- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02369614
Low -vs- High-Frequency Repetitive TMS of the Right Dorsolateral Prefrontal Cortex in PTSD
Low-Frequency Versus High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Posttraumatic Stress Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- 1 Hz rTMS of the right dorsolateral prefrontal cortex
- 10 Hz rTMS of the right dorsolateral prefrontal cortex
- Sham rTMS of the right dorsolateral prefrontal cortex
- OASIS treatment as usual
Treatment will be administered in 10 daily sessions, conducted on weekdays, for 2 consecutive weeks. .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active Comparator:1 Hz rTMS
Active Comparator: 1 Hz rTMS
|
1 Hz rTMS
|
Active Comparator: Active Comparator:10 Hz rTMS
|
10 Hz rTMS
|
Sham Comparator: Sham Comparator:Sham rTMS
Sham Comparator: Sham rTMS
|
Sham rTMS
|
No Intervention: OASIS treatment as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4
Time Frame: Baseline and Week 4
|
Clinician Administered PSTD Scale (CAPS)
|
Baseline and Week 4
|
Collaborators and Investigators
Investigators
- Principal Investigator: Donald Hurst, MD, NMCSD
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMCSD.2014.0061
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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