This supportive care trial (n=200) will investigate the sustained remission from posttraumatic stress disorder (PTSD) using Tuned Vibroacoustic Stimulation (TVS) following MDMA-assisted psychotherapy.
The study, sponsored by Apollo Neuroscience, Inc., aims to assess the effect of the Apollo wearable device on individuals who have undergone MDMA-assisted psychotherapy for PTSD.
Participants will receive the Apollo wearable device, which emits gentle vibrations, and will be instructed to use it regularly for two years following their psychotherapy sessions. The primary objective is to determine if the regular use of the Apollo device improves rates of sustained symptom remission in PTSD following MDMA-assisted psychotherapy. The study will involve completing monthly online questionnaires to monitor outcomes related to PTSD symptoms, depression, anxiety, emotion regulation, work performance, alcohol and drug use, and chronic pain.
Participants aged 18 and older who have completed the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial are eligible to participate. The study commenced on December 8, 2021, and is estimated to be completed by December 31, 2025.
Trial Details
The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects outcomes related to MDMA-assisted psychotherapy for PTSD including depression, anxiety and emotion regulation. This study will test whether regular use of the Apollo wearable improves rates of sustained symptom remission in PTSD following MDMA-assisted psychotherapy over the course of two years.NCT Number NCT05274230
Sponsors & Collaborators
Apollo NeuroApollo Neuroscience is a company focused on developing wearable technology that actively enhances health by using touch therapy.