Post-traumatic Stress DisorderNCT05512143
TMS for PTSD and Blood Pressure
A study testing Transcranial magnetic stimulation in people with Post-traumatic Stress Disorder and Hypertension, run by Lifespan at 1 site in United States.
Trial summary
In this randomized clinical trial, we will test the short and longer term effects of repetitive transcranial magnetic stimulation (TMS) on blood pressure among reproductive aged female participants with elevated symptoms of post-traumatic stress disorder and hypertension. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Post-traumatic Stress Disorder, Hypertension
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- English speaking, 18-44 years old, PCL-5 score of > 31 at enrollment or PHQ2 > 3 at enrollment, physician-diagnosed hypertension, in stable psychiatric treatment
Who cannot join
- pregnant; active suicidality or psychosis; bipolar I disorder; a seizure disorder and/or seizure disorder in a first degree relative; any metal in the skull; greater than moderate substance use disorder (except nicotine or cannabis) in the prior 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting the Brain-heart Axis With TMS Among Reproductive Aged Women With PTSD
In this randomized clinical trial, we will test the short and longer term effects of repetitive transcranial magnetic stimulation (TMS) on blood pressure among reproductive aged female participants with elevated symptoms of post-traumatic stress disorder and hypertension.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of death and disability for women in the United States. Posttraumatic Stress Disorder (PTSD) affects 1 in 20 reproductive aged women and significantly increases risk CVD. In the perinatal period, cardiovascular complications account for one third of maternal deaths, and emerging evidence indicates that PTSD increases risk for pregnancy-related CVD. As well, exposure to cardiovascular complications in pregnancy increases risk for CVD later in life. Therefore, effective treatment of PTSD in reproductive aged women, prior to disease, holds significant potential to decrease risk for CVD onset across the life course. Repetitive transcranial magnetic stimulation (TMS) is a safe, non-invasive, promising novel approach to treat PTSD and reduce risk for CVD. TMS dramatically reduces PTSD symptoms, and a single session of non-invasive brain stimulation methods, including TMS, reduce heart rate and blood pressure, and increase heart rate variability. However, lack of knowledge on the long-term autonomic benefits of TMS prevents utilization of this intervention for patients at risk for CVD. In this COBRE Center for Neuromodulation pilot study, we aim to determine the acute and longer-term effects of TMS on blood pressure in women at risk for CVD. We propose a single arm trial of TMS among 20 women with elevated PTSD symptoms who also have a diagnosis of hypertension. All participants will receive active TMS to the left dorsolateral prefrontal cortex (DLPFC) administered at 10Hz, 120% of motor threshold, 3000 pulses per session. At the first TMS session, blood pressure, heart rate, and heart rate variability will be monitored for 20 minutes before, during, and after TMS to evaluate acute cardiovascular changes to TMS. Throughout the intervention and at 1-month post intervention, participants will complete 24-hour blood pressure monitoring and PTSD symptom assessments to enable examination of longer-term effects of TMS on blood pressure, as well as test the temporal associations between change in PTSD symptoms and blood pressure. The specific aims of the study are to: examine change in 24-hour blood pressure following a standard course of TMS (Aim 1), and examine if change in PTSD symptoms is associated with changes in 24-hour blood pressure among reproductive aged women with elevated PTSD symptoms (Aim 2). The current proposal is closely aligned with the research priorities described by the NHBLI working group on hypertension to 1) support clinical trials for early intervention for high blood pressure, particularly in younger populations, and 2) support studies related to the role of sex differences in the complications of hypertension and hypertension in pregnancy. Results from this pilot project will establish a new line of inquiry in neuromodulation for PI Bublitz and will provide essential pilot data for a future R01 application to conduct a mechanistic sham-controlled clinical trial of TMS for treatment of PTSD and hypertension in at-risk women.
- Conditions
- Post-traumatic Stress Disorder, Hypertension
- Being tested
- Transcranial magnetic stimulation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
Participants will undergo a standard course of TMS treatment (30 sessions/6 weeks).
| Study group | Role | What they receive |
|---|---|---|
| TMS | Experimental | Participants will receive active TMS to the left dorsolateral prefrontal cortex (DLPFC). Right DLPFC will be targeted using a modification of the Beam method. TMS will be administered at 10Hz, 120% of motor threshold, 3000 pulses per session Receives: Device: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Change in 24-hour blood pressure before and after TMS intervention
Measured: 6 weeks
Secondary outcomes (1)
PTSD symptoms
Change in PTSD symptoms from baseline to follow up
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start15 Feb 2024
- Primary completion31 Dec 2025
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Bublitz, Lifespan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512143
- Sponsor's protocol ID
- 1952743
- Status last verified
- Jun 2026
- First submitted
- 19 Aug 2022
- Last updated
- 11 Jun 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Brain-heart Axis With TMS Among Reproductive Aged Women With PTSD
- ClinicalTrials.gov ID
- NCT05512143
- Acronym / sponsor ID
- 1952743
- Conditions
- Post-traumatic Stress Disorder, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- LifespanUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 23 Aug 2022 (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.
In this randomized clinical trial, we will test the short and longer term effects of repetitive transcranial magnetic stimulation (TMS) on blood pressure among reproductive aged female participants with elevated symptoms of post-traumatic stress disorder and hypertension.
Detailed description
Cardiovascular disease (CVD) is the leading cause of death and disability for women in the United States. Posttraumatic Stress Disorder (PTSD) affects 1 in 20 reproductive aged women and significantly increases risk CVD. In the perinatal period, cardiovascular complications account for one third of maternal deaths, and emerging evidence indicates that PTSD increases risk for pregnancy-related CVD. As well, exposure to cardiovascular complications in pregnancy increases risk for CVD later in life. Therefore, effective treatment of PTSD in reproductive aged women, prior to disease, holds significant potential to decrease risk for CVD onset across the life course. Repetitive transcranial magnetic stimulation (TMS) is a safe, non-invasive, promising novel approach to treat PTSD and reduce risk for CVD. TMS dramatically reduces PTSD symptoms, and a single session of non-invasive brain stimulation methods, including TMS, reduce heart rate and blood pressure, and increase heart rate variability. However, lack of knowledge on the long-term autonomic benefits of TMS prevents utilization of this intervention for patients at risk for CVD. In this COBRE Center for Neuromodulation pilot study, we aim to determine the acute and longer-term effects of TMS on blood pressure in women at risk for CVD. We propose a single arm trial of TMS among 20 women with elevated PTSD symptoms who also have a diagnosis of hypertension. All participants will receive active TMS to the left dorsolateral prefrontal cortex (DLPFC) administered at 10Hz, 120% of motor threshold, 3000 pulses per session. At the first TMS session, blood pressure, heart rate, and heart rate variability will be monitored for 20 minutes before, during, and after TMS to evaluate acute cardiovascular changes to TMS. Throughout the intervention and at 1-month post intervention, participants will complete 24-hour blood pressure monitoring and PTSD symptom assessments to enable examination of longer-term effects of TMS on blood pressure, as well as test the temporal associations between change in PTSD symptoms and blood pressure. The specific aims of the study are to: examine change in 24-hour blood pressure following a standard course of TMS (Aim 1), and examine if change in PTSD symptoms is associated with changes in 24-hour blood pressure among reproductive aged women with elevated PTSD symptoms (Aim 2). The current proposal is closely aligned with the research priorities described by the NHBLI working group on hypertension to 1) support clinical trials for early intervention for high blood pressure, particularly in younger populations, and 2) support studies related to the role of sex differences in the complications of hypertension and hypertension in pregnancy. Results from this pilot project will establish a new line of inquiry in neuromodulation for PI Bublitz and will provide essential pilot data for a future R01 application to conduct a mechanistic sham-controlled clinical trial of TMS for treatment of PTSD and hypertension in at-risk women.
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: Transcranial magnetic stimulationParticipants will receive active TMS to the left dorsolateral prefrontal cortex (DLPFC). Right DLPFC will be targeted using a modification of the Beam method. TMS will be administered at 10Hz, 120% of motor threshold, 3000 pulses per session |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- English speaking, 18-44 years old, PCL-5 score of > 31 at enrollment or PHQ2 > 3 at enrollment, physician-diagnosed hypertension, in stable psychiatric treatment
Key exclusion criteria (1 listed)
- pregnant; active suicidality or psychosis; bipolar I disorder; a seizure disorder and/or seizure disorder in a first degree relative; any metal in the skull; greater than moderate substance use disorder (except nicotine or cannabis) in the prior 6 months
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 stimulationParticipants will undergo a standard course of TMS treatment (30 sessions/6 weeks). | Device | TMS |
Primary outcome
Blood pressure
Time frame: 6 weeks
Change in 24-hour blood pressure before and after TMS intervention
1 secondary outcome
PTSD symptoms
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 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. 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 Transcranial magnetic stimulation in people with Post-traumatic Stress Disorder and Hypertension, run by Lifespan 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 1 inclusion and 1 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 11 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood pressure (time frame: 6 weeks). 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 11 Jun 2026.