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

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ClinicalTrials.gov Identifier: NCT03345368

Recruitment Status : Recruiting

First Posted : November 17, 2017

Last Update Posted : April 10, 2018

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Dra. Monica Ambriz Tututi, Hospital General Ajusco Medio

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity Anxiety	Device: rTMS Device: sham rTMS Other: Diet	Not Applicable

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 Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	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.
Masking:	Single (Participant)
Masking Description:	Sham rTMS will be administered with the coil held in contact with the head but at 180 degrees from scalp to avoid stimulation.
Primary Purpose:	Treatment
Official Title:	Effect of Repetitive Transcranial Magnetic Stimulation in Combination With a Low-carb Diet in Patients With Obesity: a Randomized Controlled Study
Actual Study Start Date :	September 26, 2017
Estimated Primary Completion Date :	May 29, 2018
Estimated Study Completion Date :	June 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: rTMS treated group 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 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. Other Name: repetitive transcranial magnetic stimulation Other: Diet 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. Other Name: conventional treatment
Sham Comparator: sham rTMS group 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 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. Other Name: placebo Other: Diet 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. Other Name: conventional treatment

Arm

Intervention/treatment

Experimental: rTMS treated group

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

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.

Other Name: repetitive transcranial magnetic stimulation

Other: Diet

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.

Other Name: conventional treatment

Sham Comparator: sham rTMS group

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

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.

Other Name: placebo

Other: Diet

Other Name: conventional treatment

Outcome Measures

Primary Outcome Measures :

Obesity, changes in the body mass index [ Time Frame: 7 days ]
Obesity is a body mass index greater than or equal to 30.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

BMI > 30

Exclusion Criteria:

Thyroid problems, anorexia, bulimia, epilepsy, schizophrenia

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345368

Contacts


Contact: Monica Ambriz-Tututi, Dr.	+525551321200 ext 7101	qfbmonica@hotmail.com
Contact: Beatriz Alvarado-Reynoso, MD	+525551321200 ext 7101	beatrizalvaradoreynoso@gmail.com

Locations


Mexico
Hospital General Ajusco Medio	Recruiting
Mexico, Tlalpan, Mexico, 14250
Contact: Beatriz Alvarado-Reynoso, MD +525551321200 ext 7101 beatrizalvaradoreynoso@gmail.com

Sponsors and Collaborators

Hospital General Ajusco Medio

Investigators


Study Director:	Monica Ambriz-Tututi, Dr.	HospitalGeneral Ajusco Medio

More Information

Publications of Results:

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.

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. Epub 2005 Aug 8.

Other Publications:

Alonso-Alonso M, Pascual-Leone A. The right brain hypothesis for obesity. JAMA. 2007 Apr 25;297(16):1819-22.

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.


Responsible Party:	Dra. Monica Ambriz Tututi, Especialista en área de Salud, Hospital General Ajusco Medio
ClinicalTrials.gov Identifier:	NCT03345368 History of Changes
Other Study ID Numbers:	211-010-01-17
First Posted:	November 17, 2017 Key Record Dates
Last Update Posted:	April 10, 2018
Last Verified:	April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
Time Frame:	Six months after study conclusion
URL:	http://


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No
Product Manufactured in and Exported from the U.S.:		No

Keywords provided by Dra. Monica Ambriz Tututi, Hospital General Ajusco Medio:


transcranial magnetic stimulation obesity diet

Additional relevant MeSH terms:


Obesity Overnutrition Nutrition Disorders	Overweight Body Weight Signs and Symptoms

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