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Recruiting NCT06105164

Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans

No phase Interventional Appetitive Behavior Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repetitive Transcranial Magnetic Stimulation (rTMS), Sham repetitive Transcranial Magnetic Stimulation (rTMS).
Who it may be relevant to
Registry conditions: Appetitive Behavior, Obesity. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Device Repetitive Transcranial Magnetic Stimulation (rTMS)
    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 60
  • Device Sham repetitive Transcranial Magnetic Stimulation (rTMS)
    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 60

Primary outcome measures

  • Change in BOLD response in the cerebellum [Time frame: 30 minutes pre-TMS and 30 minutes post-TMS, at each of two main study visits (fed, fasted)]
  • Change in BOLD response in the ventral striatum [Time frame: 30 minutes pre-TMS and 30 minutes post-TMS, at each of two main study visits (fed, fasted)]
  • Change in food reward valuation [Time frame: up to 60 minutes pre-TMS and up to 60 minutes post-TMS, at each of two main study visits (fed, fasted)]
  • Ad libitum snack food intake [Time frame: baseline, up to 60 minutes post-TMS at each of two main study visits (fed, fasted)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

United States · 2 centers
  • McLean Hospital — Belmont
  • Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT06105164 · 2023P002811

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗