Open-label Pilot to Test a Novel 1 Hz Intensive Repetitive Transcranial Magnetic Stimulation Paradigm in Patients With Anxiety
Phase: NA
Conditions: Generalized Anxiety Disorder
Sponsor: University of Pennsylvania

  
Open-label pilot to test a novel 1 Hz intensive repetitive transcranial magnetic 
stimulation paradigm in patients with anxiety. 
 
Principal Investigator 
Nicholas Balderston 
 
NIH Grant Number                
IRB Number: 850766 
 
 
 
 
ClinicalTrials.gov Number  
 
 
 
NCT05306977 
 
 
Current version 
 
02/14/2022 V - 0.1 
Previous Versions  
 
 
 

Open-label 1 Hz rTMS pilot 
 
page 1 
02/14/2022 V - 0.1 
Study Summary 
Title 
Open-label pilot to test a novel 1 Hz intensive repetitive 
transcranial magnetic stimulation paradigm in patients with 
anxiety. 
 
Short Title 
Open-label 1 Hz rTMS pilot 
IRB Number 
 
Phase 
Pilot Study 
Methodology 
Open-label 
Study Duration 
1 years 
Study Center(s) 
Single-center 
Objectives 
Aim 1: Determine the effect of a 1-week course of intensive 1 
Hz stimulation on anxiety potentiated startle  
 
Aim 2: Determine the effect of a 1-week course of intensive 1 
Hz stimulation on attention control.   
Number of 
Subjects 
10 
Main Inclusion 
and Exclusion 
Criteria 
Anxiety patients, between 18 – 50 years old, free of 
psychological and neurological conditions, free of contra-
indications for TMS and MRI 
 

Statistical 
Methodology 
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.  
 
 
Data and Safety 
Monitoring Plan  
The Principal Investigator is responsible for detecting, 
documenting, and reporting unanticipated problems (UPs), 
adverse events (AEs), including serious adverse events (SAEs), 
and deviations in accordance with IRB requirements and federal 
regulations.