Transcranial Magnetic Stimulation (TMS) in Binge Eating Disorder (BED)

Study Overview
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Brief Summary
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This study evaluates de efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) applied on the left dorsolateral prefrontal cortex in patients with binge eating disorder.

Detailed Description
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Binge Eating Disorder (BED) affects a significant percentage of de national population (1.4%) in a portio 2-1 in woman compared with men, the repetitive Transcranial Magnetic Stimulation (rTMS) is a neuromodulation technique, which allows us to induce brain electrical activity by plating magnetic fields and it has been proven that at 10Hz it has an effect of improvement in the craving of food.

Official Title
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Effect of the Transcranial Magnetic Stimulation Applied on the Left Dorsolateral Prefrontal Cortex on the Clinical and Neuropsychological Variables in Subjects With Binge Eating Disorder

Conditions
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Binge-Eating Disorder

Intervention / Treatment
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* Device: MagVenture MagPro R30


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of both sexes. Subjects from 18 to 45 years of age. Subjects with diagnosis of binge eating disorder. Subjects without changes in pharmacological treatment in the last 30 days. Subjects who agree to sign the informed consent letter. Exclusion Criteria: 1.Subjects with a history of traumatic brain injury with loss of consciousness. 2.Subjects with intracranial metallic objects or metal plates in the skull. 3.Subjects who suffer chronic diseases not controlled at the time of entering the study (for example: hypertension, diabetes, rheumatic diseases). 4.Patients with psychotic symptoms, bipolar affective disorders and substance dependence. 5.Subjects with alterations in electroencephalogram (epileptiform activity). 6.Patients with any type of chronic or neurological medical disease not controlled.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1500 pulses<br>This group will receive 1500 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions | Device: MagVenture MagPro R30<br>* the subjects will receive 1500 or 5000 pulses at 5Hz<br>* Other names: repetitive Transcranial Magnetic Stimulation;|
| Sham Comparator: 1500 pulses sham<br>this group will receive the sham modality of the protocol of 1500 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions. | Device: MagVenture MagPro R30<br>* the subjects will receive 1500 or 5000 pulses at 5Hz<br>* Other names: repetitive Transcranial Magnetic Stimulation;|
| Active Comparator: 5000 pulses<br>This group will receive 5000 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions. | Device: MagVenture MagPro R30<br>* the subjects will receive 1500 or 5000 pulses at 5Hz<br>* Other names: repetitive Transcranial Magnetic Stimulation;|
| Sham Comparator: 5000 pulses sham<br>this group will receive the sham modality of the protocol of 5000 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions. | Device: MagVenture MagPro R30<br>* the subjects will receive 1500 or 5000 pulses at 5Hz<br>* Other names: repetitive Transcranial Magnetic Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Craving Inventory (FCI) | The FCI is a self-report inventory designed to measure the food craving, is made up of 37 elements and is a scale-likert instrument. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barratt Impulsivity Scale (BIS-11) | The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality / behavioral construct of impulsiveness is composed of 30 items describing common impulsive or non-impulsive (for reversed scored items) behaviors and preferences . | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Binge Eating Disorder, Transcranial Magnetic Stimulation, Food Craving