Clinical trial NCT06105164: Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans
Official title: Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Appetitive Behavior
Obesity
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Mclean Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2023-10-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in BOLD response in the cerebellum
timeFrame: 30 minutes pre-TMS and 30 minutes post-TMS, at each of two main study visits (fed, fasted)
measure: Change in BOLD response in the ventral striatum
timeFrame: 30 minutes pre-TMS and 30 minutes post-TMS, at each of two main study visits (fed, fasted)
measure: Change in food reward valuation
timeFrame: up to 60 minutes pre-TMS and up to 60 minutes post-TMS, at each of two main study visits (fed, fasted)
measure: Ad libitum snack food intake
timeFrame: baseline, up to 60 minutes post-TMS at each of two main study visits (fed, fasted)
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Laura Holsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: