Disrupting Fear-based Memory Consolidation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (4)

• Changes in Measures of skin conductive response [Срок оценки: Study Day 30 and Day 31]
• ECG [Срок оценки: Study Day 31]
• Acoustic Startle response [Срок оценки: Study Day 31]
• Changes in Fear conditioning and extinction task [Срок оценки: Study Day 30 and Day 31]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Emory Rehabilitation Hospital — Atlanta
• Emory University Hospital — Atlanta

Идентификаторы

NCT: NCT05560113 · STUDY00004510

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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