Clinical trial announced to assess effectiveness of wearable PTSD treatment

Apollo Neuroscience has announced the start of a clinical trial to provide insight into how its proprietary wearable touch therapy device impacts long-term outcomes following MDMA-assisted therapy in people with PTSD.

The trial will be conducted with the support of the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit sponsoring clinical trials for psychedelic-assisted therapy, according to a release issued by Apollo.

Apollo seeks to improve sleep, relaxation, focus and recovery by toning the nervous system, providing the wearer more control over their mental state as well as overall health, per the release.

Worn on either the wrist, ankle, or clipped to clothing on any other part of the body, the device works by engaging with the wearer’s sense of touch, delivering silent, soothing vibrations that aim to provide a sense of safety and control.

Apollo’s technology attempts to train an individual’s nervous system to bounce back from stress more quickly, making it easier to progress from a fight or flight response to rest and digest mode, the company said.

“We’ve seen tremendous results with the Apollo wearable in thousands of traumatized individuals and those who have participated in psychedelic-assisted therapy thus far,” Dave Rabin, MD, PhD, co-founder/CIO of Apollo, said in the release. “We are very much looking forward to seeing how the Apollo wearable will contribute to the integration period following MDMA-assisted therapy.”

Preliminary data from ongoing clinical trials of the Apollo technology show the device has been found to improve sleep while reducing feelings of anxiety, low mood and irritability.

Per the release, two more large clinical trials evaluating the Apollo wearable in patients with PTSD are under way and recruiting participants. The first study has begun at the Rocky Mountain VA in Denver, and the second is a nationwide trial open to anyone who has participated in a MAPS trial of MDMA-assisted therapy.

“Maximizing patient outcomes means exploring options for people to continue the healing and integration process after the course of MDMA-assisted therapy is complete,” Rick Doblin, founder and executive director of MAPS, said in the release. “We’re pleased to support the option for MDMA-assisted therapy study participants to try the Apollo wearable once the long-term follow up has been completed.”