Disrupting Fear-based Memory Consolidation

Emory University

Status: Enrolling

Conditions: Post-Traumatic Stress Disorder

Treatments: Other: Sham continuous theta burst stimulation (cTBS); Other: Continuous theta burst stimulation (cTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05560113

STUDY00004510

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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.

Treatment:

Other: Continuous theta burst stimulation (cTBS)

Sham cTBS

Placebo Comparator group

Description:

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.

Treatment:

Other: Sham continuous theta burst stimulation (cTBS)