Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06003309
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2023-07-11
Brief Title:
Frequency and E-field Enhancement of ITBS for Depression FREED
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Frequency and E-field Enhancement of ITBS for Depression FREED
Status:
RECRUITING
Status Verified Date:
2024-02
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:
FREED
Brief Summary:
The investigators propose a randomized 3-arm double-blinded parallel experimental trial 20 sessions over 4 weeks in 75 patients with TRD The three arms include 1 the combination of a fully Individualized form of intermittent Theta Burst Stimulation iTBS using BOTH the frequency and electric field E-field targeting approaches Ind-iTBS 2 iTBS individualized using E-field targeting only targeted-iTBS and 3 Standard iTBS treatment ie typical iTBS localized to the dorsolateral prefrontal cortex DLPFC using the Beam F3 method Electroencephalography EEG data will be collected at rest and during a working memory task at baseline and at the end of treatment along with clinical assessments of depression severity The target engagement dependent variable of interest in these three arms will be fronto-parietal theta connectivity measured through resting-state EEG The investigators hypothesize that stimulation with Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity than that produced with targeted-TBS and standard iTBS Aim To evaluate the effects of two individualized forms of iTBS ie using BOTH the frequency and E-field individualization Ind-iTBS compared to iTBS individualized for E-field targeting only targeted-iTBS and standard iTBS on fronto-parietal theta connectivity Hypotheses 1 Ind-iTBS will lead to greater changes in fronto-parietal theta connectivity compared to both targeted-iTBS and standard iTBS 2 Ind-iTBS will also lead to a greater reduction in depressive symptoms as defined by the mean reduction in Montgomery Åsberg Depression Rating Scale Scores MADRS compared to both targeted-iTBS and standard iTBS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None