Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649994
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Transcranial Magnetic Stimulation and Inhibitory Control Training to Reduce Binge Eating Brain and Behavioral Changes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transcranial Magnetic Stimulation and Inhibitory Control Training to Reduce Binge Eating Brain and Behavioral Changes BE-NEMOIC
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BE-NEMOIC
Brief Summary:
People with BE are characterized by high impulsivity high levels of craving for high-calorie foods deficits in inhibitory control and maladaptive decision making These characteristics are related at brain level to alterations in the activation of areas such as the dorsolateral prefrontal cortex DLPFC and ventromedial prefrontal cortex vmPFC among other brain areas and their connectivity The investigators propose an intervention that seeks to target these issues Thus the present study aims to characterize the effects of neuromodulation with intermittent theta burst stimulation iTBS of the DLPFC or the vmPFC in combination with inhibitory control training to produce brain cognitive and behavioral changes and modify altered biological parameters in people with BE Participants will be randomly allocated to one of three groups 1 a group that will receive active iTBS of the DLPFC together with inhibitory control training with a food GoNoGo paradigm and 2 a group that will receive active iTBS of the vmPFC together with inhibitory control training with a food GoNoGo paradigm and 3 an active control group that will receive sham iTBS together with inhibitory control training with a food GoNoGo paradigm The investigators hypothesized that neuromodulation with iTBS applied to DLPFC or vmPFC will modify the dynamics of different brain circuits associated with binge eating Neuromodulation of the DLPFC or vmPFC in combination with inhibitory control training will be associated with i decreased appraisal of unhealthy foods ii reduced food craving iii improved eating behavior iv modified brain connectivity and activation both at rest and linked to task performance with food stimuli v a decrease in the frequency and intensity of binge eating vi improved emotional symptoms and emotional eating depression anxiety emotional regulation emotional eating reward-related eating non-homeostatic eating vii improved cognitive abilities motor and cognitive inhibition delay of gratification impulsivity working memory cognitive flexibility and decision making viii changes in biological parameters associated to the interventions plasma and microbiota and ix advantages in cost-effectiveness and cost-utility based on economic evaluation analyses
Detailed Description:
1 STARTING HYPOTHESES AND GENERAL OBJECTIVE HYPOTHESIS Neuromodulation with intermittent theta burst stimulation iTBS applied to the left dorsolateral prefrontal cortex DLPFC or the ventromedial prefrontal cortex vmPFC in combination with inhibitory control training with a food GoNoGo paradigm will be associated with i decreased appraisal of unhealthy foods ii reduced food craving iii improved eating behavior iv modified brain connectivity and activation both at rest and linked to task performance with food stimuli v a decrease in the frequency and intensity of binge eating vi improved emotional symptoms and emotional eating depression anxiety emotional regulation emotional eating reward-related eating non-homeostatic eating vii improved cognitive abilities motor and cognitive inhibition delay of gratification impulsivity working memory cognitive flexibility and decision making viii changes in biological parameters associated to the interventions blood and microbiota and ix advantages in cost-effectiveness and cost-utility based on economic evaluation analyses
GENERAL OBJECTIVE To determine the effects of neuromodulation with iTBS in DLPFC or vmPFC in combination with inhibitory control training to generate brain behavioural emotional cognitive and biological changes in people with binge eating BE
11 Specific Aims Objective 1 To study the differential effect of iTBS applied to the left DLPFC compared to vmPFC and sham iTBS applied to vertex in combination with inhibitory control training for the treatment of people with binge eating improvements in frequency and intensity of binge eating craving eating behavior emotional symptoms and emotional eating cognitive measures and biological parameters
Objective 2 To characterize the effects of neuromodulation with iTBS of DLPFC or vmPFC in combination with inhibitory control training to modify brain connectivity and activation both at rest and linked to task performance with food stimuli with functional magnetic resonance imaging fMRI
Objective 3 To determine the relationship of biological parameters obtained in blood saliva urine and faeces as well as candidate genes with neuropsychological variables depression anxiety stress emotional regulation emotional eating craving motor and cognitive inhibition food valuation delay of gratification impulsivity working memory flexibility and decision making and brain neuroimaging activation grey and white matter volume connectivity
Objective 4 To analyze the economic evaluation of the cost-effectiveness and cost-utility of combined training neuromodulation with iTBS and inhibitory control training in people with BE and to analyze the budgetary impact of the program if it was implemented in the public health system
METHODOLOGY
21 Design Randomized controlled trial of parallel groups
22 Participants Participants N150 will be randomly allocated to three groups i group 1 active stimulation of the DLPFC with iTBS and inhibitory control training n50 ii group 2 active stimulation of the vmPFC with iTBS and inhibitory control training n50 group 3 active control group of sham iTBS and inhibitory control training n50
23 Interventions Pre-treatment interventions all groups First all participants will participate in a group briefing informational session about the study Also informative videos and brochures will be provided In this session no nutritional and exercise recommendations will be given
Intervention experimental and active control groups Duration 2 weeks of 5 daily sessions of about 10-20 minutes Sessions have two parts
Part 1 Neuromodulation with iTBS DLPFC or vmPFC or vertex 3 minutes net time Part 2 Inhibition training with the Food Trainer task 10 minutes net time
24 Outcome measures binge eating symptoms and food craving-stait will be the main outcome measures Secondary outcomes will measure changes in neuroimaging measures brain connectivity at rest food gono-go paradigm and food decision making tasks changes in eating behavior changes in emotional symptoms and emotional eating depression anxiety stress emotion regulation emotional eating reward-related eating non homeostatic eating biomarkers and cognitive measures Exploratory variables will include sociodemographic information previous treatments motivation for change and biological and clinical variables Further assessment will include screening and descriptive variables and measures to calculate cost-effectiveness cost-utility and budget impact of the intervention program
1 PROCEDURE Assessments will be delivered online through LimeSurvey and Milliseconds platforms Inclusion and exclusion criteria will be checked through the data collected in a questionnaire of sociodemographic and clinical variables Further psychopathology exclusion criteria will be tested with three questionnaires to measure depression anxiety and stress symptoms as well as severity of binge eating episodes BDI DASS-21 and QEWP-5 and a short clinical interview by phone andor information requested by email in those cases where there are doubts about any of the aspects collected through the online instruments
All candidates who meet the criteria will attend an information meeting about the project in which participants will receive written and oral information and will be asked for their informed consent Then participants will be randomly assigned to groups before the pre-treatment assessment sessions A simple randomization will be performed by generating five-letter codes with Calculadonet and randomizing the codes into three different groups using Rafflys The three groups of the study will complete all the three assessments pr post and 3-month follow-up What will differentiate the groups will be therefore the stimulation area active iTBS applied to the left DLPFC with inhibitory control training vs active iTBS applied to the vmPFC with inhibitory control training vs sham iTBS applied to the vertex with inhibitory control training At the end of the project if one treatment is more effective the other two groups will be offered the complete treatment sessions
Informative and assessment sessions will be developed in groups of 4-6 people through the platform GoogleMeet iTBS sessions will be administered individually If a participant misses a session it will be rescheduled for the beginning of the next week at a similar time There will be at least 10 experimental groups of DLPFC stimulation intervention combined with inhibitory control training 50 participants 10 experimental groups of vmPFC stimulation intervention combined with inhibitory control training 50 participants and 10 active control groups of sham stimulation 50 participants The program will comprise 5 weeks including two assessments pre- and post-treatment ten intervention sessions two weeks of 5 daily sessions and one information session Also a follow-up will be conducted 3 months after treatment see below Assessment sessions will last about 2 hours while intervention sessions will be approximately 10 to 20 minutes Sessions will consist of the following
1 Informative session session 1 week 1 For the participants to understand the foundation of the intervention participantes will be informed about the aims basis of the project and the procedure of the research Participants will be provided written informed consent as well At the end of this session participants will be asked for their informed written consent
2 Pre-treatment assessment session 2 and 3 week 2 All participants will complete in session 1 the following instruments to assess the main and secondary outcomes and the exploratory and economic measures WCST Food GoNoGo IGT Stroop Food DD N-Back CFA DASS-21 BDI-II PEMS RED DEBQ PSRSQ ERQ UPPS-P SF-36 SOCRATES 00 QEWP-5 sociodemographic questionnaire and questions about used health resources Also all participants will undergo the fMRI session session 2 and biological sample collection blood saliva feces and urine
3 Intervention sessions sessions 4 to 13 weeks 3 and 4 Intervention will consist of five weekly individual sessions for two weeks with a 10-20 minutes total duration each The stimulation parameters are based on the protocols for the application of iTBS in people with food intake problems and following international safety recommendations
The procedure in the three groups consists of
i Localization of the stimulation area by T1 sequence structural neuroimaging images using the Brainsight software for the correct placement of the stimulation coil in the active stimulation groups it will be the left DLPFC area x -37 y -34 z 78 corresponding to F3 position on the 10-20 EEG system or the vmPFC area x -24 y 66 z 12 corresponding to FP1 position on the 10-20 EEG system In the control group it will be the vertex x 0 y-34 z 78 an area without cognitive effects after stimulation but matching the sensory effects After that neuromodulation with iTBS for 3 minutes with parameters of frequency 50 Hz number of pulses 3 number of bursts 10 cycle duration 8 seconds number of cycles 20 burst frequency 5 Hz and total number of pulses 600 The stimulation intensity will be maintained at 30 of the stimulators maximum output
ii Cognitive inhibitory control training 10 minutes It will be performed with the Food T app for 10 minutes and will be applied immediately after the iTBS taking advantage of its time of maximum brain potentiation In this application the task consists of touching as quickly as possible the items that appear surrounded with a green circle and not responding to the items surrounded by a red circle Some images correspond to food and others are not related to food Participants can select the categories of the images participants want to train which should correspond to the foods used for binge eating candygummies cakes chocolate cookies alcohol chips bread cheese fast food - burgers take-out food - sweet sodas meat pizza Inhibitory control training consists of pairing high-calorie foods 100 of the time with the No-Go signal
4 Post-treatment assessment session 14 and 15 week 5 To evaluate the effectiveness of the interventions BMI and craving FCQ-TS-r will be registered main outcomes and the following instruments will be administered to obtain the secondary outcomes WCST Food GoNoGo IGT Stroop Food DD N-Back CFA DASS-21 BDI-II PEMS RED DEBQ PSRSQ ERQ UPPS-P SF-36 and questions about used health resources Also fMRI and biological samples of the pre-treatment assessment will be repeated
5 Follow-up sessions 16 week 15 Follow-up at 3 months after the intervention will include the following measures WCST Food GoNoGo IGT Stroop Food DD N-Back CFA DASS-21 BDI-II PEMS RED DEBQ PSRSQ ERQ UPPS-P SF-36 and interview about used health resources sociodemographic questionnaire and questions about used health resources and collection of biological samples and anthropometric measures to obtain the main and secondary outcome measures Every month after the end of the treatment participants will be contacted by email and mobile message to maintain adherence
Participants will be instructed to eat two hours before all evaluations pre- and post-treatment and the follow-up and iTBS sessions All the assessments will be carried out at the same hour
GENERAL OBJECTIVE To determine the effects of neuromodulation with iTBS in DLPFC or vmPFC in combination with inhibitory control training to generate brain behavioural emotional cognitive and biological changes in people with binge eating BE
11 Specific Aims Objective 1 To study the differential effect of iTBS applied to the left DLPFC compared to vmPFC and sham iTBS applied to vertex in combination with inhibitory control training for the treatment of people with binge eating improvements in frequency and intensity of binge eating craving eating behavior emotional symptoms and emotional eating cognitive measures and biological parameters
Objective 2 To characterize the effects of neuromodulation with iTBS of DLPFC or vmPFC in combination with inhibitory control training to modify brain connectivity and activation both at rest and linked to task performance with food stimuli with functional magnetic resonance imaging fMRI
Objective 3 To determine the relationship of biological parameters obtained in blood saliva urine and faeces as well as candidate genes with neuropsychological variables depression anxiety stress emotional regulation emotional eating craving motor and cognitive inhibition food valuation delay of gratification impulsivity working memory flexibility and decision making and brain neuroimaging activation grey and white matter volume connectivity
Objective 4 To analyze the economic evaluation of the cost-effectiveness and cost-utility of combined training neuromodulation with iTBS and inhibitory control training in people with BE and to analyze the budgetary impact of the program if it was implemented in the public health system
METHODOLOGY
21 Design Randomized controlled trial of parallel groups
22 Participants Participants N150 will be randomly allocated to three groups i group 1 active stimulation of the DLPFC with iTBS and inhibitory control training n50 ii group 2 active stimulation of the vmPFC with iTBS and inhibitory control training n50 group 3 active control group of sham iTBS and inhibitory control training n50
23 Interventions Pre-treatment interventions all groups First all participants will participate in a group briefing informational session about the study Also informative videos and brochures will be provided In this session no nutritional and exercise recommendations will be given
Intervention experimental and active control groups Duration 2 weeks of 5 daily sessions of about 10-20 minutes Sessions have two parts
Part 1 Neuromodulation with iTBS DLPFC or vmPFC or vertex 3 minutes net time Part 2 Inhibition training with the Food Trainer task 10 minutes net time
24 Outcome measures binge eating symptoms and food craving-stait will be the main outcome measures Secondary outcomes will measure changes in neuroimaging measures brain connectivity at rest food gono-go paradigm and food decision making tasks changes in eating behavior changes in emotional symptoms and emotional eating depression anxiety stress emotion regulation emotional eating reward-related eating non homeostatic eating biomarkers and cognitive measures Exploratory variables will include sociodemographic information previous treatments motivation for change and biological and clinical variables Further assessment will include screening and descriptive variables and measures to calculate cost-effectiveness cost-utility and budget impact of the intervention program
1 PROCEDURE Assessments will be delivered online through LimeSurvey and Milliseconds platforms Inclusion and exclusion criteria will be checked through the data collected in a questionnaire of sociodemographic and clinical variables Further psychopathology exclusion criteria will be tested with three questionnaires to measure depression anxiety and stress symptoms as well as severity of binge eating episodes BDI DASS-21 and QEWP-5 and a short clinical interview by phone andor information requested by email in those cases where there are doubts about any of the aspects collected through the online instruments
All candidates who meet the criteria will attend an information meeting about the project in which participants will receive written and oral information and will be asked for their informed consent Then participants will be randomly assigned to groups before the pre-treatment assessment sessions A simple randomization will be performed by generating five-letter codes with Calculadonet and randomizing the codes into three different groups using Rafflys The three groups of the study will complete all the three assessments pr post and 3-month follow-up What will differentiate the groups will be therefore the stimulation area active iTBS applied to the left DLPFC with inhibitory control training vs active iTBS applied to the vmPFC with inhibitory control training vs sham iTBS applied to the vertex with inhibitory control training At the end of the project if one treatment is more effective the other two groups will be offered the complete treatment sessions
Informative and assessment sessions will be developed in groups of 4-6 people through the platform GoogleMeet iTBS sessions will be administered individually If a participant misses a session it will be rescheduled for the beginning of the next week at a similar time There will be at least 10 experimental groups of DLPFC stimulation intervention combined with inhibitory control training 50 participants 10 experimental groups of vmPFC stimulation intervention combined with inhibitory control training 50 participants and 10 active control groups of sham stimulation 50 participants The program will comprise 5 weeks including two assessments pre- and post-treatment ten intervention sessions two weeks of 5 daily sessions and one information session Also a follow-up will be conducted 3 months after treatment see below Assessment sessions will last about 2 hours while intervention sessions will be approximately 10 to 20 minutes Sessions will consist of the following
1 Informative session session 1 week 1 For the participants to understand the foundation of the intervention participantes will be informed about the aims basis of the project and the procedure of the research Participants will be provided written informed consent as well At the end of this session participants will be asked for their informed written consent
2 Pre-treatment assessment session 2 and 3 week 2 All participants will complete in session 1 the following instruments to assess the main and secondary outcomes and the exploratory and economic measures WCST Food GoNoGo IGT Stroop Food DD N-Back CFA DASS-21 BDI-II PEMS RED DEBQ PSRSQ ERQ UPPS-P SF-36 SOCRATES 00 QEWP-5 sociodemographic questionnaire and questions about used health resources Also all participants will undergo the fMRI session session 2 and biological sample collection blood saliva feces and urine
3 Intervention sessions sessions 4 to 13 weeks 3 and 4 Intervention will consist of five weekly individual sessions for two weeks with a 10-20 minutes total duration each The stimulation parameters are based on the protocols for the application of iTBS in people with food intake problems and following international safety recommendations
The procedure in the three groups consists of
i Localization of the stimulation area by T1 sequence structural neuroimaging images using the Brainsight software for the correct placement of the stimulation coil in the active stimulation groups it will be the left DLPFC area x -37 y -34 z 78 corresponding to F3 position on the 10-20 EEG system or the vmPFC area x -24 y 66 z 12 corresponding to FP1 position on the 10-20 EEG system In the control group it will be the vertex x 0 y-34 z 78 an area without cognitive effects after stimulation but matching the sensory effects After that neuromodulation with iTBS for 3 minutes with parameters of frequency 50 Hz number of pulses 3 number of bursts 10 cycle duration 8 seconds number of cycles 20 burst frequency 5 Hz and total number of pulses 600 The stimulation intensity will be maintained at 30 of the stimulators maximum output
ii Cognitive inhibitory control training 10 minutes It will be performed with the Food T app for 10 minutes and will be applied immediately after the iTBS taking advantage of its time of maximum brain potentiation In this application the task consists of touching as quickly as possible the items that appear surrounded with a green circle and not responding to the items surrounded by a red circle Some images correspond to food and others are not related to food Participants can select the categories of the images participants want to train which should correspond to the foods used for binge eating candygummies cakes chocolate cookies alcohol chips bread cheese fast food - burgers take-out food - sweet sodas meat pizza Inhibitory control training consists of pairing high-calorie foods 100 of the time with the No-Go signal
4 Post-treatment assessment session 14 and 15 week 5 To evaluate the effectiveness of the interventions BMI and craving FCQ-TS-r will be registered main outcomes and the following instruments will be administered to obtain the secondary outcomes WCST Food GoNoGo IGT Stroop Food DD N-Back CFA DASS-21 BDI-II PEMS RED DEBQ PSRSQ ERQ UPPS-P SF-36 and questions about used health resources Also fMRI and biological samples of the pre-treatment assessment will be repeated
5 Follow-up sessions 16 week 15 Follow-up at 3 months after the intervention will include the following measures WCST Food GoNoGo IGT Stroop Food DD N-Back CFA DASS-21 BDI-II PEMS RED DEBQ PSRSQ ERQ UPPS-P SF-36 and interview about used health resources sociodemographic questionnaire and questions about used health resources and collection of biological samples and anthropometric measures to obtain the main and secondary outcome measures Every month after the end of the treatment participants will be contacted by email and mobile message to maintain adherence
Participants will be instructed to eat two hours before all evaluations pre- and post-treatment and the follow-up and iTBS sessions All the assessments will be carried out at the same hour
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None