TMS for PTSD and Blood Pressure

June 9, 2026 updated by: Margaret Bublitz, Lifespan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Lifespan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TMS
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
Device: Transcranial magnetic stimulation
Participants will undergo a standard course of TMS treatment (30 sessions/6 weeks).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 6 weeks
Change in 24-hour blood pressure before and after TMS intervention
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PTSD symptoms
Time Frame: 6 weeks
Change in PTSD symptoms from baseline to follow up
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lifespan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1952743

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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