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Device

CPT + rTMS for PTSD

Phase 2
Recruiting
Led By John Hart, Jr., 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
Must not have
PTSD-inducing trauma exposure occurring within the last 3 months prior to pre-enrollment evaluation
inability to stop taking any medication that significantly lowers the seizure threshold
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

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I experienced a traumatic event within the last 3 months.
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I cannot stop taking medication that increases my risk of seizures.
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I have a history of seizures.
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I have never had a severe traumatic brain injury or a high risk of seizures.
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I don't have epilepsy, severe head injuries, conditions that could cause seizures, brain tumors, or recent serious substance use issues.
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I do not have a history of stroke, brain blood vessel issues, dementia, Parkinson's, Huntington's, or multiple sclerosis.
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I am not taking any medications or substances that increase my risk of seizures.
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I have undergone rTMS treatment before.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome measures will be measured twice over a period of 61 weeks: baseline, 12-month post-treatment for reporting.

Treatment Details

Study Objectives

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

Trial 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
63 Previous Clinical Trials
106,404 Total Patients Enrolled
Metrocare Services of DallasUNKNOWN
Johns Hopkins UniversityOTHER
2,317 Previous Clinical Trials
14,871,489 Total Patients Enrolled

Media Library

Active rTMS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03932773 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Active rTMS Alone, Sham rTMS + CPT, Active rTMS + CPT
Post-Traumatic Stress Disorder Clinical Trial 2023: Active rTMS Highlights & Side Effects. Trial Name: NCT03932773 — Phase 2
Active rTMS (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03932773 — Phase 2
~51 spots leftby Oct 2025
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