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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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
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
Find a Location
Who is running the clinical trial?
LifespanLead Sponsor
40 Previous Clinical Trials
41,068 Total Patients Enrolled