Clinical trial NCT05560113: Disrupting Fear-based Memory Consolidation
Official title: Forgetting Fear: Establishing a Novel Non-invasive Approach to Disrupt Fear-based Sensory Memory Consolidation in Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: Fear
Transcranial Magnetic Stimulation
Memory
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Changes in Neural Connections: Functional network connectivity
timeFrame: Study Day 30 and Day 31
measure: Changes in Neural Connections: Regional activation
timeFrame: Study Day 30 and 31
Secondary outcomes:
measure: Changes in Measures of skin conductive response
timeFrame: Study Day 30 and Day 31
measure: ECG
timeFrame: Study Day 31
measure: Acoustic Startle response
timeFrame: Study Day 31
measure: Changes in Fear conditioning and extinction task
timeFrame: Study Day 30 and Day 31
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Rehabilitation Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Michael Borich, PhD
role: PRINCIPAL_INVESTIGATOR
References: