Effect of rTMS in Combination With a Low-carbohydrate Diet in Patients With Obesity

Not Applicable

Completed

• Conditions: Obesity; Anxiety
• Interventions: Device: sham rTMS; Device: rTMS; Other: Diet

• Registration Number: NCT03345368
• Lead Sponsor: Hospital General Ajusco Medio

Brief Summary

In the present study the investigators want to evaluate if the application of rTMS can reduce the anxiety and craving in patients with obesity helping them to follow a low carb-diet, as well as, to assess the changes in weight, body mass index and quality of life before and after rTMS or sham rTMS.

Detailed Description

Participants completed a written, informed consent and rTMS adult safety questionnaire. The inclusion criteria are:

individuals between 25 and 60 years of age with obesity in stage 1, 2 or 3. The exclusion criteria were: subjects with metabolic disorders, neurological condition, epilepsy, or pregnancy. The study conformed to the Declaration of Helsinki and was approved by the Institutional Medical Research Ethics Committee (Hospital Ajusco Medio, Mexico DF). The protocol will be applied as follows: 10 rTMS or sham sessions during two weeks. Following these two week, patients will receive 8 more sessions on weeks 4, 6, 8, 10, 12, 16, 20 and 24. Diet will be indicated during all the protocol. The sham group will receive sham rTMS sessions for two weeks, the additional sessions will be performed in the same manner thar in rTMS group.

Study Timeline

• Study Start: 2017-09-26
• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-17
• Primary Completion: 2019-02-21
• Study Completion: 2019-02-21
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• BMI > 30

Exclusion Criteria

• Thyroid problems, anorexia, bulimia, epilepsy, schizophrenia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham rTMS group	sham rTMS	Sham rTMS will be administered with the coil held in contact with the head but a 180 degrees from scalp, and the power parameter will be reduced by half to avoid stimulation.b
rTMS treated group	Diet	A Magstim Rapid2 Stimulator equipped with a double 70mm alpha coil P/N 3191-00 (Magstim, Wales, UK) will be used to stimulate the motor cortex. Transcranial magnetic stimulation will be applied through a coil at 10 Hz, a field intensity of 90% of the motor threshold. Stimuli will be provided in 10 trains of 100 pulses, followed by a 28 s rest period.
sham rTMS group	Diet	Sham rTMS will be administered with the coil held in contact with the head but a 180 degrees from scalp, and the power parameter will be reduced by half to avoid stimulation.b
rTMS treated group	rTMS	A Magstim Rapid2 Stimulator equipped with a double 70mm alpha coil P/N 3191-00 (Magstim, Wales, UK) will be used to stimulate the motor cortex. Transcranial magnetic stimulation will be applied through a coil at 10 Hz, a field intensity of 90% of the motor threshold. Stimuli will be provided in 10 trains of 100 pulses, followed by a 28 s rest period.

Primary Outcome Measures

Name	Time	Method
Obesity, changes in the body mass index	7 days	Obesity is a body mass index greater than or equal to 30.

Trial Locations

Locations (1)

Hospital General Ajusco Medio; 🇲🇽 Mexico, Tlalpan, Mexico