Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06166082
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2023-12-03
Brief Title:
Stanford Neuromodulation Therapy SNT for the Treatment-Resistant Depression
Sponsor:
Changping Laboratory
Organization:
Changping Laboratory
Study Overview
Official Title:
Stanford Neuromodulation Therapy SNT for the Treatment-Resistant Depression A Study Multicenter Randomized Double-blind Placebo Parallel Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-12
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:
This study is a multicenter randomized double-blind and sham-controlled trial using the identical protocol as the SNT to replicate the antidepressant efficacy of SNT for TRD Patients will be recruited and randomly assigned 11 ratio to receive active or sham groups from 5 hospitals in China The interventions will last for 5 days and both groups will be followed up for 8 weeks on the same time schedules During the intervention and at least the first 4 weeks of post-treatment participants will keep a stable antidepressant regimen The individualized SNT target in the left dorsolateral prefrontal cortex DLPFC will be generated from 30 minutes of resting-state functional MRI collected at baseline
Detailed Description:
Repetitive Transcranial Magnetic Training rTMS is a non-invasive neuromodulation that has been approved by the Food and Drug Administration FDA for treating patients with treatment-resistant depressionTRD In 2022 the US FDA approved a high-dose intervention called Stanford Neuromodulation Therapy SNT to achieve rapid relief of patient symptoms in TRD This therapy involves 10 1800 pulse Intermittent Theta Burst Stimulation iTBS interventions per day for consecutive 5 days on the dorsolateral prefrontal cortex DLPFC with 50 minutes inter-session intervals At the end of the SNT intervention the response rate reached 714 133 in the sham group At the 4th week follow-up after treatment the response rate was 692 71 in the sham group This therapy has the advantage of quickly taking effect in the treatment of patients with TRD in a short period However there are also some limitations with this therapy such as the need to undergo 10 high-dose interventions with 1800 pulses per day which takes about 9 hours and may reduce patient compliance with the treatment In addition this study is a single-center small sample trial 14 cases with active and 15 cases with sham stimulation The SNT therapy brings confidence to TRD patients its efficacy and safety need to be verified in multicenter randomized double-blind placebo-parallel controlled clinical trials
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