AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

United States1 site
  • Lifespan Hospital

    Providence, Rhode Island, 02904

Other trials in United States

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.

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.

Study groups in NCT05512143
Study groupRoleWhat they receive
TMSExperimentalParticipants 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.

  1. Blood pressure

    Change in 24-hour blood pressure before and after TMS intervention

    Measured: 6 weeks

Secondary outcomes (1)
  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.

  1. First posted23 Aug 2022
  2. Study start15 Feb 2024
  3. Primary completion31 Dec 2025
  4. Study completion1 Jun 2026

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in