Targeted Plasticity Therapy for Posttraumatic Stress Disorder

Baylor Scott and White Health (BSWH)

Status

Active, not recruiting

Conditions

Post Traumatic Stress Disorder

Treatments

Device: Paired Vagus Nerve Stimulation

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT04064762

N66001-15-2-4057 (Other Grant/Funding Number)

019-280

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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