A Prospective Single Arm Open Label Pilot Trial to Assess Safety and Effectiveness of PRocess-Instructed Self neuro-Modulation ("Prism") as an Adjunct to Standard of Care in Subjects with Post-Traumatic Stress Disorder (PTSD)

Brief description of study

The main purpose of this study is to assess the safety and effectiveness of PRISM, a software device intended for neurofeedback (NF) training, when added onto standard of care treatment in people with PTSD. Neurofeedback is a type of biofeedback that uses real-time displays of brain activity to attempt to teach self-regulation of brain function. EEG electrodes (called sensors) are placed on the scalp to measure brain activity and the measurements are displayed on a video to guide self-regulation. The study will enroll up to 100 subjects across all sites, with up to 20 enrolled at NYULH. The study will last about 22 weeks from screening to the last follow up assessment visit. Some visits may be conducted remotely over the phone ore secure video conferencing platform.

Clinical Study Identifier: s21-00415
ClinicalTrials.gov Identifier: NCT04891614

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