NCT06105164

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
40mo left

Started Dec 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Dec 2024Aug 2029

First Submitted

Initial submission to the registry

October 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 5, 2024

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

4.7 years

First QC Date

October 19, 2023

Last Update Submit

December 1, 2025

Conditions

Appetitive BehaviorObesity

Outcome Measures

Primary Outcomes (4)

  • Change in BOLD response in the cerebellum

    Change in functional activation of the cerebellum will be assessed before (pre-TMS) and after (post-rTMS) rTMS stimulation, measured separately at the fed visit and at the fasted visit.

    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

    Change in functional activation of the ventral striatum will be assessed before (pre-TMS) and after (post-rTMS) rTMS stimulation, measured separately at the fed visit and at the fasted visit.

    30 minutes pre-TMS and 30 minutes post-TMS, at each of two main study visits (fed, fasted)

  • Change in food reward valuation

    Change in food reward valuation of high-calorie foods will be assessed using the Willingness to Pay task, measured before (pre-TMS) and after (post-rTMS) rTMS stimulation, measured separately at the fed visit and at the fasted visit.

    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

    Change in total caloric intake during the ad libitum snack food session will be assessed at the baseline visit and after (post-rTMS) rTMS stimulation, the latter measured separately at the fed visit and at the fasted visit.

    baseline, up to 60 minutes post-TMS at each of two main study visits (fed, fasted)

Study Arms (2)

Active cerebellar rTMS

ACTIVE COMPARATOR

Cerebellar targeted iTBS

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham cerebellar rTMS

SHAM COMPARATOR

Cerebellar targeted sham iTBS

Device: Sham repetitive Transcranial Magnetic Stimulation (rTMS)

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.

Also known as: iTBS
Active cerebellar rTMS
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.

Also known as: iTBS
Sham cerebellar rTMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

RECRUITING

MeSH Terms

Conditions

Appetitive BehaviorObesity

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Laura Holsen, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Holsen, PhD

CONTACT

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

Mark Halko, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 27, 2023

Study Start

December 5, 2024

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Deidentified participant data will be shared with NIMH Data Repository (NDA).

Locations

US(2)