This study is testing a device called ReStore, which delivers Vagus Nerve Stimulation (VNS), for people with Post-Traumatic Stress Disorder (PTSD). VNS involves sending mild electrical pulses to a nerve in your neck. The study wants to see if combining VNS with Prolonged Exposure Therapy (PE) helps more than PE alone. You could be eligible if you are 22-79 years old, have chronic PTSD, and have not improved with at least one standard PTSD treatment. The main goal is to check the safety of the ReStore system. The current recruitment status is unclear, and the study plans to enroll 20 participants.

Study design

This is a randomized, controlled, and blinded study involving 20 participants. In the first phase, participants will be randomly assigned to receive either active VNS or a sham (inactive) VNS.

What's involved

Participants will have a device implanted and receive VNS alongside Prolonged Exposure Therapy twice weekly for 7 weeks in Phase 1, followed by additional PE sessions with active VNS in Phase 2. There will also be post-therapy assessments.

Compensation

Not stated in the trial record.

Follow-up

Safety will be assessed for up to 2 years following implantation or until the device is FDA approved, whichever comes first. Post-therapy assessments will also be performed 1 day, 1 month, and 6 months after the final therapy session.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.