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Transcranial Direct Current StimulationPhase 2NCT04226794

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

A Phase 2 study testing a-tDCS, Nutritional Counseling and a-tDCS and nutritional counseling in people with Transcranial Direct Current Stimulation and Binge-Eating Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
a-tDCS, Nutritional Counseling and a-tDCS and nutritional counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
10 Jun 2019to 31 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Pregnancy
  • shift workers
  • treatment for weight loss in the last 30 days
  • bariatric surgery
  • formal contraindication for tDCS

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90.450-120

Other trials in Brazil

About this study

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

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.

Being tested
a-tDCS, Nutritional Counseling, a-tDCS and nutritional counseling, s-tDCS and nutritional counseling
Medical subject headings
Binge-Eating Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • a-tDCSDevice

    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 CounselingBehavioural

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

  • a-tDCS and nutritional counselingCombination product

    a-tDCS + Nutritional Counseling

  • s-tDCS and nutritional counselingCombination product

    s-tDCS + Nutritional Counseling

Study groups in NCT04226794
Study groupRoleWhat they receive
a-tDCS and nutritional counselingExperimentala-tDCS and nutritional counseling
Receives: Combination Product: a-tDCS and nutritional counseling
s-tDCS and nutritional counselingActive comparators-tDCS and nutritional counseling
Receives: Combination Product: s-tDCS and nutritional counseling
a-tDCSActive comparatora-tDCS
Receives: Device: a-tDCS
Nutritional counselingActive comparatorNutritional counseling
Receives: Behavioral: Nutritional Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 20 minutes

  2. 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;

    Measured: 40 minutes

Secondary outcomes (8)

  1. % Weight loss change

    % Weight loss change over the treatment

    Measured: 5 minutes

  2. % Reduction of waist circumference

    % Reduction of waist circumference over the treatment

    Measured: 5 minutes

  3. 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.

    Measured: 15 minutes

  4. 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.

    Measured: 40 minutes

  5. 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.

    Measured: 40 minutes

  6. 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.

    Measured: 20 minutes

  7. 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.

    Measured: 5 minutes

  8. 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).

    Measured: 40 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start10 Jun 2019
  3. Primary completion21 Dec 2021
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04226794
Sponsor's protocol ID
2019-0206
Status last verified
Dec 2022
First submitted
2 Jul 2019
Last updated
28 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26850211

  • 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.

    PubMed 26409786

  • 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.

    PubMed 28467032

  • 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.

    PubMed 22035999

  • 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.

    PubMed 26110109

  • Elkfury 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. 2026 Apr;72:102886. doi: 10.1016/j.clnesp.2025.102886. Epub 2025 Dec 26.

    PubMed 41456817

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing a-tDCS, Nutritional Counseling and a-tDCS and nutritional counseling in people with Transcranial Direct Current Stimulation and Binge-Eating Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Binge Eating Scale (BES) (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04226794, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.

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