Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04872465
Status:
RECRUITING
Last Update Posted:
2023-01-17
First Post:
2021-05-02
Brief Title:
TBS Over DLPFC in Elderly Refractory Depression
Sponsor:
Kaohsiung Veterans General Hospital
Organization:
Kaohsiung Veterans General Hospital
Study Overview
Official Title:
Efficacy of Bilateral Dorsolateral Prefrontal Theta-burst Stimulation in Elderly Refractory Depression a Randomized Sham-controlled Study
Status:
RECRUITING
Status Verified Date:
2023-01
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 study aim to examine the effect of Thea-burst stimulation over bilateral dorsolateral prefrontal cortex DLPFC among patients with LLD on mood condition and relevant biomarkers
Detailed Description:
Thea-burst stimulation TBS is a novel form of rTMS providing greater modulation effect on neural activity So far no study was conducted to use TBS as treatment in LLD Therefore we aim to examine the effect of TBS over bilateral dorsolateral prefrontal cortex DLPFC among patients with LLD on mood condition and relevant biomarkers The study used a two-arm parallel double-blind randomized and sham-controlled design We plan to enroll sixty patients with LLD thirty for active intervention and thirty for sham-controlled group An Magstim Rapid2 stimulator with eight-figure coil was used for stimulation Location of brain area are based on bilateral DLPFC 3-pulse 50-Hz bursts was given every 200ms at 5 Hz and an intensity of 80 active motor threshold was settled We initially used cTBS continuous TBS over right DLPFC with 120-s train of uninterrupted bursts 1800 pulses in each session per day After that we continuous use iTBS intermittent TBS iTBS over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s 1800 pulses Each patient received daily stimulation for two weeks with total ten sessions The primary outcomes were change of depression severity including response and remission rate Secondary outcome were biomarkers related to depression Assessments were administered at baseline immediately after 5 and 10 sessions of stimulation and 3 months after the completion of stimulation
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