Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans

Mass General Brigham

Status: Enrolling

Conditions: Appetitive Behavior; Obesity

Treatments: Device: Sham repetitive Transcranial Magnetic Stimulation (rTMS); Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06105164

2023P002811

Details and patient eligibility

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.

Full description

The purpose of this study is to conduct a circuit manipulation experiment to test the hypothesis that targeting the cerebellum can alter activity in response to food cues to advance the understanding of the involvement of the cerebellar-striatal circuit in feeding behavior.

Participants will undergo an initial screening session to complete informed consent and undergo baseline assessments including physical activity and food craving. Participants will additionally undergo an MRI scan that includes structural and resting-state functional magnetic resonance imaging (rsfMRI). These rsfMRI imagines will be used to isolate individual resting state networks for targeting of rTMS modulation.

Participants will then complete two separate testing sessions involving MRI imaging and food intake assessments before and after rTMS. One visit will involve consumption of a filling meal; the other visit will be completed following an overnight fast.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Active cerebellar rTMS

Active Comparator group

Description:

Cerebellar targeted iTBS

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham cerebellar rTMS

Sham Comparator group

Description:

Cerebellar targeted sham iTBS

Treatment:

Device: Sham repetitive Transcranial Magnetic Stimulation (rTMS)