Transcranial Magnetic Stimulation (TMS) in Obesity (NCT03009695) | Clinical Trial Compass
UnknownNot Applicable
Transcranial Magnetic Stimulation (TMS) in Obesity
Italy50 participantsStarted 2015-02
Plain-language summary
Obesity is a metabolic disease that has reached epidemic proportions. Insofar no long-term effective drug treatment was developed for obesity. Lyfe style modulation and bariatric surgery are the only interventions with a limited rate of success. Obesity is due to several factors, mainly linked to a neurophysiological mechanism of "food addiction". The use of repetitive deep Transcranial Magnetic Stimulation (dTMS) was proposed to reduce appetite and food craving in obese subjects, leading eventually to a weight reduction. dTMS was already tested successfully in other forms of addiction (smoking, alcohol, cocaine) and the usefulness of dTMS in the treatment of food addiction, and therefore in obesity, was hypothesized. End-points of this research will be: 1) effect on food craving; 2) acute and chronic effects on blood level of hormones acting on the appetite regulation; 3) chronic effects on body weight. The demonstration that a safe, non-invasive and repeatable methodology can treat obesity reducing food craving and modulating appetite/satiety hormones secretion will constitute a cornerstone in translational medicine of metabolic diseases.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age: 22-65 years
✓. If the patient is taking medications, it must take on a stable dose for at least a month
✓. Obesity: ≤ 30 BMI ≤ 45
✓. Ability to follow verbal or written instructions.
Exclusion criteria
✕. Axis-I and II psychiatric disorders according to DSM criteria 5 (such as Major Depression, Bipolar Disorder, or Attention Deficit Disorder)
✕. IQ score \< 85
✕. Organic brain disorders: history of stroke, brain major surgery or head trauma
✕. Pregnancy or lactation, absence of medically approved contraceptive methods in females of childbearing potential
✕. Serious or poorly controlled diseases (hepatic, renal or hearth failure, atrial fibrillation or other heart rhythm disorders)
✕. H yperglycemia - Fasting glucose level \> 170 mg/dl
What they're measuring
1
Changes in food craving levels induced by repetitive dTMS from baseline at 5 weeks
Timeframe: Baseline and end of treatment (5 weeks)