PTSDPhase 3RAPID5NCT07167940
Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days
A Phase 3 study testing Transcranial magnetic stimulation in people with PTSD, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Veterans with posttraumatic stress disorder (PTSD) need more effective treatments. Existing options can have limited adherence and can be very time-consuming. As such, alternative interventions are needed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Nov 2026to 6 Dec 2030
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic post-traumatic stress disorder (PTSD), meeting DSM-5 criteria
- Eligible Veterans
- Symptomatic despite ongoing stable treatment (medications, psychotherapy, etc.) for at least 6 weeks before study procedures
- Ongoing medications and psychotherapy will be allowed to continue unchanged during the study
- For safety, participants must meet established screening criteria for magnetic resonance imaging (MRI)
- This is implemented as a conservative measure given the novel application of TBS in this population since MRI involves magnetic fields at a similar intensity to those emitted from the stimulation coil
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- These measures require a patient not to have the following (unless MRI-safe):
- A cardiac pacemaker
- implanted device (deep brain stimulation) or metal in the brain
- cervical spinal cord
- upper thoracic spinal cord
- Willingness to participate in a clinical trial for approximately 4 to 6 months (consisting of a treatment phase with a 4-month follow-up period)
- Veterans must also be willing and able to comply with all study-related procedures and visits and be capable of independently reading and understanding information materials and providing written informed consent
- Sufficient visual and auditory acuity to allow neuropsychological testing
Who cannot join
- Psychiatric Exclusions
- Primary psychotic disorder, bipolar I disorder, and greater than moderate substance use disorder (within the last month, excluding nicotine/caffeine, assessed by a urine drug screen as indicated), determined by the Mini International Neuropsychiatric Interview (MINI)
- Active suicidal intent or plan, as detected on screening instruments or in the investigator team's opinion, is likely to attempt suicide within 6 months
- The presence of any other condition or circumstance that, in the opinion of the investigator team, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments
- Medical Exclusions
- History of neurological disorder (e.g., multiple sclerosis, seizure disorder, etc.) or systemic illness affecting central nervous system (CNS) function (e.g., liver failure, kidney failure, congestive heart failure, metastatic cancer) or that could meaningfully impact cortical excitability
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- Acute illness or unstable chronic illness, e.g., history of severe liver disease (cirrhosis, esophageal varices, ascites, portal hypertension, hepatic encephalopathy)
- Pregnant or breastfeeding and planning to become pregnant within the next 3 months
- Have a mass lesion, cerebral infarct, or other neuroanatomical abnormality located at the transcranial magnetic stimulation (TMS) treatment site (DLPFC)
- a lifetime history of a) seizure disorder b) primary or secondary central nervous system (CNS) tumors c) stroke or d) cerebral aneurysm
- Greater than mild traumatic brain injury (following VA/DoD definitions)
- Inability to read, unable to verbalize understanding, and voluntarily sign the Informed Consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Geoffrey W Goodale, BS, (518) 626-5626, Geoffrey.Goodale@va.gov
Aman Kumar, (650) 493-5000 ext. 68200, Aman.Kumar@va.gov
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
Noah S Philip, MD, 401-273-7100 ext. 2369, Noah.Philip@va.gov
About this study
Official title: RAPID5: Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days
Veterans with posttraumatic stress disorder (PTSD) need more effective treatments. Existing options can have limited adherence and can be very time-consuming. As such, alternative interventions are needed. Transcranial magnetic stimulation (TMS) has been FDA-cleared for depression since 2008 and has recently been cleared to treat smoking cessation and obsessive-compulsive disorder. It has demonstrated promise for reducing PTSD symptom severity but standard TMS has a significant time requirement. This study will compare an accelerated 5-day form of TMS versus sham for PTSD, characterizing efficacy and durability. This project will provide important information that can be implemented in the near term for Veterans with PTSD.
Read the detailed description
The primary research question of the proposed study is: Can transcranial magnetic stimulation (TMS) effectively treat posttraumatic stress disorder in Veterans using a pragmatic accelerated approach? The investigators address the need to improve symptom severity in this population utilizing the RAPID5 TMS protocol which delivers five treatments per day over the course of five days. The proposed four-year randomized controlled trial will compare the RAPID5 protocol to a Sham TMS Control Condition. The primary aim of the proposed research is to evaluate the efficacy of TMS to ameliorate PTSD symptoms in Veterans. The second aim is to examine the durability of PTSD symptom reduction resultant from the RAPID5 protocol. Given the high rate of mild traumatic brain injury (mTBI) among Veterans with PTSD, the exploratory aims of the proposed research seek to assess the contribution of mTBI in the context of PTSD on TMS outcomes.
Exploratory aims of the proposed research are: 1) examine whether mTBI status moderates PTSD symptom reduction, 2) assess whether differences in executive functioning moderate or mediate PTSD symptom reduction in Veterans with and without mTBI, and 3) will RAPID5 result in improved executive functioning in Veterans with PTSD.
These aims will be testing in a double-blind randomized controlled trial which will compare the efficacy of RAPID5 to sham TMS. This trial will include 90 Veterans meeting criteria for PTSD ages 18-70 with half randomized to RAPID5 and half randomized to sham TMS. For the RAPID5 condition, Veterans will receive five treatments per day for five consecutive business days. This protocol is based on evidence from previous work in depression and pilot data collected within the national Clinical TMS Program. Veterans randomized to the sham control condition will receive five treatments per day for five consecutive business days. After completion of the active treatment phase, Veterans will be assessed at two follow-up timepoints: 1 month and 3 months posttreatment.
Participants will complete several assessments, including but not limited to semi-structured clinical interviews, symptom self-report rating measures, quality of life measures, and neuropsychological measures assessing executive functioning. The goal is to provide evidence of the efficacy of an accelerated TMS treatment protocol in reducing PTSD symptom severity, resulting in an easily implementable VA healthcare systemwide implementation of this protocol across the VA enterprise.
- Conditions
- PTSD
- Being tested
- Transcranial magnetic stimulation, Sham transcranial magnetic stimulation
- Keywords
- Post-traumatic Stress Disorder, Transcranial Magnetic Stimulation, Veterans
- 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.
Transcranial magnetic stimulationDevice
Also called TMS
iTBS; 50 hertz (Hz) triplets given at 5 Hz frequency with a cycle time of 2 seconds on and 8 seconds off). There will be 60 cycles for a total of 1800 pulses
Sham transcranial magnetic stimulationDevice
Also called Sham TMS
Sham iTBS; 50 hertz (Hz) triplets given at 5 Hz frequency with a cycle time of 2 seconds on and 8 seconds off). There will be 60 cycles for a total of 1800 pulses
| Study group | Role | What they receive |
|---|---|---|
| Active TMS | Active comparator | Active transcranial magnetic stimulation Receives: Device: Transcranial magnetic stimulation |
| Sham TMS | Sham comparator | Non-active/sham transcranial magnetic stimulation Receives: Device: Sham transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic stress disorder (PTSD) Checklist for the DSM-5
Measure of the number and severity of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate more severe PTSD.
Measured: T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatment
Secondary outcomes (3)
Executive Functioning
A set of several neuropsychological measures used to assess executive functioning skills. Administered measures will be transformed into standard scores in order to compare across various measures and create an overall aggregate score. Range will be -2.50 to 2.50 where higher scores indicate better functioning.
Measured: T1: Baseline, T2: Post-Treatment, & T4 3 months post treatment
Pittsburgh Sleep Quality Index
Measure of sleep disturbance and sleep quality. Adding up the average scores of the seven factors gives a global PSQI score from 0 to 21, with where lower scores denote a healthier sleep quality.
Measured: T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatment
Short-Form-36
Measure of quality of life consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Measured: T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start16 Nov 2026 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion6 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to two parallel groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michelle R Madore, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167940
- Sponsor's protocol ID
- MHBP-001-25S
- Other IDs
- 1I01RD001578-01A2
- Acronym
- RAPID5
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2025
- Last updated
- 5 Oct 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAPID5: Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days
- ClinicalTrials.gov ID
- NCT07167940
- Acronym / sponsor ID
- RAPID5 / MHBP-001-25S
- Conditions
- PTSD
- Keywords
- Post-traumatic Stress Disorder, Transcranial Magnetic Stimulation, Veterans
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 6 Dec 2030 (estimated)
- First posted
- 11 Sep 2025 (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.
Veterans with posttraumatic stress disorder (PTSD) need more effective treatments. Existing options can have limited adherence and can be very time-consuming. As such, alternative interventions are needed. Transcranial magnetic stimulation (TMS) has been FDA-cleared for depression since 2008 and has recently been cleared to treat smoking cessation and obsessive-compulsive disorder. It has demonstrated promise for reducing PTSD symptom severity but standard TMS has a significant time requirement. This study will compare an accelerated 5-day form of TMS versus sham for PTSD, characterizing efficacy and durability. This project will provide important information that can be implemented in the near term for Veterans with PTSD.
Detailed description
The primary research question of the proposed study is: Can transcranial magnetic stimulation (TMS) effectively treat posttraumatic stress disorder in Veterans using a pragmatic accelerated approach? The investigators address the need to improve symptom severity in this population utilizing the RAPID5 TMS protocol which delivers five treatments per day over the course of five days. The proposed four-year randomized controlled trial will compare the RAPID5 protocol to a Sham TMS Control Condition. The primary aim of the proposed research is to evaluate the efficacy of TMS to ameliorate PTSD symptoms in Veterans. The second aim is to examine the durability of PTSD symptom reduction resultant from the RAPID5 protocol. Given the high rate of mild traumatic brain injury (mTBI) among Veterans with PTSD, the exploratory aims of the proposed research seek to assess the contribution of mTBI in the context of PTSD on TMS outcomes.
Exploratory aims of the proposed research are: 1) examine whether mTBI status moderates PTSD symptom reduction, 2) assess whether differences in executive functioning moderate or mediate PTSD symptom reduction in Veterans with and without mTBI, and 3) will RAPID5 result in improved executive functioning in Veterans with PTSD.
These aims will be testing in a double-blind randomized controlled trial which will compare the efficacy of RAPID5 to sham TMS. This trial will include 90 Veterans meeting criteria for PTSD ages 18-70 with half randomized to RAPID5 and half randomized to sham TMS. For the RAPID5 condition, Veterans will receive five treatments per day for five consecutive business days. This protocol is based on evidence from previous work in depression and pilot data collected within the national Clinical TMS Program. Veterans randomized to the sham control condition will receive five treatments per day for five consecutive business days. After completion of the active treatment phase, Veterans will be assessed at two follow-up timepoints: 1 month and 3 months posttreatment.
Participants will complete several assessments, including but not limited to semi-structured clinical interviews, symptom self-report rating measures, quality of life measures, and neuropsychological measures assessing executive functioning. The goal is to provide evidence of the efficacy of an accelerated TMS treatment protocol in reducing PTSD symptom severity, resulting in an easily implementable VA healthcare systemwide implementation of this protocol across the VA enterprise.
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
- Participants are randomly assigned to two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Active TMS | Active comparator | Device: Transcranial magnetic stimulationActive transcranial magnetic stimulation |
| Sham TMS | Sham comparator | Device: Sham transcranial magnetic stimulationNon-active/sham transcranial magnetic stimulation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosis of chronic post-traumatic stress disorder (PTSD), meeting DSM-5 criteria
- Eligible Veterans
- Symptomatic despite ongoing stable treatment (medications, psychotherapy, etc.) for at least 6 weeks before study procedures
- Ongoing medications and psychotherapy will be allowed to continue unchanged during the study
- For safety, participants must meet established screening criteria for magnetic resonance imaging (MRI)
Key exclusion criteria (12 listed)
- Psychiatric Exclusions
- Primary psychotic disorder, bipolar I disorder, and greater than moderate substance use disorder (within the last month, excluding nicotine/caffeine, assessed by a urine drug screen as indicated), determined by the Mini International Neuropsychiatric Interview (MINI)
- Active suicidal intent or plan, as detected on screening instruments or in the investigator team's opinion, is likely to attempt suicide within 6 months
- The presence of any other condition or circumstance that, in the opinion of the investigator team, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments
- Medical Exclusions
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 |
|---|---|---|
| Transcranial magnetic stimulationAlso: TMSiTBS; 50 hertz (Hz) triplets given at 5 Hz frequency with a cycle time of 2 seconds on and 8 seconds off). There will be 60 cycles for a total of 1800 pulses | Device | Active TMS |
| Sham transcranial magnetic stimulationAlso: Sham TMSSham iTBS; 50 hertz (Hz) triplets given at 5 Hz frequency with a cycle time of 2 seconds on and 8 seconds off). There will be 60 cycles for a total of 1800 pulses | Device | Sham TMS |
Primary outcome
Post-traumatic stress disorder (PTSD) Checklist for the DSM-5
Time frame: T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatment
Measure of the number and severity of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate more severe PTSD.
3 secondary outcomes
Executive Functioning
Time frame: T1: Baseline, T2: Post-Treatment, & T4 3 months post treatment
Pittsburgh Sleep Quality Index
Time frame: T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatment
Short-Form-36
Time frame: T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatment
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 5 Oct 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.
Michelle R Madore, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transcranial magnetic stimulation in people with PTSD, run by VA Office of Research and Development at 2 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 14 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 5 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 2 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Michelle R Madore, PhD ((650) 493-5000 ext. 64221, michelle.madore@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic stress disorder (PTSD) Checklist for the DSM-5 (time frame: T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatment). 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 5 Oct 2026.