Clinical trial NCT03345368: Effect of rTMS in Combination With a Low-carbohydrate Diet in Patients With Obesity
Official title: Effect of Repetitive Transcranial Magnetic Stimulation in Combination With a Low-carbohydrate Diet in Patients With Obesity: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Anxiety
Keywords: transcranial magnetic stimulation
obesity
diet
Lead sponsor: Hospital General Ajusco Medio
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* BMI \> 30

Exclusion Criteria:

* Thyroid problems, anorexia, bulimia, epilepsy, schizophrenia

Primary outcomes:
measure: Obesity, changes in the body mass index
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Hospital General Ajusco Medio
state: Tlalpan
Study officials:
affiliation: HospitalGeneral Ajusco Medio
name: Monica Ambriz-Tututi, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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. doi: 10.3389/fpsyt.2011.00009. eCollection 2011.
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. doi: 10.1016/j.biopsych.2005.05.043. Epub 2005 Aug 8.