PTSD, Post Traumatic Stress DisorderNCT06266364
Targeted Plasticity Therapy for PTSD
A study testing Active VNS stimulation in people with PTSD, Post Traumatic Stress Disorder, run by The University of Texas at Dallas at 3 sites in United States.
Trial summary
Objectives of this study are to provide continued safety assessment for the ReStore system, and to gain further estimates of the effect size of Vagus Nerve Stimulation (VNS) therapy with Prolonged Exposure Therapy (PE) compared to PE with placebo (sham) stimulation in participants with posttraumatic stress disorder… Read more about this study
- Who is it for?
- Ages 22 to 79 years
- Conditions the study is for
- PTSD, Post Traumatic Stress Disorder
- What is being tested?
- Active VNS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Dec 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic PTSD for at least 3 months based on DSM-5 criteria
- 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
- PCL-5 score greater than 33
- Age 22-79 years
- Appropriate surgical candidate for VNS device implantation
- Willing and able to comply with study protocol
- Able to provide informed consent.
Who cannot join
- Currently undergoing prolonged exposure therapy elsewhere
- Concurrent participation in another interventional clinical trial
- Prior injury to vagus nerve
- Prior or current treatment with vagus nerve stimulation
- Psychiatric disorders and/or cognitive impairments that would interfere with study participation, as assessed by medical evaluation
- Moderate-High Risk of Suicide according to Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version
Show all 14Show fewer
- 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
- Persons with a neck circumference larger than 18.5 inches
- 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
- Non-English speaking
- As determined by the principal investigator, is under current incarceration or legal detention
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The University of Texas Health Austin Ambulatory Surgery Center
Austin, Texas, 78712
- Recruiting
Baylor University Medical Center
Dallas, Texas, 75246
214-820-9420
- Recruiting
Texas Biomedical Device Center
Richardson, Texas, 75080
Amy Porter, 972-883-7256
About this study
Official title: Targeted Plasticity Therapy for the Treatment of Post-Traumatic Stress Disorder
Objectives of this study are to provide continued safety assessment for the ReStore system, and to gain further estimates of the effect size of Vagus Nerve Stimulation (VNS) therapy with Prolonged Exposure Therapy (PE) compared to PE with placebo (sham) stimulation in participants with posttraumatic stress disorder (PTSD)
Read the detailed description
A prospective, multi-center, randomized, controlled, blinded trial of participants implanted with the ReStore Device for VNS Therapy.
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
- PTSD, Post Traumatic Stress Disorder
- Being tested
- Active VNS stimulation, Sham VNS stimulation
- Keywords
- PTSD, Post-Traumatic Stress Disorder, VNS, Vagus Nerve Stimulation, TPT, Targeted Plasticity Therapy, ReStore System, PE, Prolonged Exposure Therapy, Trauma and Stressor Related Disorders, Mental Disorders, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic
- Medical subject headings
- Combat Disorders, Trauma and Stressor Related Disorders, Mental Disorders, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active VNS stimulationDevice
The subjects in this group will be implanted with the ReStore device and receive active Vagus nerve stimulation (VNS) in phase 1
Sham VNS stimulationDevice
The subjects in this group will be implanted with the ReStore device and receive sham Vagus nerve stimulation (VNS) in phase 1
| Study group | Role | What they receive |
|---|---|---|
| Immediate VNS Group | Active comparator | 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. Receives: Device: Active VNS stimulation |
| Delayed VNS Group | Sham comparator | 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. Receives: Device: Sham VNS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ReStore System Safety
ReStore System safety by review of any adverse events
Measured: From surgery to up to 2 years following implantation or until the device is FDA approved, whichever comes first
Secondary outcomes (5)
Clinician Administered PTSD Scale for DSM-5(fifth edition of the Diagnostic and Statistical Manual of Mental Disorders)(CAPS-5)
The CAPS-5 is a 30-item structured PTSD diagnostic interview that measures PTSD. Total scores range from 0-80, with higher scores indicating more severe PTSD symptoms symptoms.
Measured: From baseline up to visit 33 (end of study)
PTSD Checklist for DSM-5 (PCL-5) score
The PCL-5 is a 20 item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Total scores range from 0-80, with higher scores indicating more severe PTSD symptoms symptoms.
Measured: From baseline up to visit 33 (end of study)
PostTraumatic Cognitions Inventory (PTCI)
The PTCI is a 33-item instrument that assesses dysfunctional post-trauma cognitions across self, world, and self-blame to yield a total score. Total scores range from 33-231, with higher scores reflecting greater endorsement of negative posttraumatic cognitions.
Measured: From baseline up to visit 33 (end of study)
Generalized Anxiety Disorder 7-item Scale (GAD-7)
The GAD-7 is a 7-item questionnaire that measures severity of anxiety. Total scores range from 0-21, with higher scores reflecting severe anxiety symptom levels.
Measured: From baseline up to visit 33 (end of study)
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a brief self-report measure of major depressive disorder. Total scores range from 0-27, with higher scores reflecting severe depression symptom levels.
Measured: From baseline up to visit 33 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start30 Dec 2024
- Primary completionSep 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD, Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization of active stimulation vs. sham stimulation for 12 sessions post randomization, followed by up to 12 sessions of open label active stimulation for all participants
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs, The University of Texas Health Science Center at San Antonio
- Responsible party
- Principal investigator, Dr. Seth Hays, The University of Texas at Dallas
- Investigators
- Jane Wigginton, MD, Principal investigator, The University of Texas at DallasRobert Rennaker, PhD, Principal investigator, The University of Texas at DallasJasper Smits, PhD, Principal investigator, The University of Texas at AustinMichael Foreman, MD, Principal investigator, Baylor Scott and White HealthMichael Kilgard, PhD, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266364
- Sponsor's protocol ID
- IRB-24-22
- Other IDs
- HT94252310818, 175181
- Status last verified
- Jun 2026
- First submitted
- 8 Feb 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Plasticity Therapy for the Treatment of Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06266364
- Acronym / sponsor ID
- IRB-24-22
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Keywords
- PTSD, Post-Traumatic Stress Disorder, VNS, Vagus Nerve Stimulation, TPT, Targeted Plasticity Therapy, ReStore System, PE, Prolonged Exposure Therapy, Trauma and Stressor Related Disorders, Mental Disorders, Stress Disorders, Traumatic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs, The University of Texas Health Science Center at San Antonio
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives of this study are to provide continued safety assessment for the ReStore system, and to gain further estimates of the effect size of Vagus Nerve Stimulation (VNS) therapy with Prolonged Exposure Therapy (PE) compared to PE with placebo (sham) stimulation in participants with posttraumatic stress disorder (PTSD)
Detailed description
A prospective, multi-center, randomized, controlled, blinded trial of participants implanted with the ReStore Device for VNS Therapy.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization of active stimulation vs. sham stimulation for 12 sessions post randomization, followed by up to 12 sessions of open label active stimulation for all participants
| Arm | Type | Receives |
|---|---|---|
| Immediate VNS Group | Active comparator | Device: Active VNS stimulationThe 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. |
| Delayed VNS Group | Sham comparator | Device: Sham VNS stimulationThe 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. |
Who may qualify
- Ages
- 22 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of chronic PTSD for at least 3 months based on DSM-5 criteria
- 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
- PCL-5 score greater than 33
- Age 22-79 years
- Appropriate surgical candidate for VNS device implantation
Key exclusion criteria (14 listed)
- Currently undergoing prolonged exposure therapy elsewhere
- Concurrent participation in another interventional clinical trial
- Prior injury to vagus nerve
- Prior or current treatment with vagus nerve stimulation
- Psychiatric disorders and/or cognitive impairments that would interfere with study participation, as assessed by medical evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active VNS stimulationThe subjects in this group will be implanted with the ReStore device and receive active Vagus nerve stimulation (VNS) in phase 1 | Device | Immediate VNS Group |
| Sham VNS stimulationThe subjects in this group will be implanted with the ReStore device and receive sham Vagus nerve stimulation (VNS) in phase 1 | Device | Delayed VNS Group |
Primary outcome
ReStore System Safety
Time frame: From surgery to up to 2 years following implantation or until the device is FDA approved, whichever comes first
ReStore System safety by review of any adverse events
5 secondary outcomes
Clinician Administered PTSD Scale for DSM-5(fifth edition of the Diagnostic and Statistical Manual of Mental Disorders)(CAPS-5)
Time frame: From baseline up to visit 33 (end of study)
PTSD Checklist for DSM-5 (PCL-5) score
Time frame: From baseline up to visit 33 (end of study)
PostTraumatic Cognitions Inventory (PTCI)
Time frame: From baseline up to visit 33 (end of study)
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: From baseline up to visit 33 (end of study)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: From baseline up to visit 33 (end of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jane Wigginton, MD principal investigator
The University of Texas at Dallas
Robert Rennaker, PhD principal investigator
The University of Texas at Dallas
Jasper Smits, PhD principal investigator
The University of Texas at Austin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active VNS stimulation in people with PTSD, Post Traumatic Stress Disorder, run by The University of Texas at Dallas at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Porter (972-883-7256, alp160730@utdallas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ReStore System Safety (time frame: From surgery to up to 2 years following implantation or until the device is FDA approved, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.