Resting State Changes Following Theta Burst Stimulation
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Nicholas Balderston, PhD
- Study ID
- NCT05322239
- Status
- Recruiting
Conditions
- Brain Connectivity
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- Intermittent Theta Burst Stimulation — DEVICEiTBS parameters. A series of 20, 10 s trains will be presented over the course of the \~3.5 min session. Each train will consist of 2 s of stimulation with an 8 s ITI. During the 2 s of stimulation, 10, 50 Hz bursts will be repeated at intervals of 200 ms (5 Hz).
- Continuous Theta Burst Stimulation — DEVICEcTBS parameters. A single 600 pulse cTBS train will be delivered during each stimulation session. The train will consist of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec.
Study Details
Transcranial magnetic stimulation (TMS) is increasingly being applied to effectively treat mental illness, however efforts to quantify the effects of TMS on the network architecture of the brain have largely been limited in scope and tied to specific neurologic and psychiatric disorders. The objective of the current work is to build and validate a whole-brain, domain-general model of brain connectivity changes following TMS, based on physical models of the current distribution at the cortex. PUBLIC HEALTH RELEVANCE: This work is relevant to public health because it will provide direct evidence that brain connectivity changes following neuromodulatory TMS vary as a function of the current density at the cortex, which can be used to predict psychiatric symptom change following neuromodulatory TMS.
Key Dates
- Start date
- Nov 17, 2022
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2026
- Completion
- Aug 1, 2027
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Intermittent Theta Burst StimulationTBS. A Magventure MagPro 100X stimulator with a B65 figure-8 coil will be used for the TBS sessions. On each of the 3 stimulation days, 5 iTBS sessions will be administered at 30 min intervals.
- Experimental: Continuous Theta Burst StimulationTBS. A Magventure MagPro 100X stimulator with a B65 figure-8 coil will be used for the TBS sessions. On each of the 3 stimulation days, 5 cTBS sessions will be administered at 30 min intervals.
Primary Outcome Measure
Resting state - dose 1 [ Time Frame: 24 hours ]
Central Contacts
- Nicholas L Balderston2157463058
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 |