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Effect of Nutritional Counseling Associated With Transcranial Direct-current Stimulation in Binge Eating Reduction

NCT ID: NCT04226794

Last Updated: 2022-12-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-10

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Transcranial Direct Current Stimulation Binge-Eating Disorder Cognitive Behavioral Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Only the tDCS intervention was masked

Study Groups

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a-tDCS and nutritional counseling

a-tDCS and nutritional counseling

Group Type EXPERIMENTAL

a-tDCS and nutritional counseling

Intervention Type COMBINATION_PRODUCT

a-tDCS + Nutritional Counseling

s-tDCS and nutritional counseling

s-tDCS and nutritional counseling

Group Type ACTIVE_COMPARATOR

s-tDCS and nutritional counseling

Intervention Type COMBINATION_PRODUCT

s-tDCS + Nutritional Counseling

a-tDCS

a-tDCS

Group Type ACTIVE_COMPARATOR

a-tDCS

Intervention Type DEVICE

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).

Nutritional counseling

Nutritional counseling

Group Type ACTIVE_COMPARATOR

Nutritional Counseling

Intervention Type BEHAVIORAL

Presentation delivered through video clip during 20 minutes based on Cognitive Behavioral Therapy interventions

Interventions

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a-tDCS

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).

Intervention Type DEVICE

Nutritional Counseling

Presentation delivered through video clip during 20 minutes based on Cognitive Behavioral Therapy interventions

Intervention Type BEHAVIORAL

a-tDCS and nutritional counseling

a-tDCS + Nutritional Counseling

Intervention Type COMBINATION_PRODUCT

s-tDCS and nutritional counseling

s-tDCS + Nutritional Counseling

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Wolnei Caumo

Professor, surgery departament

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wolnei Caumo, PHD

Role: STUDY_DIRECTOR

UFRGS and Hospital de Clínicas de Porto Alegre (HCPA)

Locations

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Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 26850211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26409786 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28467032 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22035999 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26110109 (View on PubMed)

Other Identifiers

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2019-0206

Identifier Type: -

Identifier Source: org_study_id