-memory capacity and the control of attention: the contributions of goal neglect, response competition, and task set to Stroop interference. J Exp Psychol Gen. 2003 Mar;132(1):47-70. doi: 10.1037/0096-3445.132.1.47.
citation: Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
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