Viewing Study NCT03858933


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Study NCT ID: NCT03858933
Status: TERMINATED
Last Update Posted: 2021-08-27
First Post: 2018-11-16
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Train Your Brain: Neurofeedback Intervention for PTSD
Sponsor: University of Southern California
Organization:

Study Overview

Official Title: Train Your Brain: A Neurofeedback Intervention for Individuals With Post-Traumatic Stress Disorder
Status: TERMINATED
Status Verified Date: 2021-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: COVID-19 Regulations
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The investigator's aim is to evaluate the efficacy of two types of neurofeedback treatments for PTSD symptoms reduction. Half of the participants will receive the current standard for PTSD neurofeedback care undergoing alpha/theta neurofeedback regulation. The other half will receive the newly developed limbic modulation index neurofeedback.
Detailed Description: Traumatic stress is commonly resistant to existing therapeutics, possibly due to high treatment dropout rates along with a failure to target the relevant underlying neural mechanisms. Neuromodulation of deep limbic areas such as the amygdala may play a critical role in the effective recovery from traumatic stress. Human studies have shown the importance of such modulation during the encoding of traumatic stimuli, showing greater amygdala activation for subsequently remembered traumatic stimuli. In addition, a prospective study among previously healthy soldiers showed that hyper-activation of the amygdala prior to military traumatic exposure corresponded with more severe post-traumatic symptoms following exposure.

Together these finding points to the amygdala as a plausible neuromodulation target for preventive or early interventions of post-traumatic disturbances. Local neuromodulation of the amygdala could improve treatment specificity and the overall intervention outcome.

The main goal of the suggested research is to further develop and implement a non-invasive, portable and cost-effective brain-imaging tool that will provide individual on-line guidance for amygdala modulation. This closed-loop brain training will enhance individual resilience to and coping with potentially traumatic stress as well as alleviate consequential psychopathologies.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: