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
Verified date | October 2022 |
Source | Universidade Federal do Piauí |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information.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.
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Universitário Do Piauí | Teresina | Piaui |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal do Piauí |
Brazil,
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
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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
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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). |
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