Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT05560113

Conditions

Post-Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Continuous theta burst stimulation (cTBS)

Sham continuous theta burst stimulation (cTBS)

Study Details

Brief summary:

This project represents a unique collaborative opportunity to pursue the essential proof-of-principle demonstration that non-invasive interference of sensory cortical memory consolidation shortly after an emotional experience can attenuate the cued fear response and potentially reduce the risk of developing post-traumatic stress disorder (PTSD). If successful, the study results would anchor a potential advance in the treatment of patients after a traumatic event and seed future animal and clinical studies of emotional sensory cortical memory consolidation to reduce the prevalence and negative sequelae of PTSD.

Conditions

Post-Traumatic Stress Disorder

Study ID

NCT05560113

Start date

Nov 28, 2022

Status verified date

Oct, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ability to provide informed consent
  • Willingness to participate in study
  • No history of musculoskeletal impairment or neurological disease
  • Clinical diagnosis of PTSD for individuals in the PTSD group.

Exclusion Criteria:

  • Any participant outside the age range
  • Participants that show signs of dementia (score < 20 on the Montreal Cognitive Assessment)
  • Participants that have a history of major head trauma, a neurodegenerative disorder, or recent (<6 months) substance abuse;
  • Participants that had a recent history of Central Nervous System (CNS) active drugs that may influence cortical excitability or learning; or
  • Participants that report contraindications to TMS or MRI - if participating in the TMS/MRI experiments
  • Current psychoactive medication usage
  • Current symptoms of psychosis or bipolar disorder (as indicated by study staff through a clinical interview as part of that study).
  • The study will exclude adults unable to consent, individuals who are not yet adults, pregnant women and prisoners on scientific grounds and to minimize risk.

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: cTBS: Inhibitory Transcranial magnetic stimulation (TMS) to sensory Cortex

Participants will undergo a Functional magnetic resonance imaging (fMRI) scan while performing a fear conditioning/extinction task at the Center for Systems Imaging- Emory University Hospital (CSI-EUH) and then either stay at CSI-EUH or relocate to the Neural Plasticity Research Laboratory at Emory Rehabilitation Hospital. Participants will then be randomly assigned to either receive active or sham continuous theta burst stimulation (cTBS) to transiently disrupt neural activity in the targeted sensory cortex region specifically during the sensory memory consolidation window.

placebo comparator: Sham cTBS

Participants will undergo a Functional magnetic resonance imaging (fMRI) scan while performing a fear conditioning/extinction task at CSI-EUH and then either stay at CSI-EUH or relocate to the Neural Plasticity Research Laboratory at Emory Rehabilitation Hospital. Participants will then be randomly assigned to either receive active or sham continuous theta burst stimulation (cTBS) to transiently disrupt neural activity in the targeted sensory cortex region specifically during the sensory memory consolidation window.

Interventions

Continuous theta burst stimulation (cTBS)

cTBS, a patterned form of TMS, (80% active motor threshold intensity, 3 pulses at 50Hz, 200ms interval, 600 pulses, 40s duration applied over the targeted sensory cortical region using real-time neuronavigation to focally and transiently inhibit neural activity

Sham continuous theta burst stimulation (cTBS)

This will be a sham intervention. An active/sham stimulating coil will be used for double-blinding of stimulation condition. cTBS is safe and has established safety guidelines that will be strictly adhered to during study conduction.

Primary outcome measure

  • Changes in Neural Connections: Functional network connectivity [ Time Frame: Study Day 30 and Day 31 ]
  • Changes in Neural Connections: Regional activation [ Time Frame: Study Day 30 and 31 ]

Central Contacts and Locations

Central contacts

Michael Borich, PhD

404-712-5512michael.borich@emory.edu

Jennifer Stevens, PhD

404-778-1698jswils4@emory.edu

Locations

Emory Rehabilitation Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Michael Borich, PhD

404-712-0612michael.borich@emory.edu

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Michael Borich, PhD

404-712-0612michael.borich@emory.edu

Robert C Liu, PhD

404-727-5274robert.liu@emory.edu

More Information

Sponsor

Emory University

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • Fear
  • Transcranial Magnetic Stimulation
  • Memory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-10-29.