Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449326
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-06
Brief Title:
Multimodal Image Analysis and Guidance of Neuromodulation for Trauma-Related Symptoms
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Multimodal Image Analysis and Guidance of Neuromodulation for Trauma-Related Symptoms
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAGNETS
Brief Summary:
MAGNETS is a prospective randomized parallel-design sham-controlled clinical trial of accelerated functional magnetic resonance imaging fMRI-guided intermittent theta burst stimulation iTBS to the right dorsolateral prefrontal cortex dlPFC for chronic symptoms of posttraumatic stress disorder PTSD in a comorbid Veteran population
Detailed Description:
In MAGNETS sixty-four participants will be recruited from the NMVAHCS PTSD programs Polytrauma services and outpatient mental health clinics At study entry Visit 1 participants will undergo baseline demographic behavioral and cognitive assessment and fMRI and diffusion tensor imaging DTI The data analysis team will then determine the image-based target in the right hemisphere Participants will be randomized to either the active n32 or sham n32 group and undergo 50 sessions of iTBS 10xday five days At end of treatment Visit 2 they will repeat all baseline tests including fMRI One- three- and six-month symptom levels will be obtained through phone visits Visits 3-5 to establish longevity and stability of benefit Repeated measures analyses will be performed on behavioral and connectivity variables with clinical age duration head injury history and imaging white matter fiber counts features as covariates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None