Impact of Deep Transcranial Magnetic Stimulation (dTMS) on Satiety and Weight Control
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in food craving levels induced by repetitive dTMS from baseline at 5 weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Urine drug screen positive for amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates and phencyclidine
- •Positivity to blood alcohol test
- •Metal in any part of the head, except for dental fillings
- •Implanted infusion pumps
- •Intracardiac devices (pacemakers, heart valves ...)
- •History of diseases whose exacerbation could be fatal (e.g. cardiovascular disease, increased intracranial pressure)
- •History of epilepsy or a family history of epilepsy among first-degree relatives
- •Medications associated with lowered seizure threshold (such as antidepressants, anxiolytics...)
- •Treatment with anti-obesity medications or other medications influencing body weight within 3 month prior to Screening Visit
- •Starting a weight loss plan at any time during data collection for the subject
- •Patients affected by galactosemia, priapism and terminal illness
- •Patients on fluid restriction for SIADH or other conditions
- •Contraindications to perform the Magnetic Resonance Imaging (MRI).
研究组 & 干预措施
High frequency repetitive dTMS + Cue
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.
干预措施: High frequency repetitive dTMS (Device)
High frequency repetitive dTMS - No Cue
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.
干预措施: High frequency repetitive dTMS (Device)
Low frequency repetitive dTMS+ Cue
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
干预措施: Low frequency repetitive dTMS (Device)
Low frequency repetitive dTMS - No Cue
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.
干预措施: Low frequency repetitive dTMS (Device)
Sham
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.
干预措施: Sham (Device)
结局指标
主要结局
Changes in food craving levels induced by repetitive dTMS from baseline at 5 weeks
时间窗: Baseline and end of treatment (5 weeks)
Food craving will be evaluated by the Food Cravings Questionnaire-Trait (FCQ-T), a self-report multidimensional questionnaire composed of 39 items aimed to investigate food addiction and eating disorders. Total FCQ-T score will be used as a general measure of trait craving; individual FCQ-T scores related to the 9 measured craving dimensions could be useful in identifying and differentiating craving profiles between specific populations. Food craving will be also evaluated at follow-up visit 1 (1 month after the end of treatment), follow-up visit 2 (6 months after the end of treatment), and follow-up visit 3 (1 year after the end of treatment).
次要结局
- Changes in body weight induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Changes in Fat Mass (FM) rate induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Acute and chronic changes in insulin levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Acute and chronic changes in glucagon levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Acute and chronic changes in ghrelin levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Acute and chronic changes in leptin levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Acute and chronic changes in Growth Hormone (GH) levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Acute and chronic changes in Adreno-Cortico-Tropic Hormone (ACTH) levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Acute and chronic changes in Thyroid-Stimulating Hormone (TSH) levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Acute and chronic changes in Prolactin levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Acute and chronic changes in Cortisol levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Acute and chronic changes in Neuropeptide Y levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Changes in Beta-endorphin levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Changes in Epinephrine levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Changes in Norepinephrine levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Changes in Glucose levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Changes in Glycated Hemoglobin levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Changes in Cholesterol levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
- Changes in Triglyceride levels induced by repetitive dTMS from baseline at 5 weeks(Baseline and end of treatment (5 weeks))
研究者
Anna Ferrulli
M.D., Ph.D, Sub-Investigator
Ospedale San Donato