The Effectiveness of rTMS on Improving Food Craving and Weight Control in Adults Without Serious Mental Illness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Healthy adults
Aged between 18-65
Self-reported food craving or weight control issues
Disqualifiers
People with serious mental illness
Severe neurological conditions
Contraindications for rTMS
People on weight-reduction medications
Trial design
Design model
Single group
Treatments tested in this trial
repetitive transcranial magnetic stimulation
DeviceSix 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: healthy adultsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Food Cravings Questionnaire-Trait (FCQ-T)
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.
Time frame
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 interventionSecondary outcomes
1
Perceived Stress Scale (PSS)
Using perceived stress scale (PSS) to evaluate perceived stress levels. First, reverse the scores for questions 4, 5, 7, and 8. On these 4 questions, change the scores like this: 0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0. Now add up the scores for each item to get a total. The total score is \_\_\_\_\_\_\_\_\_\_\_. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress
Time frame
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 intervention2
Patient Health Questionnaire-9 (PHQ-9)
Using Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms Scoring: add up all checked boxes on PHQ-9 (For every 3 Not at all = 0; Several days = 1; More than half the days = 2; Nearly every day = 3) Interpretation of Total Score: Total Score Depression Severity 1-4: Minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression
Time frame
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 intervention3
BMI
Using BMI to measure the objective weight changes in between pre and post intervention. To calculate Body Mass Index (BMI), divide participants' weight in kilograms by the square of participants' height in meters
Time frame
Baseline: the day the rTMS intervention starts Post-intervention: the day the last session rTMS interventionSponsors and contacts
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Source ClinicalTrials.gov