Plain-English translation of NCT06266364 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This study is testing a treatment that combines two approaches: talk therapy (called prolonged exposure therapy) and vagus nerve stimulation (VNS) delivered through a surgically implanted device called the ReStore Device. The vagus nerve is a major nerve in your body, and gentle electrical stimulation of it may help your brain process trauma and reduce PTSD symptoms more effectively when paired with therapy.
Standard PTSD treatments work well for many people, but some individuals continue to struggle with severe symptoms even after trying proven therapies. This trial is exploring whether adding the device's stimulation to therapy can help people whose PTSD hasn't improved with traditional approaches alone.
You likely qualify if…
You likely don't qualify if…
If you qualify, you'll have surgery to implant the device, then participate in two phases over several months. In Phase 1 (7 weeks), you'll attend therapy twice weekly and receive either real or sham stimulation—neither you nor your therapist will know which until Phase 1 ends. In Phase 2, everyone receives active stimulation paired with additional therapy sessions. Between office visits, you'll use a secure app on a smart device that triggers stimulation during homework assignments. You'll have check-in assessments at 1 day, 1 month, and 6 months after therapy ends, plus safety monitoring visits over the following 2 years.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
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