Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376877
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-17
Brief Title:
Connectomic Targeted TMS Target for Refractory Anxiety
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
A Novel TMS Target for Anxiety a Confirmatory Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
ConTRA
Brief Summary:
We will perform a randomized sham-controlled trial of aiTBS to an anxiosomatic circuit in patients with anxiety-related disorders ie panic disorder generalized anxiety disorder social anxiety disorder obsessive-compulsive disorder and post-traumatic stress disorder 80 participants with an anxiety-related disorder defined below will receive 50 active or sham TMS treatments over 5 days following the SAINT protocol which is FDA-cleared for MDD The primary outcome will be the BAI with a modified recall window to reflect the short treatment interval Participants randomized to sham will be offered an open-label crossover extension
Detailed Description:
We recently derived a novel TMS target for anxiety via lesion and brain stimulation mapping methods We prospectively tested this target in a sample of participants with major depressive disorder MDD with comorbid anxiety symptoms and found that it was more effective for anxiety median change 600 vs 398 p001 than the conventional TMS target for MDD with comorbid anxiety While these results are promising it remains unclear how our target works for anxiety-related disorders as opposed to MDD comorbid anxiety symptoms Furthermore we used conventional 10 Hz TMS but accelerated intermittent theta burst stimulation aiTBS has now been shown to improve outcomes and is now an FDA approved treatment protocol Finally we tested the translational hypothesis that stimulating different circuits can modify different behaviors clinical efficacy was a secondary outcome
This double-blinded randomized sham-controlled aiTBS trial will test the efficacy of our novel anxiety target 80 participants with anxiety-related disorders ie panic disorder generalized anxiety disorder social anxiety disorder obsessive-compulsive disorder and post-traumatic stress disorder will receive 50 active or sham TMS treatments over 5 days Changes in anxiety symptomsprocesses will be assessed via validated measures primary outcome measure Beck Anxiety Inventory during treatment and follow-up visits up to one-year post-treatment Participants randomized to sham who do not respond will be offered an open-label crossover extension
This double-blinded randomized sham-controlled aiTBS trial will test the efficacy of our novel anxiety target 80 participants with anxiety-related disorders ie panic disorder generalized anxiety disorder social anxiety disorder obsessive-compulsive disorder and post-traumatic stress disorder will receive 50 active or sham TMS treatments over 5 days Changes in anxiety symptomsprocesses will be assessed via validated measures primary outcome measure Beck Anxiety Inventory during treatment and follow-up visits up to one-year post-treatment Participants randomized to sham who do not respond will be offered an open-label crossover extension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None