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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05046145
• Other study ID #: tDCSONCRAVINGFOOD
• Status: Completed
• Phase: N/A
• Start date: July 13, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2022
• Source: Universidade Federal do Piauí
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Universitário Do Piauí	Teresina	Piaui

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Piauí

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

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. Review. — View Citation

Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27. Review. — View Citation

Diamond A. Executive functions. Handb Clin Neurol. 2020;173:225-240. doi: 10.1016/B978-0-444-64150-2.00020-4. — View 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. — View Citation

Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jääskeläinen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorová I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1. Review. Erratum in: Clin Neurophysiol. 2020 May;131(5):1168-1169. — View 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. Review. — View Citation

Ljubisavljevic M, Maxood K, Bjekic J, Oommen J, Nagelkerke N. Long-Term Effects of Repeated Prefrontal Cortex Transcranial Direct Current Stimulation (tDCS) on Food Craving in Normal and Overweight Young Adults. Brain Stimul. 2016 Nov - Dec;9(6):826-833. doi: 10.1016/j.brs.2016.07.002. Epub 2016 Jul 15. — View Citation

Martin AA, Davidson TL, McCrory MA. Deficits in episodic memory are related to uncontrolled eating in a sample of healthy adults. Appetite. 2018 May 1;124:33-42. doi: 10.1016/j.appet.2017.05.011. Epub 2017 May 4. — View Citation

Santos Ferreira I, Teixeira Costa B, Lima Ramos C, Lucena P, Thibaut A, Fregni F. Searching for the optimal tDCS target for motor rehabilitation. J Neuroeng Rehabil. 2019 Jul 17;16(1):90. doi: 10.1186/s12984-019-0561-5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pre-intervention.
Primary	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.	post-intervention (immediately after the end of study participation).
Primary	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.	pre-intervention.
Primary	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.	post-intervention (immediately after the end of study participation).
Secondary	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.	pre-intervention.
Secondary	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.	post-intervention (immediately after the end of study participation).
Secondary	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.	pre-intervention.
Secondary	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.	post-intervention (immediately after the end of study participation).
Secondary	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.	pre-intervention.
Secondary	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.	post-intervention (immediately after the end of study participation).

External Links

•   Ljubisavljevic M, Maxood K, Bjekic J, Oommen J, Nagelkerke N.
•   Martin AA, Davidson TL, McCrory MA