Effect of Nutritional Counseling Associated With Transcranial Direct-current Stimulation in Binge Eating Reduction
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2019
CompletedFirst Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedDecember 28, 2022
December 1, 2022
2.5 years
July 2, 2019
December 27, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Binge Eating Scale (BES)
The Binge Eating Scale is a sixteen item questionnaire used to assess the presence of binge eating behavior indicative of an eating disorder. The questions are based upon both behavioral characteristics (e.g., amount of food consumed) and the emotional, cognitive response, guilt or shame. Each question has 3-4 separate responses assigned a numerical value. The score range is from 0-46= Non-binging (less than 17); Moderate binging (18-26); Severe binging (27 and greater).
20 minutes
Short latency intracortical inhibition
Cortical excitability reflects a balance between inhibitory and facilitatory neuronal circuits projected through pyramidal tract output tracts. Transcranial magnetic simulation (TMS) applied to the primary motor cortex (M1) has become widely utilized to assess cortical physiology using paired-pulse paradigms. Preceding subthreshold conditioning stimulus (CS) inhibits the excitability of the motor cortex, which is named short-interval intracortical inhibition (SICI). SICI is a standard method to estimate excitability in a GABAA-ergic circuit in the human cortex;
40 minutes
Secondary Outcomes (8)
% Weight loss change
5 minutes
% Reduction of waist circumference
5 minutes
Three Factor Eating-Questionnaire (TFEQ-R21)
15 minutes
State and Trait Food Craving Questionnaire (FCQ)
40 minutes
Intracortical Facilitation
40 minutes
- +3 more secondary outcomes
Study Arms (4)
a-tDCS and nutritional counseling
EXPERIMENTALa-tDCS and nutritional counseling
s-tDCS and nutritional counseling
ACTIVE COMPARATORs-tDCS and nutritional counseling
a-tDCS
ACTIVE COMPARATORa-tDCS
Nutritional counseling
ACTIVE COMPARATORNutritional counseling
Interventions
Anodal Transcranial direct current stimulation (tDCS) stimulation. Anode will be allocated at DLPFC right and cathode at DLPFC left. The stimulation will occur for 20 min in the intensity of 2 milliampere (mA).
Presentation delivered through video clip during 20 minutes based on Cognitive Behavioral Therapy interventions
a-tDCS + Nutritional Counseling
s-tDCS + Nutritional Counseling
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Pregnancy
- shift workers
- treatment for weight loss in the last 30 days
- bariatric surgery
- formal contraindication for tDCS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.450-120, Brazil
Related Publications (6)
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.
PMID: 26850211BACKGROUNDImperatori 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.
PMID: 26409786BACKGROUNDPeat 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.
PMID: 28467032BACKGROUNDFluckiger 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.
PMID: 22035999BACKGROUNDVal-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.
PMID: 26110109BACKGROUNDElkfury JL, Antunes LC, Weydmann G, Menegassi LN, Medeiros LF, Cardinal TM, Tocchetto BF, Torres ILS, Fregni F, Bizarro L, Caumo W. The effect of transcranial direct current stimulation and nutritional counseling therapy on attentional bias to food cues: A randomized clinical trial. Clin Nutr ESPEN. 2025 Dec 26;72:102886. doi: 10.1016/j.clnesp.2025.102886. Online ahead of print.
PMID: 41456817DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wolnei Caumo, PHD
UFRGS and Hospital de Clínicas de Porto Alegre (HCPA)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Only the tDCS intervention was masked
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, surgery departament
Study Record Dates
First Submitted
July 2, 2019
First Posted
January 13, 2020
Study Start
June 10, 2019
Primary Completion
December 21, 2021
Study Completion
December 31, 2023
Last Updated
December 28, 2022
Record last verified: 2022-12