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Device

CPT + rTMS for PTSD

N/A

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 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

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

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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

0 / 8Eligibility criteria met