Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-12-30
2028-06-30
Brief Summary
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Detailed Description
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In double-blinded Phase 1, after implantation, participants will be randomized to either active VNS stimulation or sham VNS stimulation, accompanying PE therapy twice weekly for 7 weeks (12 in-office sessions, Phase 1). The therapist and the participant will be blinded of the group assignment.
Following completion of Phase 1, all participants undergo two mid-therapy assessments and then advance to the open-label Phase 2.
In open-label Phase 2, all participants will receive up to an additional 12 sessions of PE therapy paired with active VNS stimulation, regardless of their prior assignment in Phase 1.
Post-therapy assessments will be performed 1 day, 1 month, and 6 months following the completion of the final session of PE in Phase 2.
During the in-office sessions, the therapist will use a secure smart device to deliver stimulation and record audio of the session for use during homework sessions. The smart device will automatically trigger VNS during audio homework sessions at the same times that the therapist delivered VNS during the corresponding in-office session.
Long-term assessment of safety will be performed up to four times annually for up to 2 years following the date of implant or until the device is FDA approved when possible. Safety assessment will only report on the presence of the implanted, non-active device and/or participant status during this period. Participants who experience a serious device-related adverse event will be removed from the identified risk but will continue to be monitored for 2 years or longer if the event has not resolved.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Immediate VNS Group
The participants in this arm will be implanted with the device and will receive active VNS stimulations in phase 1 as well as phase 2 of the study.
Active VNS stimulation
The subjects in this group will be implanted with the ReStore device and receive active Vagus nerve stimulation (VNS) in phase 1
Delayed VNS Group
The participants in this arm will be implanted with the device but will receive sham VNS stimulations in phase 1 of the study and active VNS in phase 2 of the study.
Sham VNS stimulation
The subjects in this group will be implanted with the ReStore device and receive sham Vagus nerve stimulation (VNS) in phase 1
Interventions
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Active VNS stimulation
The subjects in this group will be implanted with the ReStore device and receive active Vagus nerve stimulation (VNS) in phase 1
Sham VNS stimulation
The subjects in this group will be implanted with the ReStore device and receive sham Vagus nerve stimulation (VNS) in phase 1
Eligibility Criteria
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Inclusion Criteria
2. In the medical opinion of the Principal Investigator (PI), failed at least one adequate course of first-line PTSD treatment per American Psychological Association (APA) guidelines
3. PCL-5 score greater than 33
4. Age 22-79 years
5. Appropriate surgical candidate for VNS device implantation
6. Willing and able to comply with study protocol
7. Able to provide informed consent.
Exclusion Criteria
2. Concurrent participation in another interventional clinical trial
3. Prior injury to vagus nerve
4. Prior or current treatment with vagus nerve stimulation
5. Psychiatric disorders and/or cognitive impairments that would interfere with study participation, as assessed by medical evaluation
6. Moderate-High Risk of Suicide according to Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version
7. Persons with a current or past: (a) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability or (b) non-medical situation or circumstance that, in the opinion of the principal investigator, study participation:
* may pose a significant or undue risk to the person,
* make it unlikely the person will complete all the study requirements per protocol, or
* may adversely impact the integrity of the data or the validity of the study results
8. Persons with a neck circumference larger than 18.5 inches
9. Females of childbearing potential who are either pregnant or planning to become pregnant and who are not using, or will not agree to use medically acceptable birth control methods
10. Non-English speaking
11. As determined by the principal investigator, is under current incarceration or legal detention
22 Years
79 Years
ALL
No
Sponsors
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Congressionally Directed Medical Research Programs
FED
The University of Texas Health Science Center at San Antonio
OTHER
The University of Texas at Dallas
OTHER
Responsible Party
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Dr. Seth Hays
Professor
Principal Investigators
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Jane Wigginton, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas at Dallas
Robert Rennaker, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas at Dallas
Jasper Smits, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas at Austin
Mark Powers, PhD
Role: PRINCIPAL_INVESTIGATOR
Baylor Scott & White
Michael Kilgard, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas at Dallas
Locations
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The University of Texas Health Austin Ambulatory Surgery Center
Austin, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Texas Biomedical Device Center
Richardson, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Amy Porter
Role: primary
Other Identifiers
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HT94252310818
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
175181
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-24-22
Identifier Type: -
Identifier Source: org_study_id
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