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

Obesity Clinical Trial

Official title:

Effect of Repetitive Transcranial Magnetic Stimulation in Combination With a Low-carbohydrate Diet in Patients With Obesity: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345368
• Other study ID #: 211-010-01-17
• Status: Completed
• Phase: N/A
• Start date: September 26, 2017
• Est. completion date: February 21, 2019

Study information

• Verified date: April 2019
• Source: Hospital General Ajusco Medio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 21, 2019
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• BMI > 30

Exclusion Criteria:

• Thyroid problems, anorexia, bulimia, epilepsy, schizophrenia

Related Conditions & MeSH terms

• Anxiety
• Obesity

Intervention

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.
• 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:
• 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.

Locations

Country	Name	City	State
Mexico	Hospital General Ajusco Medio	Mexico	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Ajusco Medio

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

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

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obesity, changes in the body mass index	Obesity is a body mass index greater than or equal to 30.	7 days