Effect of cTBS on Startle and TMS-evoked BOLD

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07415772
Status
Not Yet Recruiting

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Conditions

  • Anxiety

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Active TMS — DEVICE
    Subjects will receive a continuous 1800 pulse cTBS train to the right dlPFC at 100% of motor threshold. The train will consist of 50 Hz bursts, repeated at intervals of 200 ms (5 Hz) for 40 sec.
  • Sham TMS — DEVICE
    Subjects will receive a series of 100 single pulses to the right dlPFC at 100% of motor threshold. Pulses will be randomly jittered and have an average interpulse interval of 6 ± 4 seconds. Single pulses delivered in such a fashion have been shown to have little or no neuromodulatory effect on subsequent cortical excitability.

Study Details

The right dorsolateral prefrontal cortex (dlPFC) is increasingly being targeted with transcranial magnetic stimulation (TMS) to reduce anxiety expression; however, there is little mechanistic evidence supporting an optimized treatment protocol. Thus, the objective of the current project is to develop an interleaved TMS/fMRI that can assess the effect of neuromodulatory (potentially therapeutic) TMS protocols on neural and behavioral measures related to anxiety expression. PUBLIC HEALTH RELEVANCE: These results will yield direct evidence that 1 Hz and cTBS modulate brain activity associated with anxiety expression and regulation, thus informing novel TMS based anxiety treatments.

Key Dates

Start date
Jul 1, 2026
Status verified
Feb 2026
Primary completion
Jun 1, 2031
Completion
Jun 30, 2031

Study Design

Enrollment
140 participants (estimated)
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Transcranial Magnetic Stimulation
    A MagVenture MagPro 100X stimulator with a B91 figure-8 coil will be used for the TMS/fMRI rTMS sessions. Motor threshold testing will be done outside of the scanner using a separate MagVenture MagPro 100X with a separate B65 coil.

Primary Outcome Measure

TMS-evoked BOLD responses [ Time Frame: Subjects will undergo 4 study visits spaced over a 5-week period. On visits 3 (week 2) and 4 (week 5), TMS-evoked BOLD responses will be recorded immediately (within 5 minutes) before and after the intervention. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-6013
Nicholas Balderston, PhD
[email protected]
215-746-3058

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By research site
University of Pennsylvania· Philadelphia, PA

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