Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05512143 |
| Other study ID # |
1952743 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2024 |
| Est. completion date |
February 1, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Lifespan |
| Contact |
Margaret Bublitz, PhD |
| Phone |
14017937884 |
| Email |
margaret_bublitz[@]brown.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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 30 sessions (5 days/week, 6 consecutive weeks) of 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 safety and acute effects of TMS on autonomic function (Aim 1),
examine change in 24-hour blood pressure following a standard course of TMS (Aim 2), 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 3). 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.
