Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06105164
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 5, 2024
Status verified
Dec 2025
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Active cerebellar rTMS
    Cerebellar targeted iTBS
  • Sham Comparator: Sham cerebellar rTMS
    Cerebellar targeted sham iTBS

Primary Outcome Measure

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) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478
Mark Halko, PhD
[email protected]
617-855-2415
Brigham and Women's HospitalBostonMassachusetts02120
Laura Holsen, PhD
[email protected]
617-525-8772

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