Ignite Creation Date:
2024-05-06 @ 3:45 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02369614
Status:
TERMINATED
Last Update Posted:
2019-03-14
First Post:
2014-11-17
Brief Title:
Low -vs- High-Frequency Repetitive TMS of the Right Dorsolateral Prefrontal Cortex in PTSD
Sponsor:
United States Naval Medical Center San Diego
Organization:
United States Naval Medical Center San Diego
Study Overview
Official Title:
Low-Frequency Versus High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Posttraumatic Stress Disorder
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Staffing issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized placebosham 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
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 1 Hz rTMS of the right dorsolateral prefrontal cortex
2 10 Hz rTMS of the right dorsolateral prefrontal cortex
3 Sham rTMS of the right dorsolateral prefrontal cortex
4 OASIS treatment as usual
Treatment will be administered in 10 daily sessions conducted on weekdays for 2 consecutive weeks
Subjects who qualify will be assigned by block randomization to one of four arms
1 1 Hz rTMS of the right dorsolateral prefrontal cortex
2 10 Hz rTMS of the right dorsolateral prefrontal cortex
3 Sham rTMS of the right dorsolateral prefrontal cortex
4 OASIS treatment as usual
Treatment will be administered in 10 daily sessions conducted on weekdays for 2 consecutive weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None