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CPT + rTMS for PTSD
Phase 2
Recruiting
Led By F. Andrew Kozel, MD
Research Sponsored by The University of Texas at Dallas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcome measures will be measured twice over a period of 61 weeks: baseline, 12-month post-treatment
Awards & highlights
Study Summary
This trial will study whether adding rTMS to CPT improves PTSD and depression symptoms, as well as neurophysiological measures, in people with combat-related PTSD.
Who is the study for?
This trial is for post-9/11 veterans with combat-related PTSD. Participants must not have had recent trauma, high suicide risk, seizures, major head injuries, severe substance use in the past 3 months, certain brain conditions or metal implants near the head. Pregnant/nursing individuals and those on seizure-lowering meds are excluded.Check my eligibility
What is being tested?
The study tests combining repetitive Transcranial Magnetic Stimulation (rTMS) with Cognitive Processing Therapy (CPT) to treat PTSD symptoms. It also looks at changes in depression levels, social functioning and brain activity through EEGs and MRIs.See study design
What are the potential side effects?
Possible side effects of rTMS may include discomfort at treatment site, headache, lightheadedness or seizures. CPT generally does not involve physical side effects but can sometimes cause temporary increases in distress due to discussing traumatic events.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ outcome measures will be measured twice over a period of 61 weeks: baseline, 12-month post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome measures will be measured twice over a period of 61 weeks: baseline, 12-month post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment group differences in change from baseline to 6-months post-treatment on the Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual of Mental Disorders (5th edition) (CAPS-5) Total Severity Score
Secondary outcome measures
Treatment group differences from baseline to 10 weeks (9th intervention session) on the Quick Inventory of Depressive Symptomatology
Treatment group differences in change from baseline to 1 month post-treatment in electroencephalography power in response to trauma-specific auditory stimuli
Treatment group differences in change from baseline to 1 month post-treatment in electroencephalography power in response to trauma-specific visual stimuli
+64 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Active rTMS AloneActive Control1 Intervention
30 minutes of 1 Hz rTMS to rDLPFC at 1 session per week over 12 weeks
Group II: Active rTMS + CPTActive Control2 Interventions
30 minutes of 1 Hz rTMS to rDLPFC prior to each CPT session
Group III: Sham rTMS + CPTPlacebo Group2 Interventions
30 minutes of sham repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) prior to each Cognitive Processing Therapy (CPT) session
Find a Location
Who is running the clinical trial?
The University of Texas at DallasLead Sponsor
58 Previous Clinical Trials
105,905 Total Patients Enrolled
Metrocare Services of DallasUNKNOWN
Johns Hopkins UniversityOTHER
2,266 Previous Clinical Trials
14,837,167 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experienced a traumatic event within the last 3 months.You are a military veteran who served in conflicts after September 11, and you have been diagnosed with post-traumatic stress disorder (PTSD) specifically related to combat during that time.I cannot stop taking medication that increases my risk of seizures.I have a history of seizures.You have a history of mental health disorders such as bipolar disorder or psychosis.I have never had a severe traumatic brain injury or a high risk of seizures.I don't have epilepsy, severe head injuries, conditions that could cause seizures, brain tumors, or recent serious substance use issues.I do not have a history of stroke, brain blood vessel issues, dementia, Parkinson's, Huntington's, or multiple sclerosis.I am not fluent in English.I don't have any health issues that would make TMS treatment unsafe for me.I am not taking any medications or substances that increase my risk of seizures.You are at a high risk of attempting suicide.I have undergone rTMS treatment before.You have metal fragments or objects in or around your head that cannot be safely taken out.I am currently in a trial or therapy for PTSD.
Research Study Groups:
This trial has the following groups:- Group 1: Active rTMS Alone
- Group 2: Sham rTMS + CPT
- Group 3: Active rTMS + CPT
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project allow for participants who are senior citizens?
"According to the rules that determine who can and cannot participate in this research, the minimum age is 18 and the maximum age is 60."
Answered by AI
Are there any restrictions on who is eligible to participate in this research?
"This trial will have 330 participants that suffer from moral injury. The ideal candidate is aged between 18 and 60, a veteran of post-9/11 military conflicts."
Answered by AI
Are there still vacancies in this experiment for willing subjects?
"The clinical trial is ongoing and has been accepting candidates since May 1st, 2019. According to the information available on clinicaltrials.gov, the study's organizers made their most recent edits on October 20th, 2020."
Answered by AI
Does Active rTMS have FDA approval to be used as a standalone treatment?
"Active rTMS Alone is considered a phase 2 trial, so it has some data supporting safety but not efficacy. This was given a score of 2."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
The University of Texas at Dallas
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’ve tried other things and so far nothing has helped me with my condition.
PatientReceived 1 prior treatment
Eight years ago, I went in for a routine septoplasty just to straighten my septum to midline. The surgeon butchered me for 11 hours, and just so much damage that it completely destroyed my life 24 seven suffering with breathing issues and no sleeping very traumatic experience he didn’t false find medical records and call me a liar Severe PTSD.
PatientReceived 1 prior treatment
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