跳至主要内容
临床试验/NCT07106398
NCT07106398招募中不适用

The Effectiveness of rTMS on Improving Food Craving and Weight Control in Adults Without Serious Mental Illness

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Food Cravings Questionnaire-Trait (FCQ-T)

研究概览

简要总结

Department of Psychiatry | Li Ka Shing Faculty of Medicine

The University of Hong Kong

The Effectiveness of rTMS on Improving Food Cravings and Weight Control

in Adults without Serious Mental Illness

Introduction

The investigators would like to invite participants to participate in an observational study on the efficacy of using magnetic fields to improve food cravings and weight control in adults without serious mental illness.

The research leader is Dr. Cheng Pak Wing, Assistant Professor, Department of Psychiatry, Queen Mary Hospital/HKU Li Ka Shing Faculty of Medicine.

Please read the following information carefully. If necessary, participants can discuss it with relatives, friends or doctors. If anything is unclear, or if participants would like more information, please ask us. Please carefully consider whether participants are willing to participate in this research.

Research Purpose

Food cravings are a common experience that can significantly impact an individual's mental and physical health. These intense desires for specific foods often lead to overconsumption of unhealthy foods, contributing to obesity, poor nutritional intake, and associated health conditions. Understanding the neural mechanisms behind food cravings is crucial for developing effective interventions to manage them.

rTMS is a non-invasive brain stimulation technique that uses magnetic fields to modulate neural activity in targeted brain regions. Over the years, rTMS has shown promise in treating various mental health conditions, including depression, obsessive-compulsive disorder (OCD) and eating disorders.

Research Methods

Participants

Healthy adults aged 18-65 with self-reported food cravings or weight control issues.

Treatment protocol

Six sessions of rTMS using the EXOMIND™ device, administered once or twice a week.

Each session will deliver 6,300 pulses at alternating frequencies of 12, 15, and 18 Hz, with a total duration of 24 minutes and 30 seconds.

The target site would be left dorsolateral prefrontal cortex (DLPFC), determined by the most common used 5-cm rule. The procedure would be conducted in the research centre with medical staff supported.

A checklist of potential adverse effects from TMS administration will be referenced from existing literature to monitor tolerability and adverse events during each session. Blood pressure and heart rate will be recorded at the beginning and end of each session.

Assessment

Participants will be assessed at three time points: baseline (pre-intervention), post-intervention, and four weeks post-intervention.

Assessments: Food Cravings Questionnaire-Trait (FCQ-T), Perceived Stress Scale (PSS), Patient Health Questionnaire-9 (PHQ-9), and BMI.

Demographics: Age, gender, years of education, place of birth, marital status, number of children, financial condition, household income, family history of eating problems will be collected upon study entry. Medical history in relation to mental illnesses and medications will also be assessed.

详细描述

Risks of Participation

Participants may experience mild discomfort from brain stimulation treatment. A small percentage of users may experience dizziness, headache, or nausea. The side effects of brain pulse stimulation therapy are short-lived and are not known to cause any permanent damage. If participants feel unwell after completing the brain pulse stimulation treatment, please inform the staff and therapist.

Note: Patients who have had metal implants in the head, neck, or upper back, or who have had metal teeth/dental trays or pacemakers, should not receive brain stimulation.

Benefits of Participation

The investigators sincerely invite participants to participate in this study. The valuable information participants provide will help us understand the effect of using magnetic fields to improve food cravings or weight control issues in adults. All procedures involved in the study are provided free of charge.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Healthy adults
  • •Aged between 18-65
  • •Self-reported food craving or weight control issues

排除标准

  • •People with serious mental illness
  • •Severe neurological conditions
  • •Contraindications for rTMS
  • •People on weight-reduction medications

研究组 & 干预措施

healthy adults

Experimental

Healthy adults aged 18-65 Self-reported food craving or weight control issues

干预措施: repetitive transcranial magnetic stimulation (Device)

结局指标

主要结局

Food Cravings Questionnaire-Trait (FCQ-T)

时间窗: Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention

Using Food Cravings Questionnaire-Trait (FCQ-T) to measure level of food cravings. The questionnaire consists of 23 questions, participants are required to rate the frequency of each statement with a 6-likert scale. By summing up the scores of the scles, higher scores represent higher level of food cravings.

Food Cravings Questionnaire-Trait (FCQ-T)

时间窗: Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention

Using Food Cravings Questionnaire-Trait (FCQ-T) to measure level of food cravings. The questionnaire consists of 23 questions, participants are required to rate the frequency of each statement with a 6-likert scale. By summing up the scores of the scles, higher scores represent higher level of food cravings.

次要结局

  • Perceived Stress Scale (PSS)(Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention)
  • Patient Health Questionnaire-9 (PHQ-9)(Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention)
  • BMI(Baseline: the day the rTMS intervention starts Post-intervention: the day the last session rTMS intervention)
  • Perceived Stress Scale (PSS)(Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention)
  • Patient Health Questionnaire-9 (PHQ-9)(Baseline: 1-week before rTMS intervention starts Post-intervention: 1-week immediately after the last session of rTMS intervention 4-week post-intervention: 4-week after the last session of rTMS intervention)
  • BMI(Baseline: the day the rTMS intervention starts Post-intervention: the day the last session rTMS intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Cheng Pak Wing, Calvin

Clinical Assistant Professor

The University of Hong Kong

研究点 (1)

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