Vagus Nerve Stimulation for Post-Traumatic Stress Disorder
Trial Summary
What is the purpose of this trial?
Posttraumatic stress disorder is a debilitating condition that develops in the aftermath of a traumatic experience, leading to hyperarousal, heightened anxiety, and uncontrolled fear that can be driven by intrusive memories or trauma reminders. The Texas Biomedical Device Center has developed a novel technique, termed targeted plasticity therapy (TPT), to boost neuroplasticity in conjunction with various forms of rehabilitation, including prolonged exposure therapy. The technique involves stimulation of the vagus nerve. The purpose of this open-label pilot study is to assess the safety of using a new device to deliver vagus nerve stimulation to reduce symptom severity in participants with PTSD when paired with prolonged exposure therapy. Additionally, the study will assess the prospective benefit of the system and garner an initial estimate of efficacy for a subsequent trial.
Eligibility Criteria
Adults aged 18-64 with chronic PTSD for at least 3 months, who can give informed consent and follow study procedures. They must have normal vocal cord movement, use contraception if of reproductive potential, and be suitable for VNS implantation. Excluded are those on interfering therapies, pregnant or lactating women, individuals with significant health risks or conditions affecting the study's integrity, non-English speakers, prior vagus nerve injury cases, very severe PTSD sufferers (PSSI-5 score >45), and those with certain psychological conditions.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Paired Vagus Nerve Stimulation (Vagus Nerve Stimulation)