Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans
NCT ID: NCT06105164
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-12-05
2029-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Active cerebellar rTMS
Cerebellar targeted iTBS
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 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 cerebellar rTMS
Cerebellar targeted sham iTBS
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 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.
Interventions
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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 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)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
Yes
Sponsors
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Mclean Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Laura M Holsen
Associate Professor of Psychiatry
Principal Investigators
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Laura Holsen, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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McLean Hospital
Belmont, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023P002811
Identifier Type: -
Identifier Source: org_study_id
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