Transcranial Magnetic Stimulation and Inhibitory Control Training to Reduce Binge Eating: Brain and Behavioral Changes
NCT06649994, Not applicable, Recruiting, Raquel Vilar López
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Transcranial Magnetic Stimulation and Inhibitory Control Training to Reduce Binge Eating: Brain and Behavioral Changes | ClinicalTrials.gov |
| NCT number | NCT06649994 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 150 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Raquel Vilar López | ClinicalTrials.gov |
| Conditions | Binge Eating, Inhibition, Psychological | ClinicalTrials.gov |
| Interventions | Active iTBS of the DLPFC, Active iTBS of the vmPFC, iTBS of the vertex (sham), Computerized inhibitory control training | ClinicalTrials.gov |
| First posted | 2024-10-21 | ClinicalTrials.gov |
| Last updated | 2025-03-25 | ClinicalTrials.gov |
Registered outcomes 45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Binge eating symptoms | Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17) | 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) | ClinicalTrials.gov |
| Primary | Food craving | This will be measured in Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17) | 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. | ClinicalTrials.gov |
| Secondary | Changes in Food decision making (neuroimaging measures) | From baseline (week 2) to the end of the treatment (week 5) | 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). | ClinicalTrials.gov |
| Secondary | Changes in Brain connectivity at rest (neuroimaging measures) | From baseline (week 2) to the end of the treatment (week 5) | 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. | ClinicalTrials.gov |
| Secondary | Changes in White matter integrity (neuroimaging measures) | From baseline (week 2) to the end of the treatment (week 5) | 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. | ClinicalTrials.gov |
| Secondary | Changes in Food Go/No-go Paradigm (neuroimaging measures) | From baseline (week 2) to the end of the treatment (week 5) | Activation during Go and No-go items will be calculated according to the type of images (high calorie and low-calorie foods). | ClinicalTrials.gov |
| Secondary | Changes in eating behavior | From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17) | 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. | ClinicalTrials.gov |
| Secondary | Anxiety and Stress. Mean change from baseline at post-intervention | From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17) | 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 | ClinicalTrials.gov |
| Secondary | Depression symptoms. Mean change from baseline at post-intervention | From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17) | 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 | ClinicalTrials.gov |
| Secondary | Non homeostatic eating. Mean change from baseline at post-intervention | From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17) | 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). | ClinicalTrials.gov |
| Secondary | Reward-related eating. Mean change from baseline at post-intervention | From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17) | 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. | ClinicalTrials.gov |
| Secondary | Emotional eating. Mean change from baseline at post-intervention | From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17) | 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. | ClinicalTrials.gov |
| Secondary | Emotion Regulation Strategies. Mean change from baseline at post-intervention | From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17) | 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). | ClinicalTrials.gov |
| Secondary | Motor inhibition. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17) | 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. | ClinicalTrials.gov |
| Secondary | Cognitive inhibition. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17) | 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. | ClinicalTrials.gov |
| Secondary | Delay of gratification. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17) | 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. | ClinicalTrials.gov |
| Secondary | Inhibition and activation systems. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17) | 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. | ClinicalTrials.gov |
| Secondary | Self-reported impulsivity. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17) | 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 | ClinicalTrials.gov |
| Secondary | Working Memory. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17) | 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. | ClinicalTrials.gov |
| Secondary | Cognitive flexibility. Mean change from baseline at post-intervention | Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17) | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 23
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 8039375 | BACKGROUND | PubMed |
| 13539317 | BACKGROUND | PubMed |
| 15001004 | BACKGROUND | PubMed |
| 15664172 | BACKGROUND | PubMed |
| 19269631 | BACKGROUND | PubMed |
| 19833552 | BACKGROUND | PubMed |
| 20435052 | BACKGROUND | PubMed |
| 20539835 | BACKGROUND | PubMed |
| 21976290 | BACKGROUND | PubMed |
| 23421854 | BACKGROUND | PubMed |
| 24076018 | BACKGROUND | PubMed |
| 24177441 | BACKGROUND | PubMed |
| 24624116 | BACKGROUND | PubMed |
| 25545458 | BACKGROUND | PubMed |
| 28611698 | BACKGROUND | PubMed |
| 30045816 | BACKGROUND | PubMed |
| 30967808 | BACKGROUND | PubMed |
| 31667648 | BACKGROUND | PubMed |
| 33243615 | BACKGROUND | PubMed |
| 34728250 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Delay Discounting | Secondary outcome | ConductCognition |
| Go/No-Go Task | Secondary outcome | ConductCognition |
| Iowa Gambling Lite | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)