rTMS Pilot for Anxiety

NCT05306977 | Terminated Results FDA Device

• 1 other identifier: 850766
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• Anxiety Potentiated Startle (APS)

  Electromyography (EMG) startle responses were recorded from the left orbicularis oculi muscle using a Biopac MP160 unit (Biopac; Goleta, CA) via 15 × 20 mm electrodes (Rhythmlink #DECUS10026; Columbia, SC). EMG was bandpass filtered from 30 to 300 Hz, rectified, and smoothed using a 20-ms sliding window. Startle responses were scored as the peak (max during the 20 ms to 120 ms post-noise window) - the baseline (50 ms pre-noise window), and converted to t-scores with a mean of 50 and a standard deviation of 10 (tx = \[Zx × 10\] + 50). Greater t-scores mean larger blinks, which could be associated with greater anxiety, however there is no clinically relevent threshold. Noisy trials (baseline SD \> 2x run SD) were excluded, and "no blink" (peak \< baseline range) trials were coded as 0. To calculate APS within each timepoint, we subtracted the response during the neutral ITI from the response during the unpredictable ITI. T-scores represent the change from baseline to post stimulation.

  Post stimulation

• Visual Short Term Memory Performance (VSTM)

  Visual short term memory task: This task has been adapted from Vogel \& Machizawa (Vogel \& Machizawa, 2004). On each trial, subjects see an arrow (cue) pointing to the left or the right. After a short delay, they see a bilateral array of squares that vary in color, location, and angle of rotation (memory array). Subjects are instructed to encode the squares in the cued hemifield (targets) and ignore the squares contralateral to the cued hemifield (distractors). After another short delay (retention interval), subjects see a single square (response prompt) that is either an exact match (same color/location/angle) or a complete mismatch (different color/location/angle). Subjects are instructed to indicate whether the square is a match or a mismatch.

  Pre and post stimulation

Study Arms (1)

Pilot arm

OTHER

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.

Device: Open-label accelerated 1 Hz repetitive transcranial magnetic stimulation

Interventions

Open-label accelerated 1 Hz repetitive transcranial magnetic stimulation DEVICE

Patients will receive a 5-day course of accelerated 1 Hz rTMS (8x session x 600 pulses/session) to the right intraparietal sulcus. Subjects will receive a continuous train of 1 Hz stimulation. They will receive a total of 600 pulses per train. Trains will be separated by \~50 min rest intervals.

Pilot arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 32066739 BACKGROUND

Related Links

• Online Screening Form

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Nicholas Balderston
• Organization: University of Pennsylvania

nicholas.balderston@pennmedicine.upenn.edu

2157463058

Study Officials

• Nicholas L Balderston

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: May 19, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: April 21, 2023
• Results First Posted: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)