Prism is a software device intended for neurofeedback (NF) training (i.e. operant condition based on EEG signals, also known as EEG-biofeedback), to be used in combination with a standard computer and supported EEG hardware. For purposes of this training, information for feedback is derived and processed from several EEG channels. Prism provides visual and/or auditory signals that correspond to the patient's computed EEG signal, which serves as a surrogate indicator of achieving a state of reduced amygdala activity.~The study is 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).~The study population will include subjects diagnosed with Post-Traumatic Stress Disorder (PTSD) from 1 year to 20 years after index trauma. The total expected enrollment is up to 100 subjects in one or more sites.~The study's primary objective is to assess the safety and effectiveness of fifteen (15) EEG-NF training sessions using the Prism software in reducing PTSD-related symptoms.
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)