Anxiety, Obesity
Conditions
Keywords
transcranial magnetic stimulation, obesity, diet
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.
Interventions
DEVICErTMS
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.
DEVICEsham 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.
OTHERDiet
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.
Sponsors
Hospital General Ajusco Medio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* BMI \> 30
Exclusion criteria
* Thyroid problems, anorexia, bulimia, epilepsy, schizophrenia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obesity, changes in the body mass index | 7 days | Obesity is a body mass index greater than or equal to 30. |
Countries
Mexico
Outcome results
None listed