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临床试验/NCT06945731
NCT06945731已完成不适用

The Effectiveness of Repetitive Transcranial Magnetic Stimulation for Weight Loss in Overweight and Obese Patients

Larissa University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Food Craving

研究概览

简要总结

This doctoral dissertation takes into account epidemiological and clinical data of the international literature about obesity and, generally, increased body weight (BMI≥ 25kg/m2) and their consequences on health. Obesity management challenges many specialties, while, currently, the approved therapeutic methods are dietary intervention, various drugs and, in severe cases, bariatric surgery. All of the above methods show some degree of recurrence, while surgery carries the risk of serious complications.

Repetitive transcranial magnetic stimulation (rTMS) is classified into non-invasive brain stimulation methods and utilizes magnetic pulses generated by a coil to bring about changes in the brain. The method has already been approved for the treatment of some disorders, while it seems to help in the fight against many more psychiatric and neurological, mainly, diseases. The aim of the research will be to investigate the effectiveness of TMS in reducing body weight in participants with BMI≥ 25kg/m2.

The doctoral dissertation will study the reduction of BMI in obese and overweight patients and the variation of this reduction depending on the severity of obesity and age. In addition, it will investigate the effectiveness by setting as a parameter the observance of a diet. It will also record and statistically process the improvement of symptoms in the spectrum of some psychiatric disorders (eg depressive and psychotic symptoms, psychosomatic disorders).

The participants in the research will be hospitalized patients of the Psychiatric Clinic of the University General Hospital of Larissa (PGNL) and citizens. Clearly, patients from other clinics or other citizens can also participate in the research, provided they have a BMI≥ 25kg/m2. They will undergo 20 rTMS sessions (4 per week, for 5 weeks) and an assessment of BMI and some psychiatric symptoms before the start, at the end, 4 weeks after and 6 months after the end of the sessions. The rTMS will be applied to the left dorsal prefrontal cortex (left DLPFC), with an 8-coil in the following conditions: frequency 10 Hz, 75 4-second trains with 26-second intertrain interval, at 120% of the threshold for motor cortex activation. Participants will be divided into three groups: those who will not receive TMS, those who will receive sham TMS and those who will receive active TMS. These patients will then be compared with each other to answer the research questions. The therapeutic protocol presented is based on the international literature, while it presents positive results in the studies in which it has been applied.

Prerequisites for participation in the study are patient consent and BMI≥ 25kg/m2. In order to receive TMS, the patient first needs to agree and clarify that he / she does not have an individual or family history of seizures and that he / she does not have a cochlear implant. If the patient wishes, he can withdraw from the study at any stage. In addition to seizures, other side effects of treatment include headache and hearing loss (for which the patient will use earplugs).

The present dissertation will contribute to the further understanding of the mechanisms of obesity as well as the development of new therapies for the treatment of the disease.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age over 18 years
  • •BMI > 25 kg/m²
  • •Ability to provide written consent

排除标准

  • •History of epilepsy
  • •Active alcohol or substance abuse
  • •Severe active health condition
  • •Cochlear implants
  • •Inability to provide written consent
  • •BMI < 25 kg/m²
  • •Age under 18 years

研究组 & 干预措施

Active

Active Comparator

干预措施: TMS (Device)

Sham

Sham Comparator

干预措施: Transcranial Magnetic Stimulation Sham (Device)

结局指标

主要结局

Food Craving

时间窗: From enrollment to the end of the treatment at 5 weeks, follow up of 1 month and 6 months

Scale: Food Cravings Questionnaire-Trait Scores: 15-90 Higher score means worsening of symptoms

BMI

时间窗: From enrollment to the end of the treatment at 5 weeks, follow up of 1 month and 6 months

次要结局

  • Depressive Symptoms(From enrollment to the end of the treatment at 5 weeks, follow up of 1 month and 6 months)
  • Anxiety symptoms(From enrollment to the end of the treatment at 5 weeks, follow up of 1 month and 6 months)
  • Psychosomatic symptoms(From enrollment to the end of the treatment at 5 weeks, follow up of 1 month and 6 months)

研究者

发起方
Larissa University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nikolaos Liaskopoulos

MD

Larissa University Hospital

研究点 (1)

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