Clinical trial NCT03009695: Transcranial Magnetic Stimulation (TMS) in Obesity
Official title: Impact of Deep Transcranial Magnetic Stimulation (dTMS) on Satiety and Weight Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Food Craving
Appetite and General Nutritional Disorders
Keywords: Transcranial Magnetic Stimulation
Obesity
Food Craving
Appetite/Satiety Hormones
fMRI
Intestinal microbiota
Physical activity
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age: 22-65 years
2. If the patient is taking medications, it must take on a stable dose for at least a month
3. Obesity: ≤ 30 BMI ≤ 45
4. Ability to follow verbal or written instructions.

Exclusion Criteria:

1. Axis-I and II psychiatric disorders according to DSM criteria 5 (such as Major Depression, Bipolar Disorder, or Attention Deficit Disorder)
2. IQ score \< 85
3. Organic brain disorders: history of stroke, brain major surgery or head trauma
4. Pregnancy or lactation, absence of medically approved contraceptive methods in females of childbearing potential
5. Serious or poorly controlled diseases (hepatic, renal or hearth failure, atrial fibrillation or other heart rhythm disorders)
6. H yperglycemia - Fasting glucose level \> 170 mg/dl
7. Urine drug screen positive for amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates and phencyclidine
8. Positivity to blood alcohol test
9. Metal in any part of the head, except for dental fillings
10. Implanted infusion pumps
11. Intracardiac devices (pacemakers, heart valves ...)
12. History of diseases whose exacerbation could be fatal (e.g. cardiovascular disease, increased intracranial pressure)
13. History of epilepsy or a family history of epilepsy among first-degree relatives
14. Medications associated with lowered seizure threshold (such as antidepressants, anxiolytics...)
15. Treatment with anti-obesity medications or other medications influencing body weight within 3 month prior to Screening Visit
16. Starting a weight loss plan at any time during data collection for the subject
17. Patients affected by galactosemia, priapism and terminal illness
18. Patients on fluid restriction for SIADH or other conditions
19. Contraindications to perform the Magnetic Resonance Imaging (MRI).

Primary outcomes:
measure: Changes in food craving levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
Secondary outcomes:
measure: Changes in body weight induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Changes in Fat Mass (FM) rate induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Acute and chronic changes in insulin levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Acute and chronic changes in glucagon levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Acute and chronic changes in ghrelin levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Acute and chronic changes in leptin levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Acute and chronic changes in Growth Hormone (GH) levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Acute and chronic changes in Adreno-Cortico-Tropic Hormone (ACTH) levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Acute and chronic changes in Thyroid-Stimulating Hormone (TSH) levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Acute and chronic changes in Prolactin levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Acute and chronic changes in Cortisol levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Acute and chronic changes in Neuropeptide Y levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Changes in Beta-endorphin levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Changes in Epinephrine levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Changes in Norepinephrine levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Changes in Glucose levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Changes in Glycated Hemoglobin levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Changes in Cholesterol levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Changes in Triglyceride levels induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
Other outcomes:
measure: Changes in Resting Energy Expenditure (REE) induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Changes in Activity Energy Expenditure (AEE) induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Changes in cutaneous temperature induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Changes in food cue-induced activation of specific brain areas induced by repetitive dTMS and detected by Magnetic Resonance Imaging (fMRI) from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
measure: Assessment of adverse events
timeFrame: Through study completion, an average of 1 year
measure: Changes in gut microbiota composition induced by repetitive dTMS from baseline at 5 weeks
timeFrame: Baseline and end of treatment (5 weeks)
Locations:
city: San Donato Milanese
country: Italy
facility: San Donato Hospital
state: MI
Study officials:
References:
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