Appetitive BehaviorNCT06105164
Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Appetitive Behavior and Obesity, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior, Obesity
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Dec 2024to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Current nicotine use
- Intellectual disability
- Conditions that might result in increased risks of side effects or complications from TMS or MRI
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
Mark Halko, PhD, 617-855-2415, mhalko@mclean.harvard.edu
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02120
Laura Holsen, PhD, 617-525-8772, lholsen@bwh.harvard.edu
About this study
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.
Read the 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.
- Conditions
- Appetitive Behavior, Obesity
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Sham repetitive Transcranial Magnetic Stimulation (rTMS)
- Medical subject headings
- Appetitive Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Also called iTBS
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
Also called iTBS
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 group | Role | What they receive |
|---|---|---|
| Active cerebellar rTMS | Active comparator | Cerebellar targeted iTBS Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Sham cerebellar rTMS | Sham comparator | Cerebellar targeted sham iTBS Receives: Device: Sham repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, up to 60 minutes post-TMS at each of two main study visits (fed, fasted)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start5 Dec 2024
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mclean Hospital, Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Laura M Holsen, Brigham and Women's Hospital
- Investigators
- Laura Holsen, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105164
- Sponsor's protocol ID
- 2023P002811
- Status last verified
- Dec 2025
- First submitted
- 19 Oct 2023
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Deidentified participant data will be shared with NIMH Data Repository (NDA).
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans
- ClinicalTrials.gov ID
- NCT06105164
- Acronym / sponsor ID
- 2023P002811
- Conditions
- Appetitive Behavior, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Mclean Hospital, Beth Israel Deaconess Medical Center
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active cerebellar rTMS | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Cerebellar targeted iTBS |
| Sham cerebellar rTMS | Sham comparator | Device: Sham repetitive Transcranial Magnetic Stimulation (rTMS)Cerebellar targeted sham iTBS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)Also: iTBSrTMS 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. | Device | Active cerebellar rTMS |
| Sham repetitive Transcranial Magnetic Stimulation (rTMS)Also: iTBSrTMS 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. | Device | Sham cerebellar rTMS |
Primary outcome
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 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.
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 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.
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)
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.
Ad libitum snack food intake
Time frame: baseline, up to 60 minutes post-TMS at each of two main study visits (fed, fasted)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No. Deidentified participant data will be shared with NIMH Data Repository (NDA).
Related trials for Appetitive Behavior
Active, not recruitingObservational study
Appetitive Conditioning in Anorexia Nervosa
Anorexia Nervosa
Recruiting
Behavioral Approach for Latinas Addressing Nutrition, Cravings, and Eating Patterns to Prevent Type 2 Diabetes
Prediabetes, Obesity (Body Mass Index >30 kg/m2)
Recruiting
Exercise, Brain Activity, and Weight Maintenance
Obesity, Weight Gain
RecruitingPhase 4
Metabolic and Behavioural Effects of CONTRAVE as Potential Mechanisms of Weight Loss in Adults With Obesity
Obesity, Weight Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Holsen, PhD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Appetitive Behavior and Obesity, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Holsen, PhD (617-525-8772, lholsen@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.