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

Primary Purpose

Transcranial Direct Current Stimulation, Binge-Eating Disorder, Cognitive Behavioral Therapy

Status
Active
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
a-tDCS
Nutritional Counseling
a-tDCS and nutritional counseling
s-tDCS and nutritional counseling
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Hospital de Clinicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

a-tDCS and nutritional counseling

s-tDCS and nutritional counseling

a-tDCS

Nutritional counseling

Arm Description

a-tDCS and nutritional counseling

s-tDCS and nutritional counseling

a-tDCS

Nutritional counseling

Outcomes

Primary Outcome Measures

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).
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;

Secondary Outcome Measures

% Weight loss change
% Weight loss change over the treatment
% Reduction of waist circumference
% Reduction of waist circumference over the treatment
Three Factor Eating-Questionnaire (TFEQ-R21)
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.
State and Trait Food Craving Questionnaire (FCQ)
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
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.
Go/No-go
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.
Leptin
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.
Silent period
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).

Full Information

First Posted
July 2, 2019
Last Updated
December 27, 2022
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT04226794
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
December 21, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Direct Current Stimulation, Binge-Eating Disorder, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Only the tDCS intervention was masked
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
a-tDCS and nutritional counseling
Arm Type
Experimental
Arm Description
a-tDCS and nutritional counseling
Arm Title
s-tDCS and nutritional counseling
Arm Type
Active Comparator
Arm Description
s-tDCS and nutritional counseling
Arm Title
a-tDCS
Arm Type
Active Comparator
Arm Description
a-tDCS
Arm Title
Nutritional counseling
Arm Type
Active Comparator
Arm Description
Nutritional counseling
Intervention Type
Device
Intervention Name(s)
a-tDCS
Intervention Description
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
Behavioral
Intervention Name(s)
Nutritional Counseling
Intervention Description
Presentation delivered through video clip during 20 minutes based on Cognitive Behavioral Therapy interventions
Intervention Type
Combination Product
Intervention Name(s)
a-tDCS and nutritional counseling
Intervention Description
a-tDCS + Nutritional Counseling
Intervention Type
Combination Product
Intervention Name(s)
s-tDCS and nutritional counseling
Intervention Description
s-tDCS + Nutritional Counseling
Primary Outcome Measure Information:
Title
Binge Eating Scale (BES)
Description
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).
Time Frame
20 minutes
Title
Short latency intracortical inhibition
Description
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;
Time Frame
40 minutes
Secondary Outcome Measure Information:
Title
% Weight loss change
Description
% Weight loss change over the treatment
Time Frame
5 minutes
Title
% Reduction of waist circumference
Description
% Reduction of waist circumference over the treatment
Time Frame
5 minutes
Title
Three Factor Eating-Questionnaire (TFEQ-R21)
Description
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.
Time Frame
15 minutes
Title
State and Trait Food Craving Questionnaire (FCQ)
Description
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.
Time Frame
40 minutes
Title
Intracortical Facilitation
Description
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.
Time Frame
40 minutes
Title
Go/No-go
Description
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.
Time Frame
20 minutes
Title
Leptin
Description
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.
Time Frame
5 minutes
Title
Silent period
Description
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).
Time Frame
40 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo, PHD
Organizational Affiliation
UFRGS and Hospital de Clínicas de Porto Alegre (HCPA)
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90.450-120
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
26850211
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.
Results Reference
background
PubMed Identifier
26409786
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.
Results Reference
background
PubMed Identifier
28467032
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.
Results Reference
background
PubMed Identifier
22035999
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.
Results Reference
background
PubMed Identifier
26110109
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.
Results Reference
background

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

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