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ACTIVE NOT RECRUITING

NCT04064762

Targeted Plasticity Therapy for Posttraumatic Stress Disorder

Sponsor: Baylor Research Institute

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-12-16

Completion Date

2024-04

Last Updated

2023-01-05

Healthy Volunteers

Conditions

Post Traumatic Stress Disorder

Interventions

DEVICE

Paired Vagus Nerve Stimulation

Stimulation of the vagus nerve that is paired with Prolonged Exposure Therapy.

Inclusion Criteria * Patients diagnosed with chronic PTSD for at least 3 months based on the DSM-5 criteria (PSSI-5 score of 9-45) * Appropriate candidate for VNS implantation * Adult, aged 18-64 * Provision of signed and dated informed consent form * Willingness to comply with all study procedures and availability for the duration of the study * Right vocal cord has normal movement when assessed by laryngoscopy * Women of reproductive potential must use contraceptive protection Exclusion Criteria * PSSI-5 score of 46 or greater (very severe symptoms) * Current substance dependence * Currently undergoing prolonged exposure therapy elsewhere * Concomitant clinically significant brain injuries * Prior injury to vagus nerve * Prior or current treatment with vagus nerve stimulation * Participant receiving any therapy (medication or otherwise) that would interfere with VNS * Planning to become pregnant, currently pregnant, or lactating * Clinical complications that hinder or contraindicate the surgical procedure * Cognitive impairment that would interfere with study participation, confirmed by medical evaluation (will be assessed through chart review and with the Cognistat) * Psychological conditions such as schizophrenia, bipolar disorder, or psychosis that could interfere with study participation and follow-up * Participation in other interventional clinical trial * Participants with known immunodeficiency including participants who are receiving or have received chronic corticosteroids, immunosuppressants, immunostimulating agents or radiation therapy within 6 months * Significant comorbidities or conditions associated with high risk for surgical or anesthetic survival (e.g. renal failure, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.). * Active neoplastic disease. * Significant local circulatory problems that would interfere with device implantation and communication, (e.g. thrombophlebitis and lymphedema). * Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance. * Incarceration or legal detention * Non-English speaking * Patients who are acutely suicidal and/or have been admitted for a suicide attempt

Locations (1)

Baylor University Medical Center

Dallas, Texas, United States