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Effect of Repetitive Transcranial Magnetic Stimulation in Combination With a Low-carbohydrate Diet in Patients With Obesity: a Randomized Controlled Study
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.
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.
Age
18 - 40 years
Sex
ALL
Healthy Volunteers
No
Hospital General Ajusco Medio
México, Tlalpan, Mexico
Start Date
September 26, 2017
Primary Completion Date
February 21, 2019
Completion Date
February 21, 2019
Last Updated
April 30, 2019
49
ACTUAL participants
rTMS
DEVICE
sham rTMS
DEVICE
Diet
OTHER
Lead Sponsor
Hospital General Ajusco Medio
NCT07472881
NCT01143454
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