Validation of a Novel Cerebellar-striatal Satiety Circuit in Humans
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy individuals aged 18 to 65
BMI of 20-35.0 kg/m2
Normal or corrected-to-normal vision
Good general health
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Repetitive Transcranial Magnetic Stimulation (rTMS)
DevicerTMS 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)
DevicerTMS 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Active cerebellar rTMSActive comparator 1 intervention
Group B: Sham cerebellar rTMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
30 minutes pre-TMS and 30 minutes post-TMS, at each of two main study visits (fed, fasted)2
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.
Time frame
30 minutes pre-TMS and 30 minutes post-TMS, at each of two main study visits (fed, fasted)3
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.
Time frame
up to 60 minutes pre-TMS and up to 60 minutes post-TMS, at each of two main study visits (fed, fasted)4
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.
Time frame
baseline, up to 60 minutes post-TMS at each of two main study visits (fed, fasted)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
Mclean Hospital
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Source ClinicalTrials.gov