TMS for PTSD and High Blood Pressure

N/A

Recruiting

Research Sponsored by Lifespan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* 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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how repetitive transcranial magnetic stimulation affects blood pressure in women of reproductive age who have symptoms of post-traumatic stress disorder and high blood pressure.

Who is the study for?

This trial is for English-speaking women aged 18-44 who have PTSD with a PCL-5 score over 33 and diagnosed high blood pressure. They must also show signs of depression (PHQ9 score >5) and be in stable psychiatric treatment.

What is being tested?

The study is examining the effects of repetitive transcranial magnetic stimulation (TMS) on blood pressure in women with PTSD and hypertension, assessing both immediate and long-term outcomes.

What are the potential side effects?

Possible side effects of TMS may include headache, scalp discomfort at the site of stimulation, lightheadedness, or seizures; however, serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood pressure

Secondary study objectives

PTSD symptoms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TMSExperimental Treatment1 Intervention

Participants will receive 30 sessions (5 days/week, 6 consecutive weeks) of 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial magnetic stimulation

2015

Completed Phase 4

~590

0 / 1Eligibility criteria met