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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
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
February 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMarch 14, 2019
March 1, 2019
4.6 years
November 17, 2014
March 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4
Clinician Administered PSTD Scale (CAPS)
Baseline and Week 4
Study Arms (4)
Active Comparator:1 Hz rTMS
ACTIVE COMPARATORActive Comparator: 1 Hz rTMS
Active Comparator:10 Hz rTMS
ACTIVE COMPARATORActive Comparator:10 Hz rTMS
Sham Comparator:Sham rTMS
SHAM COMPARATORSham Comparator: Sham rTMS
OASIS treatment as usual
NO INTERVENTIONOASIS treatment as usual
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald Hurst, MD
NMCSD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- LCDR Donald Hurst, MD, MC USN
Study Record Dates
First Submitted
November 17, 2014
First Posted
February 24, 2015
Study Start
August 1, 2014
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
March 14, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share