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

Hospital de Clinicas de Porto Alegre

Status and phase: Active, not recruiting; Phase 2

Conditions: Binge-Eating Disorder; Transcranial Direct Current Stimulation; Cognitive Behavioral Therapy

Treatments: Behavioral: Nutritional Counseling; Device: a-tDCS; Combination Product: a-tDCS and nutritional counseling; Combination Product: s-tDCS and nutritional counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT04226794

2019-0206

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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40 participants in 4 patient groups

a-tDCS and nutritional counseling

Experimental group

Description:

a-tDCS and nutritional counseling

Treatment:

Combination Product: a-tDCS and nutritional counseling

s-tDCS and nutritional counseling

Active Comparator group

Description:

s-tDCS and nutritional counseling

Treatment:

Combination Product: s-tDCS and nutritional counseling

a-tDCS

Active Comparator group

Description:

a-tDCS

Treatment:

Device: a-tDCS

Nutritional counseling

Active Comparator group

Description:

Nutritional counseling

Treatment:

Behavioral: Nutritional Counseling