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NCT02158663 · ClinicalTrials.gov registry record · NA
Study Testing if Fast or Slow rTMS is Better for the Treatment of Posttraumatic Stress Disorder (PTSD)
A NA study, sponsored by James A. Haley Veterans Administration Hospital.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT02158663 is a NA study that has completed, run by James A. Haley Veterans Administration Hospital. The registered enrollment target is 44 participants.
The verdict
NCT02158663, a NA study, has completed, sponsored by James A. Haley Veterans Administration Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study Summary
Objectives: The primary objective is to test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score. The secondary objectives include: one, testing which treatment provides a significantly greater improvement in depressive symptoms as measured by change in QIDS score; two, testing whether depression impacts effectiveness of 1 Hz versus 10 Hz rTMS for PTSD symptoms; three, testing which treatment is better tolerated as measured by participant drop out and side effect profiles. Research Design: Randomized single-blind (raters) prospective clinical trial testing the effectiveness 1 Hz rTMS versus 10 Hz rTMS in veterans with PTSD. Methodology: Veterans 18-50 years of age suffering from PTSD with and without depressive symptoms will be recruited from the community as well as mental health clinics at James A. Haley Veterans Administration Hospital. Plan to enroll 50 to have an evaluable sample of approximately 20 in each group. Participants will be consented and undergo screening for safety and appropriateness to be in the trial. Those deemed eligible will be evaluated with clinical measures of function, PTSD, depression, pain, and neurobehavioral symptoms. Participants will be randomized in equal proportion (stratified by significant depression defined as MADRS greater than 19) to one of two active treatments: right prefrontal 1 Hz rTMS versus right prefrontal 10 Hz rTMS. Participants will undergo assessment for safety prior to each treatment. The treatments will be performed 5 days a week for 6 weeks with a 3-week taper consisting of 3 days per week, 2 days per week, and 1 day per week. Clinical evaluations will be performed at baseline, after every five treatments, at the end of treatment, and at 1 and 3 months post treatment. CAPS and IPF scores will be used to determine if there is a signi
Interventions
- DEVICE Repetitive Transcranial Magnetic Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2014-06-06 |
| Est. Completion | 2019-03-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02158663
The ClinicalTrials.gov registry entry for NCT02158663 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James A. Haley Veterans Administration Hospital, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Repetitive Transcranial Magnetic Stimulation is the first listed.
NCT02158663 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02158663 about?
NCT02158663 is a clinical study titled "Study Testing if Fast or Slow rTMS is Better for the Treatment of Posttraumatic Stress Disorder (PTSD)". Objectives: The primary objective is to test whether right prefrontal cortex low frequency 1 Hz rTMS versus right prefrontal high frequency 10 Hz rTMS provides a significantly greater improvement in function as measured by IPF score and PTSD symptoms as measured with CAPS score. The secondary object...
What is the current status of trial NCT02158663?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2014-06-06. Estimated completion is 2019-03-14.
What interventions are being tested in trial NCT02158663?
The interventions under investigation include: Repetitive Transcranial Magnetic Stimulation (DEVICE).
Who is sponsoring clinical trial NCT02158663?
This trial is sponsored by James A. Haley Veterans Administration Hospital, which has 7 total clinical trials registered on ClinicalTrials.gov.
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