Stress Disorders, Post-TraumaticNCT07886840
Salience Network Informed rTMS for PTSD
A study testing Active MRI-Guided intermittent theta burst stimulation (iTBS) in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The proposed study will test whether magnetic resonance imaging (MRI)-guided transcranial magnetic stimulation (TMS) can reduce posttraumatic stress disorder (PTSD) symptoms in Veterans. TMS is a noninvasive treatment that uses magnetic pulses to change activity in specific areas of the brain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Active MRI-Guided intermittent theta burst stimulation (iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 31 Mar 2031
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Veteran status
- Current diagnosis of posttraumatic stress disorder (PTSD), as determined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
- Able to provide informed consent
- Able to speak, read, and write English
- Willing and able to complete 20 intermittent theta burst stimulation (iTBS) treatment sessions, scheduled 5 days per week for 4 weeks, with completion permitted within up to 6 weeks when needed
- Willing and able to complete magnetic resonance imaging (MRI) assessments before and after the iTBS treatment course
Who cannot join
- History of a neurological disorder associated with cognitive dysfunction, such as dementia or mild cognitive impairment
- History of traumatic brain injury associated with an estimated loss of consciousness greater than 30 minutes
- Current acute suicidal ideation or recent psychiatric hospitalization when, in the judgment of the study clinician or treating psychiatrist, the condition would interfere with safe study participation
- Current psychotic disorder or bipolar disorder/mania
- Current severe alcohol or substance use disorder; Mild or moderate alcohol or substance use disorder is not exclusionary
- Pregnancy; less than 3 months postpartum; or less than 3 months since cessation of breastfeeding
Show all 12Show fewer
- Contraindication to magnetic resonance imaging (MRI) or transcranial magnetic stimulation (TMS), including MRI/TMS-incompatible implanted metallic or electronic devices, retained metallic foreign bodies, or other implants determined to be unsafe following MRI/TMS safety review
- History of neurosurgery when incompatible with safe MRI or TMS participation
- Claustrophobia that would prevent completion of MRI
- Inability to lie still in the MRI scanner for approximately 60 minutes
- Vision impairment that cannot be adequately corrected for completion of study procedures
- Initiation of a new psychiatric medication within 4 weeks before enrollment or anticipated inability to maintain a stable medication regimen during study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Erin T Natale, (619) 543-2900, erin.natale@va.gov
Daniel M Stout, PhD, (858) 642-3944, Daniel.Stout@va.gov
About this study
Official title: Salience Network-guided rTMS for Veterans With PTSD
The proposed study will test whether magnetic resonance imaging (MRI)-guided transcranial magnetic stimulation (TMS) can reduce posttraumatic stress disorder (PTSD) symptoms in Veterans. TMS is a noninvasive treatment that uses magnetic pulses to change activity in specific areas of the brain. In this study, MRI will be used to personalize the location of TMS based on brain networks involved in detecting and responding to important or threatening information. Veterans with PTSD will be randomly assigned to receive either active or non-active control TMS over 20 sessions. The study will examine whether active TMS improves PTSD symptoms and changes the brain circuits targeted by treatment. If effective, this approach may help improve and personalize TMS treatment for Veterans with PTSD. This project supports the Department of Veterans Affairs mission of developing more effective, biologically informed treatments for Veterans with PTSD.
Read the detailed description
Posttraumatic stress disorder (PTSD) is a common and debilitating condition among Veterans. Although evidence-based psychological and pharmacological treatments are effective for many individuals, a substantial proportion of patients continue to experience clinically significant symptoms after treatment, underscoring the need for alternative interventions. PTSD is associated with alterations in brain circuits involved in threat detection, emotional regulation, cognitive control, and physiological arousal. One brain network implicated in these processes is the salience network, particularly the anterior insula, which contributes to detecting and responding to behaviorally important internal and external information.
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive neuromodulation technique that uses magnetic pulses to influence activity in targeted brain regions. Previous studies suggest that rTMS targeting the dorsolateral prefrontal cortex (DLPFC) may reduce PTSD symptoms, but treatment effects vary substantially across individuals. One potential source of this variability is that standard anatomical stimulation locations may not consistently engage the same PTSD-relevant functional brain circuits across individuals. Functional magnetic resonance imaging (fMRI)-guided neuronavigation provides an approach for personalizing stimulation locations based on each individual's functional brain organization.
The purpose of this study is to determine whether personalized, neuronavigation-guided rTMS targeting a brain circuit associated with salience network function can improve PTSD symptoms and modulate PTSD-relevant neural circuitry in Veterans. Each participant's stimulation location within the right DLPFC will be personalized using resting-state fMRI based on the functional connectivity between the right DLPFC and right anterior insula, a key region of the salience network.
The study is a double-blind, randomized controlled trial that will enroll up to 82 Veterans with PTSD. Participants will be randomly assigned to receive either active rTMS or control (sham) stimulation. Treatment will consist of 20 stimulation sessions delivered over four weeks. Participants will complete MRI assessments before and after treatment to evaluate changes in salience network activity and functional connectivity.
The study will evaluate whether active rTMS, compared with control stimulation, produces improvements in PTSD symptoms and changes in neural and physiological measures associated with PTSD. In addition to clinical symptoms and fMRI measures, the study will assess autonomic nervous system function using measures including heart rate variability and skin conductance response. The overarching hypothesis is that personalized stimulation of a DLPFC location functionally connected with the anterior insula will modulate salience network circuitry and that these neural changes will be associated with improvement in PTSD symptoms.
This study is designed to clarify the neural mechanisms through which rTMS may affect PTSD symptoms and to determine whether individualized, fMRI-guided targeting can reliably engage PTSD-relevant brain circuitry. Findings may help inform the development of more precise and mechanistically informed neuromodulation treatments for Veterans with PTSD.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Active MRI-Guided intermittent theta burst stimulation (iTBS), Sham MRI-Guided intermittent theta burst stimulation (iTBS)
- Keywords
- PTSD, Veterans, Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation, Intermittent Theta Burst Stimulation, iTBS, Salience Network, Anterior Insula, Dorsolateral Prefrontal Cortex, Functional Connectivity, Functional Magnetic Resonance Imaging, Neuronavigation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active MRI-Guided intermittent theta burst stimulation (iTBS)Device
Also called MagVenture TMS Therapy System
Active intermittent theta burst stimulation (iTBS) will be delivered using the MagVenture TMS Therapy System. An individualized right dorsolateral prefrontal cortex treatment target will be identified using MRI/fMRI-based functional connectivity with the right anterior insula of the salience network. The Brainsight neuronavigation system will be used to localize the individualized target and guide TMS coil positioning. Each treatment session will consist of 600 pulses. Participants will receive 20 treatment sessions, scheduled 5 days per week for 4 weeks. When needed because of scheduling interruptions, the 20 sessions may be completed within up to 6 weeks.
Sham MRI-Guided intermittent theta burst stimulation (iTBS)Device
Also called MagVenture TMS Therapy System
Sham intermittent theta burst stimulation (iTBS) will be delivered using the MagVenture TMS Therapy System. An individualized right dorsolateral prefrontal cortex treatment target will be identified using MRI/fMRI-based functional connectivity with the right anterior insula of the salience network. The Brainsight neuronavigation system will be used to localize the individualized target and guide TMS coil positioning. Sham stimulation will use the same treatment location, session structure, and treatment schedule as the active condition and is designed to mimic the treatment experience without delivering active therapeutic stimulation. Participants will receive 20 sham treatment sessions, scheduled 5 days per week for 4 weeks. When needed because of scheduling interruptions, the 20 sessions may be completed within up to 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active MRI-Guided intermittent theta burst stimulation (iTBS) | Experimental | Participants randomized to this arm will receive 20 sessions of active intermittent theta burst stimulation (iTBS), scheduled 5 days per week for 4 weeks. When needed because of scheduling interruptions, the 20 sessions may be completed within up to 6 weeks. Treatment will be delivered to an individualized right dorsolateral prefrontal cortex target identified using MRI/fMRI-based functional connectivity. Receives: Device: Active MRI-Guided intermittent theta burst stimulation (iTBS) |
| Sham MRI-Guided intermittent theta burst stimulation (iTBS) | Sham comparator | Participants randomized to this arm will receive 20 sessions of sham intermittent theta burst stimulation (iTBS), scheduled 5 days per week for 4 weeks. When needed because of scheduling interruptions, the 20 sessions may be completed within up to 6 weeks. The same individualized MRI/fMRI-guided treatment location and treatment schedule will be used as in the active arm. Receives: Device: Sham MRI-Guided intermittent theta burst stimulation (iTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
The CAPS-5 is a clinician-administered interview used to assess PTSD symptoms according to DSM-5 criteria. Total PTSD symptom severity scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity. The outcome is change in CAPS-5 total severity score from baseline to the post-treatment assessment.
Measured: Baseline and immediately following completion of treatment (approximately Week 4-6)
Change in Anterior Insula Resting-State Functional Connectivity
Resting-state functional MRI will be used to assess functional connectivity of the anterior insula (aINS). The aINS seed will be defined using the region used for personalized TMS targeting. Functional connectivity is measured as the relationship between the aINS blood-oxygen-level-dependent (BOLD) time series and BOLD time series to the brain. Higher association means higher functional connectivity. The outcome is change in aINS resting-state functional connectivity from the pre-treatment to post-treatment MRI assessment.
Measured: Baseline and immediately following completion of treatment (approximately Week 4-6)
Secondary outcomes (3)
Change in Brain Activation During the Anticipation Task
Task-based functional MRI will be used to assess blood-oxygen-level-dependent (BOLD) activation during the Anticipation task. Higher BOLD response indicates greater activation. The outcome is change in task-related BOLD activation from the pre-treatment to post-treatment MRI assessment.
Measured: Baseline and immediately following completion of treatment (approximately Week 4-6)
Change in Heart Rate Variability
Photoplethysmography (PPG) will be used to derive inter-beat intervals for heart rate variability (HRV) analysis. HRV will be quantified as an index of beat-to-beat variation in cardiac activity. The outcome is change in HRV from the pre-treatment to post-treatment assessment.
Measured: Baseline and immediately following completion of treatment (approximately Week 4-6)
Differential Change in CAPS-5 PTSD Symptom Cluster Severity
The CAPS-5 assesses PTSD symptoms across four DSM-5 symptom clusters: intrusion, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. Symptom severity within each cluster is calculated by summing the CAPS-5 severity ratings for symptoms within that cluster. High scores indicate greater symptom severity. Changes in symptom-cluster severity from baseline to post-treatment will be examined to determine whether treatment effects differ across PTSD symptom clusters.
Measured: Baseline and immediately following completion of treatment (approximately Week 4-6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Jul 2027 (estimated)
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Veterans with PTSD will be randomized in a 1:1 ratio to receive either active or control (sham) repetitive transcranial magnetic stimulation (rTMS). Participants in both groups will complete 20 treatment sessions, with clinical, neuroimaging, and psychophysiological assessments conducted before and after treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Daniel M Stout, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886840
- Sponsor's protocol ID
- MHBP-001-26S
- Other IDs
- 1I02RD002647
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Coded individual participant data underlying publications resulting from this study will be made available after removal of personal identifiers and in accordance with applicable VA requirements. Data sharing will be subject to appropriate privacy protections and any required data use agreements to prevent identification or re-identification of participants.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salience Network-guided rTMS for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT07886840
- Acronym / sponsor ID
- MHBP-001-26S
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, Veterans, Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation, Intermittent Theta Burst Stimulation, iTBS, Salience Network, Anterior Insula
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 21 Oct 2026 (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.
The proposed study will test whether magnetic resonance imaging (MRI)-guided transcranial magnetic stimulation (TMS) can reduce posttraumatic stress disorder (PTSD) symptoms in Veterans. TMS is a noninvasive treatment that uses magnetic pulses to change activity in specific areas of the brain. In this study, MRI will be used to personalize the location of TMS based on brain networks involved in detecting and responding to important or threatening information. Veterans with PTSD will be randomly assigned to receive either active or non-active control TMS over 20 sessions. The study will examine whether active TMS improves PTSD symptoms and changes the brain circuits targeted by treatment. If effective, this approach may help improve and personalize TMS treatment for Veterans with PTSD. This project supports the Department of Veterans Affairs mission of developing more effective, biologically informed treatments for Veterans with PTSD.
Detailed description
Posttraumatic stress disorder (PTSD) is a common and debilitating condition among Veterans. Although evidence-based psychological and pharmacological treatments are effective for many individuals, a substantial proportion of patients continue to experience clinically significant symptoms after treatment, underscoring the need for alternative interventions. PTSD is associated with alterations in brain circuits involved in threat detection, emotional regulation, cognitive control, and physiological arousal. One brain network implicated in these processes is the salience network, particularly the anterior insula, which contributes to detecting and responding to behaviorally important internal and external information.
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive neuromodulation technique that uses magnetic pulses to influence activity in targeted brain regions. Previous studies suggest that rTMS targeting the dorsolateral prefrontal cortex (DLPFC) may reduce PTSD symptoms, but treatment effects vary substantially across individuals. One potential source of this variability is that standard anatomical stimulation locations may not consistently engage the same PTSD-relevant functional brain circuits across individuals. Functional magnetic resonance imaging (fMRI)-guided neuronavigation provides an approach for personalizing stimulation locations based on each individual's functional brain organization.
The purpose of this study is to determine whether personalized, neuronavigation-guided rTMS targeting a brain circuit associated with salience network function can improve PTSD symptoms and modulate PTSD-relevant neural circuitry in Veterans. Each participant's stimulation location within the right DLPFC will be personalized using resting-state fMRI based on the functional connectivity between the right DLPFC and right anterior insula, a key region of the salience network.
The study is a double-blind, randomized controlled trial that will enroll up to 82 Veterans with PTSD. Participants will be randomly assigned to receive either active rTMS or control (sham) stimulation. Treatment will consist of 20 stimulation sessions delivered over four weeks. Participants will complete MRI assessments before and after treatment to evaluate changes in salience network activity and functional connectivity.
The study will evaluate whether active rTMS, compared with control stimulation, produces improvements in PTSD symptoms and changes in neural and physiological measures associated with PTSD. In addition to clinical symptoms and fMRI measures, the study will assess autonomic nervous system function using measures including heart rate variability and skin conductance response. The overarching hypothesis is that personalized stimulation of a DLPFC location functionally connected with the anterior insula will modulate salience network circuitry and that these neural changes will be associated with improvement in PTSD symptoms.
This study is designed to clarify the neural mechanisms through which rTMS may affect PTSD symptoms and to determine whether individualized, fMRI-guided targeting can reliably engage PTSD-relevant brain circuitry. Findings may help inform the development of more precise and mechanistically informed neuromodulation treatments for Veterans with PTSD.
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
- Veterans with PTSD will be randomized in a 1:1 ratio to receive either active or control (sham) repetitive transcranial magnetic stimulation (rTMS). Participants in both groups will complete 20 treatment sessions, with clinical, neuroimaging, and psychophysiological assessments conducted before and after treatment.
| Arm | Type | Receives |
|---|---|---|
| Active MRI-Guided intermittent theta burst stimulation (iTBS) | Experimental | Device: Active MRI-Guided intermittent theta burst stimulation (iTBS)Participants randomized to this arm will receive 20 sessions of active intermittent theta burst stimulation (iTBS), scheduled 5 days per week for 4 weeks. When needed because of scheduling interruptions, the 20 sessions may be completed within up to 6 weeks. Treatment will be delivered to an individualized right dorsolateral prefrontal cortex target identified using MRI/fMRI-based functional connectivity. |
| Sham MRI-Guided intermittent theta burst stimulation (iTBS) | Sham comparator | Device: Sham MRI-Guided intermittent theta burst stimulation (iTBS)Participants randomized to this arm will receive 20 sessions of sham intermittent theta burst stimulation (iTBS), scheduled 5 days per week for 4 weeks. When needed because of scheduling interruptions, the 20 sessions may be completed within up to 6 weeks. The same individualized MRI/fMRI-guided treatment location and treatment schedule will be used as in the active arm. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Veteran status
- Current diagnosis of posttraumatic stress disorder (PTSD), as determined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
- Able to provide informed consent
- Able to speak, read, and write English
- Willing and able to complete 20 intermittent theta burst stimulation (iTBS) treatment sessions, scheduled 5 days per week for 4 weeks, with completion permitted within up to 6 weeks when needed
Key exclusion criteria (12 listed)
- History of a neurological disorder associated with cognitive dysfunction, such as dementia or mild cognitive impairment
- History of traumatic brain injury associated with an estimated loss of consciousness greater than 30 minutes
- Current acute suicidal ideation or recent psychiatric hospitalization when, in the judgment of the study clinician or treating psychiatrist, the condition would interfere with safe study participation
- Current psychotic disorder or bipolar disorder/mania
- Current severe alcohol or substance use disorder; Mild or moderate alcohol or substance use disorder is not exclusionary
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 MRI-Guided intermittent theta burst stimulation (iTBS)Also: MagVenture TMS Therapy SystemActive intermittent theta burst stimulation (iTBS) will be delivered using the MagVenture TMS Therapy System. An individualized right dorsolateral prefrontal cortex treatment target will be identified using MRI/fMRI-based functional connectivity with the right anterior insula of the salience network. The Brainsight neuronavigation system will be used to localize the individualized target and guide TMS coil positioning. Each treatment session will consist of 600 pulses. Participants will receive 20 treatment sessions, scheduled 5 days per week for 4 weeks. When needed because of scheduling interruptions, the 20 sessions may be completed within up to 6 weeks. | Device | Active MRI-Guided intermittent theta burst stimulation (iTBS) |
| Sham MRI-Guided intermittent theta burst stimulation (iTBS)Also: MagVenture TMS Therapy SystemSham intermittent theta burst stimulation (iTBS) will be delivered using the MagVenture TMS Therapy System. An individualized right dorsolateral prefrontal cortex treatment target will be identified using MRI/fMRI-based functional connectivity with the right anterior insula of the salience network. The Brainsight neuronavigation system will be used to localize the individualized target and guide TMS coil positioning. Sham stimulation will use the same treatment location, session structure, and treatment schedule as the active condition and is designed to mimic the treatment experience without delivering active therapeutic stimulation. Participants will receive 20 sham treatment sessions, scheduled 5 days per week for 4 weeks. When needed because of scheduling interruptions, the 20 sessions may be completed within up to 6 weeks. | Device | Sham MRI-Guided intermittent theta burst stimulation (iTBS) |
Primary outcome
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
Time frame: Baseline and immediately following completion of treatment (approximately Week 4-6)
The CAPS-5 is a clinician-administered interview used to assess PTSD symptoms according to DSM-5 criteria. Total PTSD symptom severity scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity. The outcome is change in CAPS-5 total severity score from baseline to the post-treatment assessment.
Change in Anterior Insula Resting-State Functional Connectivity
Time frame: Baseline and immediately following completion of treatment (approximately Week 4-6)
Resting-state functional MRI will be used to assess functional connectivity of the anterior insula (aINS). The aINS seed will be defined using the region used for personalized TMS targeting. Functional connectivity is measured as the relationship between the aINS blood-oxygen-level-dependent (BOLD) time series and BOLD time series to the brain. Higher association means higher functional connectivity. The outcome is change in aINS resting-state functional connectivity from the pre-treatment to post-treatment MRI assessment.
3 secondary outcomes
Change in Brain Activation During the Anticipation Task
Time frame: Baseline and immediately following completion of treatment (approximately Week 4-6)
Change in Heart Rate Variability
Time frame: Baseline and immediately following completion of treatment (approximately Week 4-6)
Differential Change in CAPS-5 PTSD Symptom Cluster Severity
Time frame: Baseline and immediately following completion of treatment (approximately Week 4-6)
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 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Coded individual participant data underlying publications resulting from this study will be made available after removal of personal identifiers and in accordance with applicable VA requirements. Data sharing will be subject to appropriate privacy protections and any required data use agreements to prevent identification or re-identification of participants.
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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.
Daniel M Stout, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active MRI-Guided intermittent theta burst stimulation (iTBS) in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site 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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Daniel M Stout, PhD ((858) 642-3944, Daniel.Stout@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score (time frame: Baseline and immediately following completion of treatment (approximately Week 4-6)). The study lists 2 primary outcomes in all. 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 27 Oct 2026.