Disrupting Fear-based Memory Consolidation

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05560113
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Continuous theta burst stimulation (cTBS) — OTHER
    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) — OTHER
    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.

Study Details

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.

Key Dates

Start date
Nov 28, 2022
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory Rehabilitation HospitalAtlantaGeorgia30322
Michael Borich, PhD
[email protected]
404-712-0612
Emory University HospitalAtlantaGeorgia30322
Michael Borich, PhD
[email protected]
404-712-0612
Robert C Liu, PhD
[email protected]
404-727-5274

Find similar trials in Atlanta, GA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Emory Rehabilitation Hospital· Atlanta, GAEmory University Hospital· Atlanta, GA

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