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This is a randomized placebo/sham controlled, double-blind study investigating the efficacy of high- and low-frequency rTMS applied to the right DLPFC at either 1 Hz, 10 Hz, or sham rTMS as compared to an OASIS treatment as usual group for the treatment of PTSD symptoms.
The study will be carried out within the Overcoming Adversity and Stress Injury Support (OASIS) program administered by Naval Medical Center San Diego (NMSD). OASIS is a residential treatment program developed for active duty service members diagnosed with combat related PTSD. OASIS is a 9 week program in which cohorts of 10 patients undergo a variety of therapeutic activities with a focus on cognitive processing therapy (CPT) of combat trauma conducted in both group and individual formats.
Subjects who qualify will be assigned by block randomization to one of four arms:
Treatment will be administered in 10 daily sessions, conducted on weekdays, for 2 consecutive weeks. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator:1 Hz rTMS | Active Comparator | Active Comparator: 1 Hz rTMS |
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| Active Comparator:10 Hz rTMS | Active Comparator | Active Comparator:10 Hz rTMS |
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| Sham Comparator:Sham rTMS | Sham Comparator | Sham Comparator: Sham rTMS |
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| OASIS treatment as usual | No Intervention | OASIS treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Comparator: 1 Hz rTMS | Other | 1 Hz rTMS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4 | Clinician Administered PSTD Scale (CAPS) | Baseline and Week 4 |
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Inclusion Criteria:
Participant in the OASIS program
Willing and able to give informed consent
Diagnosis of Post-Traumatic Stress Disorder as determined by the CAPS CAPS score of at least 50
Males or females between 18-65 years of age
Exclusion Criteria:
Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Active Substance use
Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety
ECT treatment within the last 30 days Patients with neurological disorder leading to increased intracranial pressure
Participation in other interventional treatment protocols (participants of monitoring/observational studies can be included)
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| Name | Affiliation | Role |
|---|---|---|
| Donald Hurst, MD | NMCSD | Principal Investigator |
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| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Active Comparator: 10 Hz rTMS |
| Other |
10 Hz rTMS |
|
| Sham Comparator: | Other | Sham rTMS |
|