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

NCT05046145 | Completed DMC

• 1 other identifier: tDCSONCRAVINGFOOD
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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From the change in self-regulation, memory is inhibited, allowing individuals to suppress or ignore unwanted or outdated associations and thus help to filter information relevant to dietary goals from irrelevant information.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

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

Outcome Measures

Primary Outcomes (4)

• 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.

• 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).

• 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.

• 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 Outcomes (6)

• change in the final value of inflammation scores

  pre-intervention.

• change in the final value of inflammation scores

  post-intervention (immediately after the end of study participation).

• change in the final value of antioxidant activity

  pre-intervention.

• change in the final value of antioxidant activity

  post-intervention (immediately after the end of study participation).

• change in desire to consume food.

  pre-intervention.

Study Arms (2)

tDCS + speech therapy+ sham

EXPERIMENTAL

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

Behavioral: speech therapy for chewing + real tDCS

sham + tDCS + speech therapy

EXPERIMENTAL

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

Behavioral: speech therapy for chewing + real tDCS

Interventions

speech therapy for chewing + real tDCS BEHAVIORAL

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.

Also known as: speech therapy for chewing + sham tDCS

sham + tDCS + speech therapy; tDCS + speech therapy+ sham

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• being a health professional at the HU-UFPI (higher and technical levels);
• both sexes;
• Age between 20 and 59 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Piauí: lead

Study Sites (1)

Hospital Universitário Do Piauí

Teresina, Piauí, 64056200, Brazil

Location

Related Publications (9)

• 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.

  PMID: 27498606 BACKGROUND

• 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.

  PMID: 28479407 BACKGROUND

• 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.

  PMID: 31901449 BACKGROUND

• 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.

  PMID: 27866120 BACKGROUND

• 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.

  PMID: 12656297 BACKGROUND

• 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.

  PMID: 27372845 BACKGROUND

• 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.

  PMID: 31315679 BACKGROUND

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

  PMID: 23020641 BACKGROUND

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

  PMID: 32958176 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Memory Disorders; Inflammation

Interventions

Speech Therapy; Mastication

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants do not know what treatment they will receive. The outcomes assessor does not know treatment aplicado in participants sham or real).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: September 16, 2021
• Study Start: July 13, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)