Clinical trial NCT05306977: rTMS Pilot for Anxiety
Official title: Open-label Pilot to Test a Novel 1 Hz Intensive Repetitive Transcranial Magnetic Stimulation Paradigm in Patients With Anxiety
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Aim 1: Outcome measures. Anxiety potentiated startle (APS) Statistical Analysis. The main analysis will be a paired-sample t-test (pre vs. post stimulation).

Aim 2: Outcome measures. Accuracy and reaction time during the visual short term memory task (VSTM). Statistical Analysis. The main analysis will be a 2 \[stimulation: pre-stimulation vs. post-stimulation\] by 2 \[load: low vs. high\] repeated-measures ANOVA. Safety and Adverse Events
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety and tolerability of 1 Hz parietal stimulation in anxiety. Our approach will be to administer 1 week of open-label accelerated 1 Hz parietal rTMS (5 days, 8 sessions/day, 600 pulses/session) and measure the effect of this neuromodulation on APS, and short term memory in a cohort of anxiety GAD patients.

Detailed description: Aims 1 and 2 of this project will be tested using a within-subjects design where anxiety patients will receive a 5-day course of accelerated 1 Hz rTMS (8x session x 600 pulses/session) to the right IPS. In Aim 1, we will test the effects of this stimulation on arousal during the NPU threat task (NPU section). In Aim 2 below, we will test the effects of this stimulation on arousal-related attention control deficits using the VSTM task (VSTM section).

Subjects will undergo 7 study visits spaced over a roughly 3-week period depending upon availability. First, subjects will have a pre-stimulation test visit. On this visit they will undergo the following procedures: 1) motor threshold testing, 2) noise habituation, 3) shock workup 4) NPU task, 5) VSTM task. Then they will have 5 rTMS visits. On these visits, subjects will receive 8 trains of 1 Hz rTMS (600 pulses per train, each separated by \~50 min). Finally, they will have a post-stimulation test visit, which will included the noise habituation, shock workup, NPU task, and VSTM task.

Eligibility criteria: Inclusion Criteria

* Meet the DSM-V criteria for an anxiety disorder (i.e. generalized anxiety disorder, social anxiety disorder, panic disorder, etc.)
* Subjects must be 18-50 years old
* Able to give their consent
* Right-handed

Exclusion Criteria

* Non-english speaking
* Any significant medical or neurological problems
* Current or past (non-anxiety) Axis I psychiatric disorder(s), active or history of active suicidal ideation
* Alcohol/drug problems in the past year or lifetime alcohol or drug dependence
* Any medical condition that increases risk for TMS
* History of seizure
* History of epilepsy
* Increased risk of seizure for any reason
* Pregnancy, or positive pregnancy test
* Hearing loss

Primary outcomes:
measure: Anxiety Potentiated Startle (APS)
timeFrame: Post stimulation
measure: Visual Short Term Memory Performance (VSTM)
timeFrame: Pre and post stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Nicholas L Balderston
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balderston NL, Beydler EM, Goodwin M, Deng ZD, Radman T, Luber B, Lisanby SH, Ernst M, Grillon C. Low-frequency parietal repetitive transcranial magnetic stimulation reduces fear and anxiety. Transl Psychiatry. 2020 Feb 17;10(1):68. doi: 10.1038/s41398-020-0751-8.