Using magnetic stimulation to reduce food cravings in obesity patients

Can Transcranial Magnetic Stimulation Decrease Food Reinforcement Among Surgical Weight Loss-Seeking Adults Who Have High Levels of Hedonic Hunger and Responsivity to Food Cues

This study is testing if a special brain treatment can help people who are overweight and planning to have weight loss surgery by reducing their cravings for food.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Hartford Hospital (other)
• Locations: 1 site (Hartford, Connecticut)
• Trial ID: NCT05522803 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on patients seeking bariatric surgery, specifically targeting those who exhibit high levels of hedonic hunger and disinhibition. The approach involves administering rTMS to modulate brain reward circuitry, potentially decreasing the reinforcing properties of food. Participants will undergo sessions of TMS followed by sham TMS and vice versa to assess the efficacy of this intervention. The goal is to enhance the outcomes of bariatric surgery by addressing neural mechanisms that contribute to overeating.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 who are seeking primary bariatric surgery and exhibit characteristics of hedonic hunger.

Not a fit: Patients with a history of neurological disorders or those at increased risk for seizures may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve weight loss outcomes for bariatric surgery patients by reducing cravings and overeating behaviors.

How similar studies have performed: While the use of rTMS in this context is relatively novel, previous studies have shown promise in targeting brain reward pathways for various conditions.

Eligibility criteria

Inclusion Criteria:

1. Seeking to undergo primary (not revisional) bariatric surgery at HH.
2. Be able to give valid informed consent in English.
3. Be 18-60 years of age.
4. Absence of cognitive impairment. Must score below 17 on the adult ADHD self-report scale and have an IQ equivalent of ≥ 80 on the WRAT.
5. Meet clinical criteria regarding hedonic hunger
6. Meet safety criteria for EEG and rTMS.
7. Eat a typical breakfast before 8:00 AM on the day of screening.

Exclusion Criteria:

1. History of any neurological disorder that would increase seizure risk from rTMS such as stroke, brain lesions, previous neurosurgery, any history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month.
2. First-degree family history of epilepsy, schizophrenia, and bipolar disorder, neurological disorders with a potentially hereditary basis that affect rTMS safety or EEG measures.
3. Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes rTMS administration.
4. Noise-induced hearing loss or tinnitus.
5. Current use of any investigational drug or of anti or pro-convulsive action. Use of medications with psychotropic (e.g., benzodiazepines) effects that is not currently stabilized or with disease symptoms present.
6. Lifetime history of schizophrenia, bipolar disorder, mania, or hypomania.
7. History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, and currently under medical care.
8. Participation in any rTMS session less than 2 weeks prior to admission. No rTMS exposure for treatment purposes in the last 6 months.
9. Pregnant women.

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Where this trial is running

Hartford, Connecticut

• Hartford Hospital — Hartford, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Dale Bond, PhD — Hartford HealthCare
• Study coordinator: Dale Bond, PhD

Conditions: Obesity