Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT06105164

Conditions

Appetitive Behavior

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham repetitive Transcranial Magnetic Stimulation (rTMS)

Study Details

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.

Conditions

Appetitive Behavior

Obesity

Study ID

NCT06105164

Start date

Dec 5, 2024

Status verified date

Dec, 2025

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Active cerebellar rTMS

Cerebellar targeted iTBS

sham comparator: Sham cerebellar rTMS

Cerebellar targeted sham iTBS

Interventions

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.

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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Laura Holsen, PhD

617-525-8772lholsen@bwh.harvard.edu

Mark Halko, PhD

617-855-2415mhalko@mclean.harvard.edu

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Mark Halko, PhD

617-855-2415mhalko@mclean.harvard.edu

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02120

Contacts

Laura Holsen, PhD

617-525-8772lholsen@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-12-05.