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New treatment option for Post Traumatic Stress Disorder
Official title rTMS-augmented Written Exposure Therapy for PTSD
ClinicalTrials.gov ID: NCT05149534
What this study is testing
- What it's testing
- Post-traumatic stress disorder (PTSD) is prevalent and represents a high healthcare burden among Veterans. Repetitive transcranial magnetic stimulation (rTMS) is a brain-based therapy that may be effective for treating PTSD.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- -All veterans are eligible to be included in the study if they meet all the following criteria:
- veteran;
- English-speaking and able to provide written informed consent;
- diagnosed with PTSD;
- between the ages of 18 and 60 years. Participants over age 60 will not be included, as aging is known to impact brain structure, and thus the...
You likely can't join if
- Individuals with history of seizures or other serious neurological history including acquired, developmental or degenerative neurologic illness...
- The effects of rTMS are unknown on fetal development, therefore, women who are pregnant will be excluded.
- Participants will also be screened and excluded if any of the following are met:
- current psychosis including psychotic disorder,
- bipolar disorder,
- schizophrenia; or another severe cognitive or psychiatric disorder;
See the full eligibility criteria
- -All veterans are eligible to be included in the study if they meet all the following criteria:
- veteran;
- English-speaking and able to provide written informed consent;
- diagnosed with PTSD;
- between the ages of 18 and 60 years. Participants over age 60 will not be included, as aging is known to impact brain structure, and thus the potential accuracy of the rTMS target, independently of PTSD.
- Individuals with history of seizures or other serious neurological history including acquired, developmental or degenerative neurologic illness, identified through medical chart review, will be excluded due to potential...
- The effects of rTMS are unknown on fetal development, therefore, women who are pregnant will be excluded.
- Participants will also be screened and excluded if any of the following are met:
- current psychosis including psychotic disorder,
- bipolar disorder,
- schizophrenia; or another severe cognitive or psychiatric disorder;
- positive screen for current suicidal intent and plan [with a score of 2 or 3 on BDI-2 item 9];
- current substance use disorder; or substance use in the last 12 hours before the rTMS session.
- The investigators note that PTSD is often comorbid with traumatic brain injury (TBI) in military veterans who were deployed to a war zone. The investigators will use the Department of Defense and Veterans Affairs...
- Participants with moderate or severe TBI will be excluded.
- Participants with mild traumatic brain injury (mTBI) or concussion will be enrolled. This will enhance the ecological validity of the study.
- Participants with cognitive impairment as evidenced by a Montreal Cognitive Screen (MoCA) less than 23/30 or estimated baseline intellectual ability of a standard score of less than 80 on a word reading test will be...
- Participants on psychotropic medications will not be excluded, but participants will be required to be stable on their medication for at least four weeks prior to beginning the study and throughout the time of study.
- Participants enrolled in long term, supportive psychotherapy (i.e. not an evidence-based psychotherapy (EBP)) may continue to be involved in their treatment throughout the study. However, participants involved in a...
The study team makes the final eligibility decision.
Where it's taking place
- Temple, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Temple, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.