Transcranial Magnetic Stimulation (TMS) in Obesity

San Donato Group (GSD)

Status: Unknown

Conditions: Appetite and General Nutritional Disorders; Food Craving; Obesity

Treatments: Device: High frequency repetitive dTMS; Device: Sham; Device: Low frequency repetitive dTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03009695

SMT/obesi

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 5 patient groups

High frequency repetitive dTMS + Cue

Experimental group

Description:

10 obese individuals fulfilling all inclusion/exclusion criteria for the study will be randomized to active high frequency repetitive dTMS treatment with cue. Stimulation will be performed 3 times per week, for 5 weeks (15 treatments). In this group, stimulation will be performed with the following features: Intensity of stimulation: 120% of the resting Motor Threshold (rMT), Frequency: 18 Hz, Duration of the train: 2 sec, Inter-train interval: 20 sec, Trains number: 80, Total pulses: 2880, Total treatment duration: 29.3 min, Cue (sight of food preferred by patient): present.

Treatment:

Device: High frequency repetitive dTMS

High frequency repetitive dTMS - No Cue

Experimental group

Description:

10 obese individuals fulfilling all inclusion/exclusion criteria for the study will be randomized to active high frequency repetitive dTMS treatment without cue. Stimulation will be performed 3 times per week, for 5 weeks (15 treatments). In this group, stimulation will be performed with the following features: Intensity of stimulation: 120% of the resting Motor Threshold (rMT), Frequency: 18 Hz, Duration of the train: 2 sec, Inter-train interval: 20 sec, Trains number: 80, Total pulses: 2880, Total treatment duration: 29.3 min, Cue (sight of food preferred by patient): absent.

Treatment:

Device: High frequency repetitive dTMS

Low frequency repetitive dTMS+ Cue

Experimental group

Description:

10 obese individuals fulfilling all inclusion/exclusion criteria for the study will be randomized to active low frequency repetitive dTMS treatment with cue. Stimulation will be performed 3 times per week, for 5 weeks (15 treatments). In this group, stimulation will be performed with the following features: Intensity of stimulation: 120% of the resting Motor Threshold (rMT) Frequency: 1 Hz Duration of the train: 10 min Inter-train interval: 1 min Trains number: 4 Total pulses: 2400 Total treatment duration: 43 min Cue (sight of food preferred by patient): present

Treatment:

Device: Low frequency repetitive dTMS

Low frequency repetitive dTMS - No Cue

Experimental group

Description:

10 obese individuals fulfilling all inclusion/exclusion criteria for the study will be randomized to active low frequency repetitive dTMS treatment without cue. Stimulation will be performed 3 times per week, for 5 weeks (15 treatments). In this group, stimulation will be performed with the following features: Intensity of stimulation: 120% of the resting Motor Threshold (rMT), Frequency: 1 Hz, Duration of the train: 10 min, Inter-train interval: 1 min, Trains number: 4, Total pulses: 2400, Total treatment duration: 43 min, Cue (sight of food preferred by patient): absent.

Treatment:

Device: Low frequency repetitive dTMS

Sham

Sham Comparator group

Description:

10 obese individuals fulfilling all inclusion/exclusion criteria for the study will be randomized to sham stimulation. Stimulation will be performed 3 times per week, for 5 weeks (15 treatments). In this group, stimulation will be performed with the following features: Intensity of stimulation: 120% of the resting Motor Threshold (rMT), Frequency: 18 Hz (50% of patients) and 1 Hz (50% of patients), Duration of the train: 2 sec or 10 min, Inter-train interval: 20 sec or 1 min, Trains number: 80 or 4, Total pulses: 2880 or 2400, Total treatment duration: 29.3 or 43 min, Cue (sight of food preferred by patient): present.

Treatment:

Device: Sham