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

Trial Summary

What is the purpose of this trial?

This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study satiety in healthy individuals. TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study, the investigators will be stimulating the brain to learn more about the role of the cerebellum in satiety.

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 data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS) for obesity?

Research suggests that rTMS can help control body weight in people with obesity and may reduce food cravings, which are often linked to overeating. Additionally, rTMS has shown promise in treating eating disorders, which can contribute to obesity. ^{1 2 3 4 5}

Is rTMS safe for use in humans?

Repetitive Transcranial Magnetic Stimulation (rTMS) is generally considered safe, with most studies showing a reassuring safety profile and only mild side effects. Safety guidelines have been established and updated over the years to ensure its safe application in both healthy individuals and those with various conditions. ^{1 2 3 4 6}

How is the treatment rTMS unique for obesity?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique for obesity as it is a non-invasive treatment that uses magnetic fields to stimulate specific areas of the brain, potentially reducing food cravings and improving eating behaviors, unlike traditional weight loss methods that often focus on diet and exercise. ^{1 2 3 4 5}

Research Team

Laura Holsen, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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.

You are currently using nicotine products like cigarettes or e-cigarettes.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. United States 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The effects of high-frequency repetitive transcranial magnetic stimulation on resting-state functional connectivity in obese adults. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Potential role of repetitive transcranial magnetic stimulation in obesity. [2021]

5. Canada 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. [2023]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]