Effect of Nutritional Counseling Associated With Transcranial Direct-current Stimulation in Binge Eating Reduction
- Conditions
- Cognitive Behavioral TherapyTranscranial Direct Current StimulationBinge-Eating Disorder
- Interventions
- Combination Product: a-tDCS and nutritional counselingCombination Product: s-tDCS and nutritional counselingBehavioral: Nutritional CounselingDevice: a-tDCS
- Registration Number
- NCT04226794
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 40
- 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).
- Pregnancy
- shift workers
- treatment for weight loss in the last 30 days
- bariatric surgery
- formal contraindication for tDCS
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description a-tDCS and nutritional counseling a-tDCS and nutritional counseling a-tDCS and nutritional counseling s-tDCS and nutritional counseling s-tDCS and nutritional counseling s-tDCS and nutritional counseling Nutritional counseling Nutritional Counseling Nutritional counseling a-tDCS a-tDCS a-tDCS
- Primary Outcome Measures
Name Time Method Binge Eating Scale (BES) 20 minutes 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).
Short latency intracortical inhibition 40 minutes 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;
- Secondary Outcome Measures
Name Time Method % Weight loss change 5 minutes % Weight loss change over the treatment
% Reduction of waist circumference 5 minutes % Reduction of waist circumference over the treatment
State and Trait Food Craving Questionnaire (FCQ) 40 minutes The FCQ-T consists of 39 statements and was developed to access food cravings aspects over time and in various situations, considering them as a (usual) trait behavior of the respondent. Higher scores in this questionnaire are related to a more exaggerated eating. Higher scores in this questionnaire are related to a more exaggerated eating.
The FCQ-S is composed of 15 statements and is a tool sensitive to changes in contextual, psychological and physiological states in response to specific situations (such as stressful events or food deprivation), considering the food craving as a (sporadic) state behavior of the respondent. Higher scores in this questionnaire are associated with greater food deprivation, negative eating-related experiences and a greater susceptibility to triggers that lead to eating.
Totals of both tools for the full subscales and their dimensions are calculated by adding the corresponding scores of each statement.Intracortical Facilitation 40 minutes Transcranial magnetic stimulation (TMS) is a magnetic stimulation that can induces in the brain (or in spinal roots, or in nerves) electric currents that can depolarize neurons or their axons. The measures of this technic allow a comprehensive evaluation of the functional state of the corticospinal pathway useful for investigating both physiologic and pathologic conditions. TMS can be used to evaluate excitatory/inhibitory intracortical circuits and to provide information on brain physiology and pathophysiology of various neuropsychiatric diseases as well as on the mechanisms of brain plasticity Intracortical facilitation (ICF) is one of the facilitatory neurophysiological measures of the TMS and is thought to be mainly associated with glutamate receptor-mediated excitatory functions in the motor cortex. We don't have and data with Binge Eating Disorder and is extremely important as it is an indirect measure of Glutamate.
Leptin 5 minutes Leptin is a hormone predominantly made by adipose cells and the small intestine that helps to regulate energy balance by inhibiting hunger. It is an measure of homeostatic eating and considered an obesity biomarker.
Three Factor Eating-Questionnaire (TFEQ-R21) 15 minutes TFE-Q access three dimensions of human eating behavior:
Uncontrolled eating (UE) = Assesses the tendency to lose control over eating when feeling hungry or when exposed to external stimuli. Number of items (NI): 9. Lowest and highest possible raw scores(LH): 9-36.
Cognitive Restraint (CR) = Assesses the tendency to control food intake in order to influence body weight and body shape. NI: 6. LH: 6-24.
Emotional Eating (EE)= Measure the propensity to overeat in relation to negative mood states. NI: 6. LH: 6-24.
We will use the TFEQ-21. The average obtained from the sum of the questions for each domain was converted to a scale ranging from 0 to 100. Higher scores indicate more uncontrolled, restraint and emotional eating.Go/No-go 20 minutes measures impulse control by the ability to inhibit instigated, "prepotent" responses. The task manipulates response prepotency by presenting a preliminary go or no-go cue before the actual go or no-go target is displayed. The cues provide information concerning the probability that a go or no-go target will be presented. The cue-target relationship is manipulated so that the cues have a high probability of correctly signaling a go or no-go target (valid cues), and a low probability of incorrectly signaling a target (invalid cues). Valid cues tend to facilitate response inhibition and speed response execution, whereas invalid cue cues tend to impair response inhibition and slow response execution.
Silent period 40 minutes Intracortical inhibition can also be assessed by measurement of the cortical silent period (CSP), which is the interruption of electromyography (EMG) activity following a suprathreshold TMS pulse. The duration of the CSP is a measure of intracortical inhibition due to activation of GABAB interneurons that synapse on pyramidal neurons. We don't have and data with Binge Eating Disorder and is extremely important as it is an indirect measure of gamma-aminobutyrate (GABA).
Trial Locations
- Locations (1)
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil