Clinical trial NCT04226794: Effect of Nutritional Counseling Associated With Transcranial Direct-current Stimulation in Binge Eating Reduction
Official title: Effect of Nutritional Counseling Associated With Transcranial Direct-current Stimulation in Binge Eating Reduction: A Single-blinded, Randomized Clinical Trial in Parallel With Simulated Use
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Transcranial Direct Current Stimulation
Binge-Eating Disorder
Cognitive Behavioral Therapy
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Binge eating disorder is the most prevalent eating disorder, with consequences not only economic but also social. It is related to a set of cognitive alterations related to impulsivity, cognitive function, attention, decision making, emotional control and physiological alterations in the Central nervous system (CNS) in the processing of rewards, mainly in the frontal cortical regions. Psychotherapies are the standard reference treatments, with Cognitive Behavioral Therapy (CBT) being the most indicated nonpharmacological intervention. However, the avoidance rates and the rates of non responders to treatment are significant. In view of this, it is believed that therapeutic approaches aimed at the modulation of the CNS, such as Transcranial direct-current stimulation (tDCS) may have a beneficial effect on the neurobiology of the processes that govern these disorders, thus adding to the effects of CBT and amplifying the therapeutic response.


Eligibility criteria: Inclusion Criteria:

* literate
* right - handed individuals
* body mass index ≥ 25 kg / m2
* meet the criteria of the Statistical Diagnostic Manual of Mental Disorders 5th edition (DSM - V) for Binge eating (4 to 7 episodes of binge eating per week).

Exclusion Criteria:

* Pregnancy
* shift workers
* treatment for weight loss in the last 30 days
* bariatric surgery
* formal contraindication for tDCS

Primary outcomes:
measure: Binge Eating Scale (BES)
timeFrame: 20 minutes
measure: Short latency intracortical inhibition
timeFrame: 40 minutes
Secondary outcomes:
measure: % Weight loss change
timeFrame: 5 minutes
measure: % Reduction of waist circumference
timeFrame: 5 minutes
measure: Three Factor Eating-Questionnaire (TFEQ-R21)
timeFrame: 15 minutes
measure: State and Trait Food Craving Questionnaire (FCQ)
timeFrame: 40 minutes
measure: Intracortical Facilitation
timeFrame: 40 minutes
measure: Go/No-go
timeFrame: 20 minutes
measure: Leptin
timeFrame: 5 minutes
measure: Silent period
timeFrame: 40 minutes
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: UFRGS and Hospital de Clínicas de Porto Alegre (HCPA)
name: Wolnei Caumo, PHD
role: STUDY_DIRECTOR
References:
citation: Kessler RM, Hutson PH, Herman BK, Potenza MN. The neurobiological basis of binge-eating disorder. Neurosci Biobehav Rev. 2016 Apr;63:223-38. doi: 10.1016/j.neubiorev.2016.01.013. Epub 2016 Feb 2.
citation: Imperatori C, Fabbricatore M, Farina B, Innamorati M, Quintiliani MI, Lamis DA, Contardi A, Della Marca G, Speranza AM. Alterations of EEG functional connectivity in resting state obese and overweight patients with binge eating disorder: A preliminary report. Neurosci Lett. 2015 Oct 21;607:120-124. doi: 10.1016/j.neulet.2015.09.026. Epub 2015 Sep 26.
citation: Peat CM, Berkman ND, Lohr KN, Brownley KA, Bann CM, Cullen K, Quattlebaum MJ, Bulik CM. Comparative Effectiveness of Treatments for Binge-Eating Disorder: Systematic Review and Network Meta-Analysis. Eur Eat Disord Rev. 2017 Sep;25(5):317-328. doi: 10.1002/erv.2517. Epub 2017 May 3.
citation: Fluckiger C, Meyer A, Wampold BE, Gassmann D, Messerli-Burgy N, Munsch S. Predicting premature termination within a randomized controlled trial for binge-eating patients. Behav Ther. 2011 Dec;42(4):716-25. doi: 10.1016/j.beth.2011.03.008. Epub 2011 May 27.
citation: Val-Laillet D, Aarts E, Weber B, Ferrari M, Quaresima V, Stoeckel LE, Alonso-Alonso M, Audette M, Malbert CH, Stice E. Neuroimaging and neuromodulation approaches to study eating behavior and prevent and treat eating disorders and obesity. Neuroimage Clin. 2015 Mar 24;8:1-31. doi: 10.1016/j.nicl.2015.03.016. eCollection 2015.