NCT05512143

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
21mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Feb 2024Jan 2028

First Submitted

Initial submission to the registry

August 19, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

August 19, 2022

Last Update Submit

February 3, 2026

Conditions

Post-traumatic Stress DisorderHypertension

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

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

    6 weeks

Secondary Outcomes (1)

  • PTSD symptoms

    6 weeks

Study Arms (1)

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

Device: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulationDEVICE

Participants will undergo a standard course of TMS treatment (30 sessions/6 weeks).

TMS

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lifespan Hospital

Providence, Rhode Island, 02904, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticHypertension

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Psychologist

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 23, 2022

Study Start

February 15, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)