Transcranial Magnetic Stimulation for Anxiety

Overseen By Nicholas Balderston, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: CNS medications

Disqualifiers: Neurological problems, Psychiatric comorbidity, Alcohol/drug problems, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Nicholas Balderston, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

Inclusion Criteria

Able to give their consent

I have been on the same anxiety medication for at least 4 weeks.

Right-handed

Exclusion Criteria

Non-english speaking

I do not have any serious medical or neurological conditions.

I have a higher risk of having seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo baseline assessments including anxious arousal, resting state functional connectivity, and TMS-evoked BOLD responses

1 week

1 visit (in-person)

Treatment

Participants receive 600 pulses of cTBS or sham stimulation with TMS-evoked BOLD responses recorded before and after the intervention

5 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including anxiety potentiated startle and TMS-evoked BOLD responses

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active TMS
• Sham TMS

How Is the Trial Designed?

Group I: Transcranial Magnetic Stimulation Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+