Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-02-05
Brief Title:
pBFS Guided rTMS Over Different Targets for Treatment-Resistant Depression
Sponsor:
Changping Laboratory
Organization:
Changping Laboratory
Study Overview
Official Title:
Personalized Brain Functional Sector-guided rTMS Therapy Over Different Targets for Treatment-resistant Depression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
To explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method in adult patients with moderate and severe depressive disorder Second investigate the neural circuit that responds to the rTMS intervention using individualized brain image analysis which may help to establish an effective target for the neuromodulation of patients with major depressive disorder
Detailed Description:
Stimulation of the dorsolateral prefrontal cortexDLPFC and ventromedial prefrontal cortex DMPFC as target sites for rTMS intervention in depressive disorders has shown some therapeutic efficacy However overall patient response rates remain suboptimal partly because the prefrontal cortex is a large region encompassing multiple functional networks Analyses suggest that targeting different targets within the dorsolateral and ventromedial prefrontal cortex for intervention in depressive disorder patients may activate distinct functional networks Therefore selecting appropriate targets within the prefrontal cortex that accurately modulate the functional networks involved in depressive disorder patients is crucial for achieving effective clinical outcomes Fox et al have demonstrated that clinical response and individualized target sites in the dorsolateral prefrontal cortex are associated with functional connectivity to the subgenual cingulate cortex sgACC However some analyses have indicated that rTMS target sites based solely on minimal sgACC connectivity may not be optimal for all depressive symptoms Therefore identifying individualized stimulation targets that improve core symptoms in depressed patients is important for achieving more effective personalized treatment of depressive disorders This study aims to explore the efficacy and safety of rTMS interventions targeting 40 prefrontal cortex sites in depressive disorder patients and to investigate functional imaging-based mechanisms for optimal stimulation targets
After being informed about the study and potential risks All patients giving written informed consent will undergo a screening period to determine eligibility for study entry At week 0 patients who meet the eligibility requirements will be assigned a random intervention target from 40 prefrontal cortex sites Then all participants will undergo a 14-day rTMS modulation and a week follow-up visit Participants will keep a stable treatment regime during treatment and follow-up
After being informed about the study and potential risks All patients giving written informed consent will undergo a screening period to determine eligibility for study entry At week 0 patients who meet the eligibility requirements will be assigned a random intervention target from 40 prefrontal cortex sites Then all participants will undergo a 14-day rTMS modulation and a week follow-up visit Participants will keep a stable treatment regime during treatment and follow-up
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