NCT06234969

Brief Summary

This study will be the first of its kind to explore the impact of continuous theta burst stimulation (cTBS) to the intraparietal sulcus (IPS) on arousal symptoms among patients with posttraumatic stress disorder (PTSD). The investigators will demonstrate that IPS cTBS results in significant reduction in arousal (measured by startle response) compared to sham cTBS, that IPS cTBS interacts with extinction training to further improve arousal, and that there is a dose/response effect of cTBS on arousal. The investigators will also demonstrate that IPS cTBS significantly improves retention of extinction learning, the experimental analogue of exposure therapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
30mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Apr 2024Oct 2028

First Submitted

Initial submission to the registry

January 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 29, 2024

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

4.3 years

First QC Date

January 22, 2024

Last Update Submit

October 28, 2025

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • Electromyography startle response

    Startle will be recorded from the left orbicularis oculi at 2000 Hz.

    Days 4, 5, 34 and 35

Secondary Outcomes (3)

  • Subjective Units of Distress (SUDS)

    Days 4, 5, 34 and 35

  • Negative outcome expectancy

    Days 4, 5, 34 and 35

  • fMRI

    Days 2, 5, and 35

Study Arms (2)

Continuous theta burst stimulation to the intraparietal sulcus

EXPERIMENTAL

Continuous theta burst stimulation will be delivered to the individually targeted intraparietal sulcus site at 100% RMT.

Device: Continuous Theta Burst Stimulation to the Intraparietal Sulcus

Sham continuous theta burst stimulation

PLACEBO COMPARATOR

We will use the coil's electric stimulation functionality that allows for the delivery of a brief electric pulse to the scalp simultaneous to the pulse to mimic actual stimulation.

Device: Sham Continuous Theta Burst Stimulation

Interventions

Continuous Theta Burst Stimulation to the Intraparietal SulcusDEVICE

Continuous Theta Burst Stimulation delivered to the Intraparietal Sulcus

Continuous theta burst stimulation to the intraparietal sulcus
Sham Continuous Theta Burst StimulationDEVICE

Sham Continuous Theta Burst Stimulation

Sham continuous theta burst stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult aged 18-60
  • Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for PTSD according to the Clinician-Administered PTSD Scale for DSM-5
  • No metal implants

You may not qualify if:

  • Pregnancy
  • Seizure disorder or epilepsy
  • Increased risk of seizure
  • Non-English speaking
  • Any medical condition that increases risk for fMRI or cTBS
  • Medical implant
  • Hearing loss sufficient to interfere with startle
  • Claustrophobia
  • Recent medication or therapy changes (in the past 8 weeks)
  • Current severe substance use disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for the Treatment and Study of Anxiety, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Lily A Brown, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lily A Brown, PhD

CONTACT

2157463346lilybr@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 31, 2024

Study Start

April 29, 2024

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

October 31, 2028

Last Updated

October 30, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

We will share data through the NIMH Data Archive using only de-identified data connected through the global unique identifier (GUID).

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be entered into the NIMH Data Archive every 6 months.
More information

Locations

US(1)