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Recruiting NCT05560113

Disrupting Fear-based Memory Consolidation

No phase Interventional Post-Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continuous theta burst stimulation (cTBS), Sham continuous theta burst stimulation (cTBS).
Who it may be relevant to
Registry conditions: Post-Traumatic Stress Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Forgetting Fear: Establishing a Novel Non-invasive Approach to Disrupt Fear-based Sensory Memory Consolidation in Humans

Overview

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.

Detailed description

This mechanistic study in humans will study an unexplored precision-based approach of non-invasive neuromodulation of sensory cortex with the aim to prevent PTSD by attenuating the sensory encoding of fear memory. The objective of this project is to explore the basic science and therapeutic potential of sensory-emotional reprogramming in humans, and translate this idea into a precise, individualized treatment to reduce the risk that negative emotional sensory experiences lead to PTSD. Understanding sensory-emotional programming in humans could anchor a breakthrough 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 sequela of PTSD.

Interventions

  • Other 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
  • Other 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 measures

  • 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]
Secondary outcome measures (4)
  • Changes in Measures of skin conductive response [Time frame: Study Day 30 and Day 31]
  • ECG [Time frame: Study Day 31]
  • Acoustic Startle response [Time frame: Study Day 31]
  • Changes in Fear conditioning and extinction task [Time frame: Study Day 30 and Day 31]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Emory Rehabilitation Hospital — Atlanta
  • Emory University Hospital — Atlanta

Identifiers

NCT: NCT05560113 · STUDY00004510

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗