rTMS for Obesity

Recruiting at 1 trial location

Overseen By Mark Halko, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Weight loss medications

Disqualifiers: Eating disorder, Bariatric surgery, Nicotine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how repetitive transcranial magnetic stimulation (rTMS) affects feelings of fullness, or satiety, in healthy individuals. rTMS uses magnetic fields to stimulate the brain, with this study focusing on the cerebellum. Researchers compare the effects of real rTMS with a sham version to understand its impact. Individuals who are generally healthy, have a BMI between 20 and 35, and are not dealing with eating disorders or taking weight loss medications might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to foundational research and explore new frontiers in brain stimulation techniques.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those taking weight loss medications.

What prior data suggests that this technique is safe for studying satiety?

Research has shown that repetitive Transcranial Magnetic Stimulation (rTMS) is generally safe. Studies have used rTMS safely to help manage body weight and reduce appetite in individuals with obesity. Participants often report few side effects. When side effects occur, they are usually mild, such as headaches or discomfort where the magnetic coil touches the scalp. This suggests that rTMS is a safe method to study how the brain might control feelings of fullness or satisfaction after eating. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about repetitive Transcranial Magnetic Stimulation (rTMS) for obesity because it offers a non-invasive approach that targets the brain's cerebellum, which may play a role in regulating appetite and body weight. Unlike current obesity treatments that often focus on diet, exercise, or medication, rTMS uses magnetic fields to stimulate specific brain areas, potentially altering neural pathways associated with hunger and satiety. This unique mechanism could provide a novel way to manage obesity, especially for those who haven't found success with traditional methods.

What evidence suggests that rTMS is effective for studying satiety in healthy individuals?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) can aid weight loss in people with obesity. In this trial, participants will receive either active cerebellar rTMS or sham cerebellar rTMS. Studies have found that after rTMS treatment, participants experienced a noticeable drop in body weight and body mass index (BMI). They also lost fat, particularly in the belly area. Additionally, rTMS has been linked to reduced food intake and improved control over impulsive eating. These findings suggest that rTMS might help manage weight by influencing brain activity related to hunger and satiety. ^{2 4 5 6 7}

Who Is on the Research Team?

Laura Holsen, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 18 to 65 with a BMI of 20-35, who have normal vision (or corrected-to-normal) and are in good general health. Participants must understand and agree to the study's consent form. Those with medical conditions, drug abuse history, nicotine use, eating disorders, recent weight fluctuations or on diets/weight loss meds cannot join.

Inclusion Criteria

My vision is normal or corrected to normal with glasses or contacts.

Ability to understand and willingness to sign written informed consent document

I am in good health overall.

Exclusion Criteria

I am on a special diet or taking medication to lose weight.

You have recently used illegal drugs for fun.

I have a history of medical conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including physical activity, food craving, and an MRI scan

1 week

1 visit (in-person)

Treatment

Participants complete two testing sessions involving MRI imaging and food intake assessments before and after rTMS

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in BOLD response and food reward valuation post-treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)
• Sham repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview The study tests how noninvasive brain stimulation using transcranial magnetic stimulation (TMS) affects feelings of fullness. It compares real TMS targeting the cerebellum against sham (fake) treatment to understand its role in controlling compulsive eating and obesity.

How Is the Trial Designed?

Group I: Active cerebellar rTMS Active Control 1 Intervention

Cerebellar targeted iTBS

Group II: Sham cerebellar rTMS Placebo Group 1 Intervention

Cerebellar targeted sham iTBS

Repetitive Transcranial Magnetic Stimulation (rTMS) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as rTMS for:

• Depression
• Smoking cessation

Approved in European Union as rTMS for:

• Depression

Approved in Canada as rTMS for:

• Depression

Approved in Japan as rTMS for:

• Depression

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Mclean Hospital

Collaborator

Trials

221

Recruited

22,500+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

In a study of 63 obese individuals undergoing a 5-week rTMS treatment for weight control, the treatment showed a reassuring safety profile with no unexpected adverse events reported up to one year after treatment.

The most common side effects were moderate headaches (40.4%) and local pain/discomfort (19.2%), particularly more frequent in the high-frequency rTMS group, but overall, rTMS was well tolerated in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. Ferrulli, A., Massarini, S., Macrì, C., et al.[2021]

In a 4-week study involving 43 obese adults, 8 sessions of repetitive transcranial magnetic stimulation (rTMS) significantly reduced body weight by an average of 2.75 kg compared to a control group, which saw minimal weight change.

Participants receiving rTMS also experienced a notable decrease in fat mass and visceral fat, along with reduced daily calorie and carbohydrate intake, indicating that rTMS may effectively help manage obesity by influencing both weight and eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of repetitive transcranial magnetic stimulation on body weight and food consumption in obese adults: A randomized controlled study. Kim, SH., Chung, JH., Kim, TH., et al.[2020]

Repetitive transcranial magnetic stimulation (rTMS) has shown promise in reducing food cravings, which may help in treating obesity linked to eating disorders, particularly bulimia nervosa.

While rTMS appears to be a safe and non-invasive option, more extensive studies with larger participant groups are necessary to fully understand its effectiveness in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential role of repetitive transcranial magnetic stimulation in obesity. Bou Khalil, R., El Hachem, C.[2021]

In a 4-week study involving 36 adults with obesity, high-frequency rTMS targeting the left dorsolateral prefrontal cortex led to a significant weight loss of approximately 2.53 kg compared to a negligible weight change in the sham group.

The treatment also enhanced functional connectivity in the right frontoparietal network, which is associated with controlling food intake, suggesting that rTMS may help improve the brain's ability to regulate eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of high-frequency repetitive transcranial magnetic stimulation on resting-state functional connectivity in obese adults. Kim, SH., Park, BY., Byeon, K., et al.[2020]

The RESTRAIN study is the first to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) on reducing the reinforcing value of food in patients pursuing metabolic and bariatric surgery (MBS), aiming to improve their eating behaviors and outcomes.

With 17 participants enrolled, the study will compare active rTMS to sham rTMS to see if it can effectively decrease cravings for palatable foods and enhance brain reward processing, potentially leading to healthier eating patterns post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation for Reducing the Relative Reinforcing Value of Food in Adult Patients With Obesity Pursuing Metabolic and Bariatric Surgery: Protocol for a Pilot, Within-Participants, Sham-Controlled Trial. Bond, DS., Papasavas, PK., Raynor, HA., et al.[2023]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29326022/

The effects of repetitive transcranial magnetic stimulation on ... Consistent with weight loss, there was a significant reduction in BMI, fat mass and VAT at week 4 in the rTMS group compared with the control group (p < 0.05).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7784228/

Efficacy of Repetitive Transcranial Magnetic Stimulation ... Results showed that at the 4th week, participants who received rTMS showed a significant weight loss from baseline after 4 sessions (-1.35±2.31 kg vs 0.45±1.28 ...

3. openneurologyjournal.com openneurologyjournal.com/VOLUME/18/ELOCATOR/e1874205X309047/FULLTEXT/

Transcranial Magnetic Stimulation: A New Possibility in ... The study found that the HF group showed a significant reduction in body weight and BMI, along with a decrease in impulsivity levels.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X17310021

The effects of repetitive transcranial magnetic stimulation ... We found that HF rTMS delivered to the left DLPFC showed weight loss and reduced food intake in people with obesity.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03009695

Transcranial Magnetic Stimulation (TMS) in Obesity The use of repetitive deep Transcranial Magnetic Stimulation (dTMS) was proposed to reduce appetite and food craving in obese subjects, leading eventually to a ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32964308/

Safety and tolerability of repeated sessions of deep ... Repetitive Transcranial Magnetic Stimulation (rTMS) has been demonstrated to be effective in body weight control in individuals with obesity.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7881959/

Safety and tolerability of repeated sessions of deep ... Repetitive Transcranial Magnetic Stimulation (rTMS) has been demonstrated to be effective in body weight control in individuals with obesity.