PTSDNCT06271733
TMS for Veterans Attending a 2-week Intensive Outpatient Program for PTSD
A study testing TMS in people with PTSD, run by Rush University Medical Center at 1 site in United States.
Trial summary
The goal of this study is to determine whether complementing regular intensive PTSD treatment with intermittent theta burst stimulation (iTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) can improve treatment response for individuals attending a 2-week intensive outpatient program (IOP) for PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2022to 27 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans or service members between the ages of 18 and 65 who are attending the 2- week Intensive Outpatient Program at the Road Home Program and have not had significant PTSD symptom change based on the PCL-5 during the first week of treatment.
- Participants with an HDRS-21 score ≤ 26 at screening visit
Who cannot join
- Individuals with implants and non-removable metals which prevent them from safely receiving TMS, including:
- Aneurysm clips or coils
- Stents in the head, neck, or brain
- Deep brain stimulators
- Metallic implants in the head, neck, or brain (braces and dental implants do not interfere and are safe for TMS)
- Shrapnel or bullet fragments in or near the head
Show all 17Show fewer
- Facial tattoos with metallic or magnetic-sensitive ink
- Other metal devices or ferromagnetic objects implanted in or near the head
- Pacemakers, intra-cardiac lines, or implanted medical pumps
- Individuals with a history of seizures or epilepsy (except those therapeutically induced by ECT)
- Individuals diagnosed with major, chronic mental health illnesses such as Psychotic Disorders, Bipolar Disorders, and Obsessive Compulsive Disorder
- Individuals with a history of substance abuse within the past six months
- Individuals with significant neurological disorders such as Parkinson's disease, Huntington's chorea, and Multiple sclerosis
- Individuals with unstable physical disease, such as unstable cardiac diseases
- Individuals currently on Benzodiazepine at a dose higher than 3mg or Lorazepam or equivalent.
- Women who are breastfeeding or pregnant
- Individuals with previous TMS treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Intensive PTSD Treatment Combined With Transcranial Magnetic Stimulation: A Pilot Study
The goal of this study is to determine whether complementing regular intensive PTSD treatment with intermittent theta burst stimulation (iTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) can improve treatment response for individuals attending a 2-week intensive outpatient program (IOP) for PTSD.
Read the detailed description
Despite the efficacy of many evidence-based treatments for psychiatric disorders, a large percentage of treatment completers maintain their diagnosis and symptoms after treatment. For veterans with PTSD, approximately 66% of all individuals who successfully complete an evidence-based treatment retain their PTSD diagnosis.
An intervention that has been shown to be effective for non-response to first-line psychotherapies is transcranial magnetic stimulation (TMS). TMS is a safe, noninvasive intervention that uses a magnetic field to modulate cortical activity in brain areas linked to an overactive stress response. When compared to sham conditions which resembles the TMS condition but does not utilize any magnetic fields (i.e., proposed active ingredient), TMS has been associated with reduced depressive symptoms in treatment non-responders. Although the bulk of research examines TMS as a treatment for major depressive disorder, TMS has also shown promise in reducing symptoms of other psychiatric disorders such as PTSD.
In prior research TMS was associated with medium to large reductions in core PTSD symptoms when compared to sham conditions. Symptom reductions achieved via TMS have been demonstrated to persist. A recent study compared Cognitive Processing Therapy (CPT) combined with TMS to CPT with a sham condition and found that CPT combined with TMS was associated with greater PTSD symptom reductions during treatment and at six-month follow-up than CPT combined with a sham condition. This finding suggests that TMS may be beneficial as an augmentation to CPT. However, to our knowledge, previous literature has not yet examined whether TMS improves outcomes for individuals who are likely to not respond to CPT treatment.
Due to the demand for briefer TMS protocols, theta burst stimulation (iTBS) is a variation on TMS. Studies have found iTBS to be more efficient than standard TMS but still associated with significant improvements and low side effects in both depression and PTSD. The present study will utilize the more efficient iTBS protocol applied to the right dorsolateral prefrontal cortex (DLPFC) in order to reduce the length of stay for the participants.
Roughly one in four participants who complete Cognitive Processing Therapy (CPT) in the 2-week intensive outpatient program (IOP) at the Road Home Program at Rush do not report a meaningful reduction in PTSD symptoms and can be classified as non-responders. The present study seeks to determine whether adding iTBS to standard IOP programming is feasible for participants who have not reported reduced symptoms by the end of the first week of treatment (i.e., likely non-responders).
- Conditions
- PTSD
- Being tested
- TMS
- 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.
TMSDevice
2 sessions of iTBS per day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| TMS | Experimental | Not described Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5)
Self-report measure of PTSD symptom severity. Scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Measured: 1 month-follow up
Secondary outcomes (1)
Patient Health Questionnaire-9 (PHQ-9)
Self-report measure of depression symptom severity. Scale ranges from 0 to 27, with higher scores indicating greater depression symptom severity.
Measured: 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start11 Jan 2022
- Primary completion27 Jun 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PTSDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271733
- Sponsor's protocol ID
- 21110503
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2024
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive PTSD Treatment Combined With Transcranial Magnetic Stimulation: A Pilot Study
- ClinicalTrials.gov ID
- NCT06271733
- Acronym / sponsor ID
- 21110503
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Posted 20 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine whether complementing regular intensive PTSD treatment with intermittent theta burst stimulation (iTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) can improve treatment response for individuals attending a 2-week intensive outpatient program (IOP) for PTSD.
Detailed description
Despite the efficacy of many evidence-based treatments for psychiatric disorders, a large percentage of treatment completers maintain their diagnosis and symptoms after treatment. For veterans with PTSD, approximately 66% of all individuals who successfully complete an evidence-based treatment retain their PTSD diagnosis.
An intervention that has been shown to be effective for non-response to first-line psychotherapies is transcranial magnetic stimulation (TMS). TMS is a safe, noninvasive intervention that uses a magnetic field to modulate cortical activity in brain areas linked to an overactive stress response. When compared to sham conditions which resembles the TMS condition but does not utilize any magnetic fields (i.e., proposed active ingredient), TMS has been associated with reduced depressive symptoms in treatment non-responders. Although the bulk of research examines TMS as a treatment for major depressive disorder, TMS has also shown promise in reducing symptoms of other psychiatric disorders such as PTSD.
In prior research TMS was associated with medium to large reductions in core PTSD symptoms when compared to sham conditions. Symptom reductions achieved via TMS have been demonstrated to persist. A recent study compared Cognitive Processing Therapy (CPT) combined with TMS to CPT with a sham condition and found that CPT combined with TMS was associated with greater PTSD symptom reductions during treatment and at six-month follow-up than CPT combined with a sham condition. This finding suggests that TMS may be beneficial as an augmentation to CPT. However, to our knowledge, previous literature has not yet examined whether TMS improves outcomes for individuals who are likely to not respond to CPT treatment.
Due to the demand for briefer TMS protocols, theta burst stimulation (iTBS) is a variation on TMS. Studies have found iTBS to be more efficient than standard TMS but still associated with significant improvements and low side effects in both depression and PTSD. The present study will utilize the more efficient iTBS protocol applied to the right dorsolateral prefrontal cortex (DLPFC) in order to reduce the length of stay for the participants.
Roughly one in four participants who complete Cognitive Processing Therapy (CPT) in the 2-week intensive outpatient program (IOP) at the Road Home Program at Rush do not report a meaningful reduction in PTSD symptoms and can be classified as non-responders. The present study seeks to determine whether adding iTBS to standard IOP programming is feasible for participants who have not reported reduced symptoms by the end of the first week of treatment (i.e., likely non-responders).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Device: TMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veterans or service members between the ages of 18 and 65 who are attending the 2- week Intensive Outpatient Program at the Road Home Program and have not had significant PTSD symptom change based on the PCL-5 during the first week of treatment.
- Participants with an HDRS-21 score ≤ 26 at screening visit
Key exclusion criteria (17 listed)
- Individuals with implants and non-removable metals which prevent them from safely receiving TMS, including:
- Individuals with a history of seizures or epilepsy (except those therapeutically induced by ECT)
- Individuals diagnosed with major, chronic mental health illnesses such as Psychotic Disorders, Bipolar Disorders, and Obsessive Compulsive Disorder
- Individuals with a history of substance abuse within the past six months
- Individuals with significant neurological disorders such as Parkinson's disease, Huntington's chorea, and Multiple sclerosis
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 |
|---|---|---|
| TMS2 sessions of iTBS per day for 5 days | Device | TMS |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5)
Time frame: 1 month-follow up
Self-report measure of PTSD symptom severity. Scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
1 secondary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 1 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for PTSD
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Active, not recruitingObservational study
Trauma-Related Attributions in Trauma Treatment: An Observational Study
PTSD
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Recruiting
Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy
Written Exposure Therapy, Breathing Techniques
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with PTSD, run by Rush University Medical Center 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 2 inclusion and 17 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: finished, as of the sponsor's last update on 20 Feb 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. 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?
Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (time frame: 1 month-follow up). 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 20 Feb 2026.