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Clinical trial

Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans

Recruiting now · Not applicable · 1 countries · Registry ID NCT06105164

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionAppetitive Behavior, Obesity

Full registry criteria

Inclusion Criteria: * Healthy individuals aged 18 to 65 * BMI of 20-35.0 kg/m2 * Normal or corrected-to-normal vision * Good general health * Ability to understand and willingness to sign written informed consent document Exclusion Criteria: * Current and/or past medical conditions * Current and/or past eating disorder * On a restricted diet and/or taking weight loss medication(s) * History of bariatric surgery * Weight fluctuation \>3% in past 3 months * Recent history of illicit recreational drug abuse * Current nicotine use * Intellectual disability * Conditions that might result in increased risks of side effects or complications from TMS or MRI

Treatments and study arms

Repetitive Transcranial Magnetic Stimulation (rTMS)

Device

rTMS is a technique of TMS that allows for selective external manipulation of neural activity in a non-invasive manner. During rTMS a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field, which in turn induces electrical current in neurons and allows for modulation of neural circuitry. Intermittent theta burst stimulation (iTBS) consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses (82), will be applied to the target. Cerebellar stimulation will be applied to the targets at 100% of aMT or 35% maximal stimulator output, whichever is higher.

Sham repetitive Transcranial Magnetic Stimulation (rTMS)

Device

rTMS is a technique of TMS that allows for selective external manipulation of neural activity in a non-invasive manner. During rTMS a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field, which in turn induces electrical current in neurons and allows for modulation of neural circuitry. Intermittent theta burst stimulation (iTBS) consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses (82), will be applied to the target. Cerebellar stimulation will be applied to the targets at 100% of aMT or 35% maximal stimulator output, whichever is higher. Sham is achieved by using a coil with a magnetic shield preventing magnetic field from reaching the head.

Primary outcomes

Change in BOLD response in the cerebellum30 minutes pre-TMS and 30 minutes post-TMS, at each of two main study visits (fed, fasted)

Change in functional activation of the cerebellum will be assessed before (pre-TMS) and after (post-rTMS) rTMS stimulation, measured separately at the fed visit and at the fasted visit.

Change in BOLD response in the ventral striatum30 minutes pre-TMS and 30 minutes post-TMS, at each of two main study visits (fed, fasted)

Change in functional activation of the ventral striatum will be assessed before (pre-TMS) and after (post-rTMS) rTMS stimulation, measured separately at the fed visit and at the fasted visit.

Change in food reward valuationup to 60 minutes pre-TMS and up to 60 minutes post-TMS, at each of two main study visits (fed, fasted)

Change in food reward valuation of high-calorie foods will be assessed using the Willingness to Pay task, measured before (pre-TMS) and after (post-rTMS) rTMS stimulation, measured separately at the fed visit and at the fasted visit.

Ad libitum snack food intakebaseline, up to 60 minutes post-TMS at each of two main study visits (fed, fasted)

Change in total caloric intake during the ad libitum snack food session will be assessed at the baseline visit and after (post-rTMS) rTMS stimulation, the latter measured separately at the fed visit and at the fasted visit.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

McLean Hospital🇺🇸 Belmont, Massachusetts, United States
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Mark Halko, PhDContact
Email · Call 617-855-2415
Brigham and Women's Hospital🇺🇸 Boston, Massachusetts, United States
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Laura Holsen, PhDContact
Email · Call 617-525-8772