Transcranial Magnetic Stimulation and Inhibitory Control Training to Reduce Binge Eating: Brain and Behavioral Changes

Browse trials for

• Bulimia 173

Keywords

• binge eating
• rTMS
• inhibitory control
• training

Bulimia

173 studies on the registry are indexed under Bulimia; 33 are open to participants now.

This study's planned enrollment of 150 is above the median of 60 across 143 interventional studies indexed under Bulimia.

Lead sponsor

Raquel Vilar López is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Study arms

• Experimental
  Active iTBS of the DLPFC

  The experimental group will: i) receive an informative session; ii) 2 sessions of pre-treatment assessment (one with fMRI and one with questionnaires); iii) participate in 10 daily individual intervention sessions that consist of iTBS of the left dlPFC followed immediately inhibitory control training, that will last about 10-20 minutes each; iv) 2 sessions of post-treatment assessment (one with fMRI and one with questionnaires); v) one follow-up assessment session three months after completing the intervention

  Device: Active iTBS of the DLPFC · Behavioral: Computerized inhibitory control training

• Experimental
  Active iTBS of the vmPFC

  The experimental group will: i) receive an informative session; ii) 2 sessions of pre-treatment assessment (one with fMRI and one with questionnaires); iii) participate in 10 daily individual intervention sessions that consist of iTBS of the vmPFC followed immediately by inhibitory control training, that will last about 10-20 minutes each; iv) 2 sessions of post-treatment assessment (one with fMRI and one with questionnaires); v) one follow-up assessment session three months after completing the intervention

  Device: Active iTBS of the vmPFC · Behavioral: Computerized inhibitory control training

• Placebo comparator
  Active Control

  The active control group will: i) receive an informative session; ii) 2 sessions of pre-treatment assessment (one with fMRI and one with questionnaires); iii) participate in 10 daily individual intervention sessions that consist of iTBS of the vertex (sham) followed immediately by inhibitory control training, that will last about 10-20 minutes each; iv) 2 sessions of post-treatment assessment (one with fMRI and one with questionnaires); v) one follow-up assessment session three months after completing the intervention

  Device: iTBS of the vertex (sham) · Behavioral: Computerized inhibitory control training

Interventions

• DeviceActive iTBS of the DLPFC

  Participants will receive a 3 minutes intermittent Theta Burst Stimulation of the DLPCF of the left hemisphere while not performing any other task

• DeviceActive iTBS of the vmPFC

  Participants will receive a 3 minutes active intermittent Theta Burst Stimulation of the vmPFC while not performing any other task

• DeviceiTBS of the vertex (sham)

  Participants will receive a 3 minutes active intermittent Theta Burst Stimulation of the vertex while not performing any other task

• BehavioralComputerized inhibitory control training

  Participants will perform the task of the FoodT app for 10 minutes immediately after iTBS (taking advantage of time of maximum brain potentiation, Rossi et al., 2009). This task pairs high-calorie meals with the no-go cue. Images appear on the left, right or center of the smartphone screen and they must touch it or not (depending on the cue) with their index finger as quickly as possible. Participants earn points for correct tap responses and lose points for incorrect tap responses: If the image has a green border around it, you must tap the image and win 1 point. But if the image has a red border around it, you must inhibit the tapping response or you will lose 1 point. Participants must respond as quickly and accurately as possible and improve reaction time. Pictures of healthy and unhealthy foods are always paired with the Go and the No-Go signal, respectively. Non-food images are paired 50% of the time with the Go and the No-Go signal

  Also known as: FoodT

Primary outcomes

1. Binge eating symptoms

   The Binge Eating Scale (BES) is a self-administered questionnaire composed of 16 items: eight items that describe behavioral manifestations (for example, eating fast or consuming large amounts of food) and eight items on associated feelings and cognitions (for example, fear of not stopping eating). Each item has a response range from 0 to 3 points (0 = no severity of the symptom, 3 = serious problems on the symptom)

   Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

2. Food craving

   The Food Craving Questionnaire Stait-reduced (FCQ-S-r) will be administered to obtain the total score, indicative of the craving state at the time of the evaluation.

   Time frame: This will be measured in Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

Secondary outcomes

1. Changes in Food decision making (neuroimaging measures)

   The task that will be used, consists of three phases: two rating phases and one decision phase with 50 food images. Participants have to answer on a 5-point Likert scale how healthy they consider the food to be (block 1) and how much they like the taste of the food (block 2). In the third block, the participant decides whether they prefer to eat a neutral reference food (calculated from the previous two blocks) or an alternative food. These forced choices lead to cognitive conflict when the reference food is considered tastier and the alternative food healthier or vice versa. Among trials with cognitive conflict, the choice of the healthier food is defined as a controlled choice, and the choice of the tastier food as an uncontrolled choice. Activation will be compared between the controlled vs. uncontrolled choice conditions. The task will be analysed to assess the brain activity associated with the task, using a psychophysiological interaction analyses (PPI).

   Time frame: From baseline (week 2) to the end of the treatment (week 5)

2. Changes in Brain connectivity at rest (neuroimaging measures)

   Participants will be instructed to remain still, with their eyes closed, trying not to think about anything in particular for 9 minutes to obtain images to study the resting connectivity of different brain networks. On the one hand, an independent component analyses (ICA) will be performed, which will allow comparison of the different brain networks, as a whole, between the groups, with special interest in those that have been shown to be altered in the PD population. On the other hand, seed-based connectivity analyses will be performed, in which changes in functional connectivity between the CPFDL and the rest of the brain will be observed.

   Time frame: From baseline (week 2) to the end of the treatment (week 5)

3. Changes in White matter integrity (neuroimaging measures)

   Participants will be asked to remain still for 10 minutes to obtain diffusion tensor imaging (DTI) which provides indirect measurements of the architecture and connectivity of white matter fibres. The study of the DTI images will be carried out with the FSL programme, which allows the integrity of the white matter of the different groups to be measured by evaluating the fractional anisotropy (FA) and apparent diffusion coefficient (ADC) maps.

   Time frame: From baseline (week 2) to the end of the treatment (week 5)

4. Changes in Food Go/No-go Paradigm (neuroimaging measures)

   Activation during Go and No-go items will be calculated according to the type of images (high calorie and low-calorie foods).

   Time frame: From baseline (week 2) to the end of the treatment (week 5)

5. Changes in eating behavior

   Eating behavior: Diet information during the last year (pre-treatment), two last weeks (post-treatment) and tree last months (follow-up) will be collected through a validated food frequency questionnaire (CFA) with 52 items in which participants must record quantities of all the foods and drinks they had consumed during those periods. These data will be transformed into the number of total calories ingested, as well as the number of calories from fats, carbohydrates, and sugars.

   Time frame: From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17)

6. Anxiety and Stress. Mean change from baseline at post-intervention

   The Depression Anxiety Stress Scale-21 (DASS-21) will be used, taking into account scores on the stress and anxiety subscales. The scores for both subscales range from 0 to 21, a higher score indicating higher anxiety or stress

   Time frame: From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17)

7. Depression symptoms. Mean change from baseline at post-intervention

   Depression symptoms will be measured with the BDI-II.This scale is asses severity of depression. The scores range from 0 to 63 points. The higher the score, the greater the severity of depressive symptoms

   Time frame: From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17)

8. Non homeostatic eating. Mean change from baseline at post-intervention

   Dutch Eating Behaviour Questionnaire (DEBQ): it will be administered to assess restrictive eating behaviours related to external cues and emotional states. Higher scores in each subscale reflect higher level of restrained, emotional, and external eating, respectively.The DEBQ uses a 5-point Likert scale, ranging from never (1) to very often (5). The average score is calculated for each subscale by adding scores obtained from individual items and dividing them by the number of items included in a subscale (mean range: 1-5).

   Time frame: From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17)

9. Reward-related eating. Mean change from baseline at post-intervention

   Reward-related eating. Reward-Based Eating Scale (RED): it is a 13 items questionnaire that assess worries about foods, losing intake control and absence of satiety. Higher scores reflect higher reward-based eating drive.

   Time frame: From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17)

10. Emotional eating. Mean change from baseline at post-intervention

    Emotional eating. Coping subscale of the Palatable Eating Motives Scale (PEMS): it will be used to evaluate the intentionality for eating palatable foods to face negative emotions. The coping subscale includes items that are scored on a 5-point Likert-type scale, the total range being from 5 to 25 points. Low scores indicate that the person rarely resorts to the consumption of pleasant foods as a strategy to cope with negative emotions or stressful situations. High scores suggest that the person frequently uses palatable food as a strategy to cope with stress or negative emotions, which may be related to unhealthy eating habits or emotional eating patterns.

    Time frame: From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17)

11. Emotion Regulation Strategies. Mean change from baseline at post-intervention

    Emotion Questionnaire (ERQ): It examines emotional regulation strategies. It10 items to examine cognitive reappraisal and expressive suppression strategies. In cognitive reappraisal the highest score (42) is associated with better emotional outcomes while in expressive suppression the highest score (28) is linked to poorer well-being. Each item is rated on a Likert scale from strongly disagree (1) to strongly agree (7).

    Time frame: From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17)

12. Motor inhibition. Mean change from baseline at post-intervention

    Motor inhibition: FoodT app will register reaction time and commission errors. In the FoodT app reaction time for the high-calorie and low-calorie foods paired with the go and the no-go signal. The average response time for go and no-go items will be calculated according to the type of images (appetizing and healthy foods), and commission errors will be recorded.

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

13. Cognitive inhibition. Mean change from baseline at post-intervention

    Cognitive inhibition: Food Stroop Task. Using a Stroop task with food, the interference of food-related words on task performance can be measured as an assessment of cognitive inhibition.

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

14. Delay of gratification. Mean change from baseline at post-intervention

    Delay of gratification: Food Delay Discounting (Food DD). Score on the Food Delay Discounting will be used to measure the sensitivity to immediate rewards vs higher value rewards delayed. Participants' choices are recorded for each trial. Each trial varies in terms of the amount of reward and the amount of time to wait. To model the decisions, a hyperbolic discounting function is generally used.

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

15. Inhibition and activation systems. Mean change from baseline at post-intervention

    This will be assessed using the Punishment Sensitivity and Reward Sensitivity Questionnaire (PSRSQ) of 48 items. Responses in the scale are in a yes/no format. Higher punishment sensitivity scores are associated with lower number of punishable errors while higher reward sensitivity scores are linked to higher number of passive avoidance errors.

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

16. Self-reported impulsivity. Mean change from baseline at post-intervention

    Impulsive behaviour scale (UPPS-P). Self-reported impulsivity will be measured with Impulsive behaviour scale (UPPS-P). It consists of 20 items scored on a four point Likert scale, ranging from strongly agree (1) to strongly disagree (4). Higher scores mean worse outcome in impulsivity, while lower scores are related to better self-control and regulation

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

17. Working Memory. Mean change from baseline at post-intervention

    Working Memory: N-back Task will be assessed using N-back Task score based on accuracy and reaction times. Higher accuracy scores indicate stronger working memory and attention, while faster reaction times are linked to quicker processing speed and decision-making.

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

18. Cognitive flexibility. Mean change from baseline at post-intervention

    The Wisconsin Card Sorting Test (WCST) requires sorting response cards with one of four stimulus cards, using feedback based on a rule. Wisconsin Card Sorting Test will be administered to measure shift strategy in response to changing contingencies. There are128 trials where more correct responses, fewer perseverative and non perseverative errors, and more completed categories (max 6) are related to better performance

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

19. Decision making. Mean change from baseline at post-intervention

    Decision making: The Iowa Gambling Task (IGT) assess real-world decision-making in a lab settin using money rewards. Iowa Gambling Task will be used to assess decision-making using money rewards.

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

Other outcomes

1. Descriptive measures

   A socio-demographic questionnaire will be administered to examine age, education, gender, socio-economic variables and clinical variables to consider exclusion and inclusion criteria. All these variables are qualitative.

   Time frame: Pre-treatment assessment (week 2)

2. Depression Symptoms. Screening

   Beck Depression Inventory (BDI-II) The Beck Depression Inventory (BDI-II) will also be used to rule out major depressive symptoms as an exclusion criteria. The scores range from 0 to 63 points. Participants with a score higher than 29, indicative of severe symptoms, will be excluded.

   Time frame: Pre-treatment assessment (week 2)

3. Anxiety Symptoms. Screening

   Depression Anxiety and Stress Scale-21 (DASS-21) The anxiety subscale of the DASS-21 will also be used to rule out symptoms of major anxiety as an exclusion criterion. The scores for both subscales range from 0 to 21. Participants with a score higher than 8, indicative of severe symptoms, will be excluded from the study.

   Time frame: Pre-treatment assessment (week 2)

4. Eating and Weight Patterns. Screening

   Questionnaire on Eating and Weight Patterns-5 (QEWP-5): it is adapted to DSM-5 criteria and will be used to exclude people with binge eating problems and bulimia. The QEWP-5 is not scored on a traditional numerical scale like other psychological tests; instead, responses are used to identify the presence of eating disorder symptoms. Positive responses to key questions about the frequency of binge eating, compensatory behaviors, and emotional distress may indicate the presence of an eating disorder.

   Time frame: Pre-treatment assessment (week 2)

5. Using of Health Resources

   The Health Resources Questionnaire asks how often and why people have needed medical care and medicines in the last 3 month to measure the impact of the intervention in terms of health uses. Fewer visits to health professionals will be indicative of improvement.

   Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)

6. Motivation to change

   Motivation to change. The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 00) adapted to excess weight will be used to assess motivation to change habits. It has 18 items that score readiness to change in people with abusive food use with a five point Likert scale, ranging from strongly disagree (1) to strongly agree (5). Higher scores mean better outcome in relation to motivation to change, while higher scores on ambivalence suggest doubts about the motivation to change.

   Time frame: Pre-treatment assessment (week 2)

7. Previous treatment history

   History of previous treatment, from pharmacological or nutritional to psychological, should be recorded.

   Time frame: Pre-treatment assessment (week 2)

8. Quality of Life (Measures to calculate cost effectiveness, cost utility and budget impact analyses)

   SF-36 Quality of Life Questionnaire: Using the tariff validated for Spain. The SF-36 (Short Form 36 Health Survey) is one of the most widely used questionnaires to measure health-related quality of life. It consists of 36 questions assessing eight key dimensions: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health. Each dimension is scored on a scale of 0 to 100, where 0 represents the worst health status and 100 the best.

   Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

9. Years of Life Adjusted for Quality (Measures to calculate cost effectiveness, cost utility and budget impact analyses)

   Years of Life Adjusted for Quality (QALY) is a measure used in healthcare to assess the value of medical treatments or interventions, combining quantity and quality of life. One QALY is equivalent to one year of life in full health. If a person lives a year with a reduced quality of life (due to illness, for example), a value of less than 1 is assigned, depending on the degree of well-being. This metric allows the effectiveness of different interventions to be compared, helping in health decision-making and resource allocation. It combines life years and quality (from SF-36) used in economic evaluation and cost-utility analyses of the intervention.

   Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

10. Binge Eating (BE) (Measures to calculate cost effectiveness, cost utility and budget impact analyses)

    Changes in BE, assessed with BES for cost-effectiveness. The Binge Eating Scale (BES) (Escrivá-Martínez et al., 2019) is a self-administered questionnaire composed of 16 items: eight items that describe behavioral manifestations (for example, eating fast or consuming large amounts of food) and eight items on associated feelings and cognitions (for example, fear of not stopping eating). Each item has a response range from 0 to 3 points (0 = no severity of the symptom, 3 = serious problems on the symptom)

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

11. Intensity of Food Craving (Measures to calculate cost effectiveness, cost utility and budget impact analyses)

    The FCQ-S-r will be used to assess the success of the intervention in the cost-effectiveness calculations.

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

12. Health Resource Costs (Measures to calculate cost effectiveness, cost utility and budget impact analyses)

    Health Resource Costs: Includes visits to primary care, emergencies, hospital admissions, and medication costs. The Health Resource Questionnaire will be used to assess the success of the intervention in the cost-effectiveness calculations.

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

13. iTBS Session Staff Time (Measures to calculate cost effectiveness, cost utility and budget impact analyses)

    Cost of a Clinical Psychology Area Specialist (FEA) for 3 minutes per session over 10 days, based on Andalusian Health Service remuneration will be used to assess the success of the intervention in the cost-effectiveness calculations.

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

14. Inhibitory Control Training Session Staff Time (Measures to calculate cost effectiveness, cost utility and budget impact analyses)

    Training Session Staff Time: Cost of a Clinical Psychology Specialist (FEA) for 10 minutes per session over 10 days, based on Andalusian Health Service remuneration will be used to assess the success of the intervention in the cost-effectiveness calculations.

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

15. Equipment Costs (Measures to calculate cost effectiveness, cost utility and budget impact analyses)

    Cost of fMRI and iTBS equipment will be used to assess the success of the intervention in the cost-effectiveness calculations.

    Time frame: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

16. Hormone levels (Biological samples collection)

    Biological samples will be collected and deep-frozen in the CIMCYC until mass analyses are performed at the end of the project. Fasting blood tests will determine hormone levels (pg/ml) of estradiol, progesterone, cortisol, leptin, adiponectin, TSH, thyroxine, triiodothyronine, ghrelin, glucagon and GLP-1. A total of 10 ml of blood will be collected and centrifuged to separate the plasma from the rest and stored at -80ºC

    Time frame: Measured at Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17).

17. Glucose and triglycerides levels (Biological samples collection)

    Biological samples will be collected and deep-frozen in the CIMCYC until mass analyses are performed at the end of the project. Fasting blood tests will glucose and triglycerides levels (mg/dl). A total of 10 ml of blood will be collected and centrifuged to separate the plasma from the rest and stored at -80ºC

    Time frame: Measured at Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17).

18. Insulin levels (Biological samples collection)

    Biological samples will be collected and deep-frozen in the CIMCYC until mass analyses are performed at the end of the project. Fasting blood tests will determine insulin levels (U/ml). A total of 10 ml of blood will be collected and centrifuged to separate the plasma from the rest and stored at -80ºCa. Blood: Fasting blood tests will determine estradiol, progesterone, cortisol, leptin, adiponectin, TSH, thyroxine, triiodothyronine, ghrelin, glucagon, GLP-1, PYY (3-36), glucose, triglycerides, insulin, TNF-alpha, CRP, and IL-6. In addition, genetic analysis will be performed by sequencing candidate genes. A total of 10 ml of blood will be collected and centrifuged to separate the plasma from the rest and stored at -80ºC

    Time frame: Measured at Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17).

19. Inflammatory parameters (Biological samples collection)

    Biological samples will be collected and deep-frozen in the CIMCYC until mass analyses are performed at the end of the project. Fasting blood tests will determine IL-6, CRP, TNF-alpha levels (pg/ml). In addition, genetic analyseswill be performed by sequencing candidate genes. A total of 10 ml of blood will be collected and centrifuged to separate the plasma from the rest and stored at -80ºC

    Time frame: Measured at Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17).

20. Satiety markers (Biological samples collection)

    Biological samples will be collected and deep-frozen in the CIMCYC until mass analyses are performed at the end of the project. Fasting blood tests will determine PYY (3-36) levels (pg/ml). A total of 10 ml of blood will be collected and centrifuged to separate the plasma from the rest and stored at -80ºC

    Time frame: Measured at Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17).

21. Genetic analyses (Biological samples collection)

    Biological samples will be collected and deep-frozen in the CIMCYC until mass analyses are performed at the end of the project. Fasting blood tests will determine genetic analyses will be performed by sequencing candidate genes. Genome-wide association analysis is proposed to identify new genes and variants associated with PD such as ZFP36, GAD2 on chromosome 10p12, Neuromedin β with whole exome sequencing and methylation analysis.A total of 10 ml of blood will be collected and centrifuged to separate the plasma from the rest and stored at -80ºC

    Time frame: Measured at Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17).

22. Oral microbiota (Biological samples collection)

    Biological samples will be collected and deep-frozen in the CIMCYC until mass analyses are performed at the end of the project. Saliva samples for oral microbiota analyses will be collected using three swabs (right cheek, left cheek, tongue) that will be stored at -80ºC

    Time frame: Measured at Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17).

23. Gut microbiota (Biological samples collection)

    Biological samples will be collected and deep-frozen in the CIMCYC until mass analyses are performed at the end of the project. Participants will collect fecal samples and 1.5 g of the top layer will be stored in tubes at -80ºC for gut microbiota analyses.

    Time frame: Measured at Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17).

24. Proteomics analysis. (Biological samples collection)

    Biological samples will be collected and deep-frozen in the CIMCYC until mass analyses are performed at the end of the project. Samples for proteomics analyses will be collected in plastic bottles, centrifuged and stored at -80ºC

    Time frame: Measured at Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17).

Publications

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• Chen T, Su H, Li R, Jiang H, Li X, Wu Q, Tan H, Zhang J, Zhong N, Du J, Gu H, Zhao M. A transcranial magnetic stimulation protocol for decreasing the craving of methamphetamine-dependent patients. STAR Protoc. 2021 Nov 10;2(4):100944. doi: 10.1016/j.xpro.2021.100944. eCollection 2021 Dec 17. PubMed 34825214 ↗
• Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033. PubMed 15664172 ↗
• Kalla R, Muggleton NG, Cowey A, Walsh V. Human dorsolateral prefrontal cortex is involved in visual search for conjunctions but not features: a theta TMS study. Cortex. 2009 Oct;45(9):1085-90. doi: 10.1016/j.cortex.2009.01.005. Epub 2009 Feb 11. PubMed 19269631 ↗
• Keeler JL, Chami R, Cardi V, Hodsoll J, Bonin E, MacDonald P, Treasure J, Lawrence N. App-based food-specific inhibitory control training as an adjunct to treatment as usual in binge-type eating disorders: A feasibility trial. Appetite. 2022 Jan 1;168:105788. doi: 10.1016/j.appet.2021.105788. Epub 2021 Oct 30. PubMed 34728250 ↗
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• Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. PubMed 19833552 ↗
• Escriva-Martinez T, Galiana L, Rodriguez-Arias M, Banos RM. The Binge Eating Scale: Structural Equation Competitive Models, Invariance Measurement Between Sexes, and Relationships With Food Addiction, Impulsivity, Binge Drinking, and Body Mass Index. Front Psychol. 2019 Mar 22;10:530. doi: 10.3389/fpsyg.2019.00530. eCollection 2019. PubMed 30967808 ↗
• Meule A, Hermann T, Kubler A. A short version of the Food Cravings Questionnaire-Trait: the FCQ-T-reduced. Front Psychol. 2014 Mar 4;5:190. doi: 10.3389/fpsyg.2014.00190. eCollection 2014. PubMed 24624116 ↗
• Neveu R, Neveu D, Carrier E, Gay A, Nicolas A, Coricelli G. Goal Directed and Self-Control Systems in Bulimia Nervosa: An fMRI Study. EBioMedicine. 2018 Aug;34:214-222. doi: 10.1016/j.ebiom.2018.07.012. Epub 2018 Jul 22. PubMed 30045816 ↗
• Vioque J, Navarrete-Munoz EM, Gimenez-Monzo D, Garcia-de-la-Hera M, Granado F, Young IS, Ramon R, Ballester F, Murcia M, Rebagliato M, Iniguez C; INMA-Valencia Cohort Study. Reproducibility and validity of a food frequency questionnaire among pregnant women in a Mediterranean area. Nutr J. 2013 Feb 19;12:26. doi: 10.1186/1475-2891-12-26. PubMed 23421854 ↗
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Related links

• Web of the project ↗

Study documents

• Protocol and statistical analysis plan ↗ · Apr 16, 2024
• Informed consent form ↗ · Apr 16, 2024

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification, will be shared.

Time frame: Data will be available beginning 3 months and ending 5 years following article publication.

Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee and who provide a methodologically sound proposal. Proposals should be directed to rvilar@ugr.es