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

NCT03345368 | Completed

• 1 other identifier: 211-010-01-17
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Anxiety

Keywords

transcranial magnetic stimulation; obesity; diet

Outcome Measures

Primary Outcomes (1)

• Obesity, changes in the body mass index

  Obesity is a body mass index greater than or equal to 30.

  7 days

Study Arms (2)

rTMS treated group

EXPERIMENTAL

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.

Device: rTMS; Other: Diet

sham rTMS group

SHAM COMPARATOR

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

Device: sham rTMS; Other: Diet

Interventions

rTMS DEVICE

Patients will be stimulated in the dorso lateral frontal cortex. First, the motor threshold will be determined for each patient. To induce currents to the left primary sensory-motor cortex hand area (M1/S1) the coil will be placed over the scalp oriented at 45 ° from the mid-sagittal plane while subjects will sit comfortably on a chair. The coil will be systematically moved in this area until a contraction of the abductor will be identified. Motor evoked potentials (MEPs). MEPs will be registered with surface electrodes on the left hand abductor pollicis muscle using the same Magstim equipment. Then the parameters will be adjusted for the stimulation as was described before.

Also known as: repetitive transcranial magnetic stimulation

rTMS treated group

sham rTMS DEVICE

As well as the rTMS group, the motor threshold of each patient will be determined. They will experience a similar rTMS session with the difference that they not will be stimulated.

Also known as: placebo

sham rTMS group

Diet OTHER

This intervention will be applied to both groups, rTMS and sham group, as a combined therapy. The diet is low in carbohydrates, like sugary foods, pasta and bread. Instead, patients eat food with protein, natural fats and vegetables.

Also known as: conventional treatment

rTMS treated group; sham rTMS group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI \> 30

You may not qualify if:

• Thyroid problems, anorexia, bulimia, epilepsy, schizophrenia

Sponsors & Collaborators

• Hospital General Ajusco Medio: lead

Study Sites (1)

Hospital General Ajusco Medio

México, Tlalpan, 14250, Mexico

Location

Related Publications (4)

• Alonso-Alonso M, Pascual-Leone A. The right brain hypothesis for obesity. JAMA. 2007 Apr 25;297(16):1819-22. doi: 10.1001/jama.297.16.1819. No abstract available.

  PMID: 17456824 BACKGROUND

• Kober H, Mende-Siedlecki P, Kross EF, Weber J, Mischel W, Hart CL, Ochsner KN. Prefrontal-striatal pathway underlies cognitive regulation of craving. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14811-6. doi: 10.1073/pnas.1007779107. Epub 2010 Aug 2.

  PMID: 20679212 BACKGROUND

• Barth KS, Rydin-Gray S, Kose S, Borckardt JJ, O'Neil PM, Shaw D, Madan A, Budak A, George MS. Food cravings and the effects of left prefrontal repetitive transcranial magnetic stimulation using an improved sham condition. Front Psychiatry. 2011 Mar 14;2:9. doi: 10.3389/fpsyt.2011.00009. eCollection 2011.

  PMID: 21556279 RESULT

• Uher R, Yoganathan D, Mogg A, Eranti SV, Treasure J, Campbell IC, McLoughlin DM, Schmidt U. Effect of left prefrontal repetitive transcranial magnetic stimulation on food craving. Biol Psychiatry. 2005 Nov 15;58(10):840-2. doi: 10.1016/j.biopsych.2005.05.043. Epub 2005 Aug 8.

  PMID: 16084855 RESULT

MeSH Terms

Conditions

Obesity; Anxiety Disorders

Interventions

Transcranial Magnetic Stimulation; Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Monica Ambriz-Tututi, Dr.

  HospitalGeneral Ajusco Medio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sham rTMS will be administered with the coil held in contact with the head but at 180 degrees from scalp to avoid stimulation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Especialista en área de Salud

Model Details: Study participants will be randomly assigned to one of two groups: the experimental group receiving rTMS and a placebo group receiving sham rTMS. Both groups will be on the low-carb diet.

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: September 26, 2017
• Primary Completion: February 21, 2019
• Study Completion: February 21, 2019
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Six months after study conclusion

Locations

ME (1)