What this study is
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.
What's being tested
- Active TMS
Intervention · 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
Intervention · 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
- Official title
- The Effect of Right dlPFC cTBS on Acute Measures of Anxiety, Functional Connectivity, and TMS-evoked BOLD Responses.
- Sponsor
- University of Pennsylvania
- Conditions
- Anxiety
- Enrolling
- 140 people
- Starts
- 2026-11-01
- Est. completion
- 2031-06-30
- Design
- Open-label, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 50 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Able to give their consent
- Right-handed
- Individuals receiving therapy for anxiety must be stable on their regimen for at least 4 weeks prior to study enrollment.
You can't join if
- Non-english speaking
- Any significant medical or neurological problems
- Current or past non-anxiety-related psychiatric comorbidity, active or history of active suicidal ideation
- Alcohol/drug problems in the past year or lifetime alcohol or drug dependence
- Medications that act on the central nervous system
- History of seizure
- History of epilepsy
- Increased risk of seizure for any reason
- Pregnancy, or positive pregnancy test
- Any medical condition that increases risk for fMRI or TMS
- Any metal in their body which would make having an MRI scan unsafe
- Any sort of medical implants
- Hearing loss
- Claustrophobia
- Orthostatic hypotension
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
- Nicholas Balderston, PhD · Contact215-746-3058nicholas.balderston@pennmedicine.upenn.edu
Study team
Sponsor
University of Pennsylvania
Study ID 860105
Principal investigator
Nicholas Balderston, PhD
University of Pennsylvania
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.