Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475040
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-20
Brief Title:
TMS for Anxiety and Trauma-related Disorders
Sponsor:
Shanghai Mental Health Center
Organization:
Shanghai Mental Health Center
Study Overview
Official Title:
Accelerated Intermittent Theta Burst Stimulation to a Novel DLPFC Target for Anxiety and Trauma-related Disorders a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The present pilot study will apply accelerated intermittent theta burst stimulation aiTBS to a novel transcranial magnetic stimulation TMS target for anxiety derived via causal network mapping
Detailed Description:
Anxiety-related disorders represent the most common class of mental-health disorders and are associated with high rates of non-response and relapse to current treatments Transcranial magnetic stimulation TMS applied to the dorsolateral prefrontal cortex dlPFC has been shown to reduce anxiety comorbid with major depressive disorder MDD However anxiety-specific targets have received insufficient attention
An anxiety specific transcranial magnetic stimulation TMS target was recently derived via causal network mapping and was shown to reduce anxiety versus depression symptoms to a greater extent than the conventional dlPFC target in an MDD sample with comorbid anxiety While potentially promising this target has yet to be trialed in an anxiety-related disorder sample
The current open-label study will be the first to evaluate the preliminary effectiveness and safety of this novel right dorsomedial prefrontal cortex dmPFC TMS target MRI-guided neuronavigation will be used to locate this target in each participant An accelerated intermittent theta-burst aiTBS dosing regimen will be used Based on a 90 resting motor threshold adjusted for cortical depth 50 sessions of iTBS will be administered 1800 pulses per session with a 50-minute inter-session interval and delivered in a schedule of 10 sessions per day for 5 consecutive days Clinical assessments and resting-state functional MRI scans will be conducted before and after aiTBS Heart rate variability HRV and eye-movement measures will be collected before and after aiTBS
An anxiety specific transcranial magnetic stimulation TMS target was recently derived via causal network mapping and was shown to reduce anxiety versus depression symptoms to a greater extent than the conventional dlPFC target in an MDD sample with comorbid anxiety While potentially promising this target has yet to be trialed in an anxiety-related disorder sample
The current open-label study will be the first to evaluate the preliminary effectiveness and safety of this novel right dorsomedial prefrontal cortex dmPFC TMS target MRI-guided neuronavigation will be used to locate this target in each participant An accelerated intermittent theta-burst aiTBS dosing regimen will be used Based on a 90 resting motor threshold adjusted for cortical depth 50 sessions of iTBS will be administered 1800 pulses per session with a 50-minute inter-session interval and delivered in a schedule of 10 sessions per day for 5 consecutive days Clinical assessments and resting-state functional MRI scans will be conducted before and after aiTBS Heart rate variability HRV and eye-movement measures will be collected before and after aiTBS
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