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

Not Applicable

Completed

• Conditions: Binge-Eating Disorder
• Interventions: Device: MagVenture MagPro R30

• Registration Number: NCT03540641
• Lead Sponsor: Universidad Autonoma de Queretaro

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-04-06
• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-30
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Subjects of both sexes.
2. Subjects from 18 to 45 years of age.
3. Subjects with diagnosis of binge eating disorder.
4. Subjects without changes in pharmacological treatment in the last 30 days.
5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1500 pulses	MagVenture MagPro R30	This group will receive 1500 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions
5000 pulses sham	MagVenture MagPro R30	this group will receive the sham modality of the protocol of 5000 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions.
1500 pulses sham	MagVenture MagPro R30	this group will receive the sham modality of the protocol of 1500 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions.
5000 pulses	MagVenture MagPro R30	This group will receive 5000 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions.

Primary Outcome Measures

Name	Time	Method
Food Craving Inventory (FCI)	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Barratt Impulsivity Scale (BIS-11)	6 weeks	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 .

Trial Locations

Locations (1)

Sofía Cañizares Gómez.; 🇲🇽 Querétaro City, Querétaro, Mexico