Effects of Non-invasive Neuromodulation on Food Desire, Chewing Pattern, Executive Functions and Oxidative Stress.
NCT ID: NCT05046145
Last Updated: 2022-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2021-07-13
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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tDCS + speech therapy+ sham
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
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.
sham + tDCS + speech therapy
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* both sexes;
* Age between 20 and 59 years old.
Exclusion Criteria
* 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.
18 Years
59 Years
ALL
Yes
Sponsors
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Universidade Federal do Piauí
OTHER
Responsible Party
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Marta Maria da Silva Lira Batista
Principal Investigator
Locations
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Hospital Universitário Do Piauí
Teresina, Piauí, Brazil
Countries
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References
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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.
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.
Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen 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, Rektorova 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.
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.
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.
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.
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.
Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
Diamond A. Executive functions. Handb Clin Neurol. 2020;173:225-240. doi: 10.1016/B978-0-444-64150-2.00020-4.
Related Links
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Ljubisavljevic M, Maxood K, Bjekic J, Oommen J, Nagelkerke N.
Martin AA, Davidson TL, McCrory MA
Other Identifiers
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tDCSONCRAVINGFOOD
Identifier Type: -
Identifier Source: org_study_id
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