Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544408
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the clinical efficacy of an accelerated TMS accel-TMS protocol that rapidly addresses PTSD symptoms with 1 week 25 sessions over 5 days of condensed treatment
Detailed Description:
This study will have three phases an acute phase 1 week of treatments an extension phase second week of treatments and a long-term observational follow-up phase of 6 months
The acute phase will be a three-arm randomized sham-controlled trial with Arm 1 active left dl-PFC accel-TMS Arm 2 active dm-PFC accel-TMS and Arm 3 sham accel-TMS half with sham dl-PFC and half with sham dm-PFC coil positioning
In the subsequent extension phase all participants will receive active left dl-PFC accel-TMS For the follow-up phase clinical outcomes will be assessed at 1-month 3-months and 6-months The primary outcome measure will be the CAPS-5
A range of other secondary outcome measures will also be included
The acute phase will be a three-arm randomized sham-controlled trial with Arm 1 active left dl-PFC accel-TMS Arm 2 active dm-PFC accel-TMS and Arm 3 sham accel-TMS half with sham dl-PFC and half with sham dm-PFC coil positioning
In the subsequent extension phase all participants will receive active left dl-PFC accel-TMS For the follow-up phase clinical outcomes will be assessed at 1-month 3-months and 6-months The primary outcome measure will be the CAPS-5
A range of other secondary outcome measures will also be included
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