Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-28 @ 11:49 PM
Study NCT ID:
NCT06999304
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-15
First Post:
2025-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot TMS in Mild TBI
Sponsor:
HealthPartners Institute
Organization:
Study Overview
Official Title:
Personalized Accelerated Theta Burst Transcardial Magnetic Stimulation in Mild Traumatic Brain Injury
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-07
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:
None
Brief Summary:
Persistent post-concussive symptoms (PPCS) involve an array of physical, cognitive, and behavioral symptoms lasting more than a month after mild traumatic brain injury (mTBI). 34-44% of people with mTBI or concussion present with a considerable burden of PPCS 3-6 months after injury. There is currently no standardized treatment for PPCS, nor FDA approved medication for any neuropsychiatric or neurocognitive symptoms associated with mTBI. Transcranial magnetic stimulation (TMS) shows promise as a treatment for PPCS; however, the current one-size-fits-all approach does not address the heterogeneity of symptoms. We propose utilization of resting state functional MRI (rs-fMRI) guided rTMS to target personalized brain networks burdened with PPCS.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: