Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587659
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-28
Brief Title:
Accelerated Image-Guided Robotically Delivered Transcranial Magnetic Stimulation for Combat PTSD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Accelerated Image-Guided Robotically Delivered Transcranial Magnetic Stimulation for Combat PTSD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Posttraumatic stress disorder PTSD among military service members and veterans is as high as 32 and is the third most service-connected disability resulting in over 15 billion in direct costs over a five-year period According to Clinical Practice Guidelines strong evidence exists for psychotherapies such as prolonged exposure PE for PTSD However psychotherapies are often met with high drop-out rates treatment non-compliance and emotional stress due to trauma recall A successful approach to reduce drop-out rates and maintain efficacy is to compress psychotherapy into daily day-long PE sessions Yet another deficit exists regarding the feasibility of this approach outside of residential treatment facilities which are typically reserved for the most extreme cases The newest study from the our team aimed to augment PE residential treatment with a neuromodulatory treatment image-guided robot-navigated transcranial magnetic stimulation IR-TMS Along with the PE-focused intensive inpatient program IIP-PE participants received IR-TMS targeting the right dorsolateral prefrontal cortex DLPFC daily for 20 consecutive days Results demonstrated superiority of the combined IIP-PEIR-TMS approach compared to IIP-PE and a sham condition However it is not yet established whether a standalone IR-TMS approach will achieve similar results Our goal is to implement an open-label trial of IR-TMS for PTSD in which veterans and active-duty service members with PTSD will receive accelerated IR-TMS throughout a 2-week timeframe Results will be used as a foundation for future extramural funding to scale-up the stand alone IR-TMS intervention for PTSD treatments
Detailed Description:
We propose an open-label 2-week trial of IR-TMS targeting the right anterior dorsolateral prefrontal cortex R-antDLPFC in 30 PTSD participants We will recruit Active-Duty Service Members and Veterans with combat PTSD as determined by the Clinician Administered PTSD Scale for DSM-5 CAPS-5 Participants will be encouraged to complete as many IR-TMS sessions throughout a 2-week time period with a maximum of 4 sessions per day Treatments will be neuro-navigated and adapted for an accelerated TMS treatment schedule Post-Treatment and durability of this treatment effect will be examined throughout the 1-month and 3-month FU assessments Findings from this open-label trial of IR-TMS for PTSD will serve as preliminary data for a larger randomized clinical trial to further identify the stand-alone effects of IR-TMS versus a sham condition
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