Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05854706
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2023-04-18
Brief Title:
The Effect of Theta-burst Stimulation on Serum BDNF
Sponsor:
Taipei City Hospital
Organization:
Taipei City Hospital
Study Overview
Official Title:
Antidepressant Effect of Prolonged Intermittent Theta-burst Stimulation on Serum Brain-derived Neurotrophic Factor Levels of Patients With Depression A Randomized Double-Blind Sham-Controlled Study
Status:
RECRUITING
Status Verified Date:
2023-02
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:
None
Brief Summary:
The goal of this clinical trial is to investigate the effect of theta burst stimulation for depression and serum brain-derived neurotrophic factor BDNF in individuals with major depression The main question it aims to answer is whether 10 sessions of theta burst stimulation can influence the serum level of BDNF
Participants will be randomized into active group and sham group Researchers will compare the level of BDNF in these groups
Participants will be randomized into active group and sham group Researchers will compare the level of BDNF in these groups
Detailed Description:
There is an increasing evidence that the BDNF could be involved in the mode of action of antidepressants and perhaps of brain stimulation Brain stimulation methods such as electroconvulsive therapy ECT has been used to treat patients with severe depression and is reported to increase BDNF levels in blood Numerous studies has demonstrated that repetitive transcranial magnetic stimulation rTMS as an alternative to ECT produced the most robust antidepressant effects and is the most widely applied treatment protocol for major depressive disorder MDD Theta-burst stimulation TBS is a novel form of rTMS and has recently emerged as a method with the potential to produce similar anti-depressant effects much more rapidly than traditional repetitive TMS protocols It is presumed that BDNF mediates the therapeutic benefits of brain rTMS but previous results are contradictory
Specific Aims
The study is a four-week randomized double-blind sham-controlled study comparing pre- and post-treatment serum BDNF levels of patients with MDD who receive active or sham of prolonged intermittent TBS piTBS treatment
Method
During the four-week double-blind phase of active or sham piTBS treatment piTBS sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks Symptomatic ratings and serum BDNF measurement are administered at baseline W0 before brain stimulation at the end of Week 2 brain stimulation treatments and at the two-week follow-up after the treatment Week 4 Otherwise the symptomatic changes are also evaluated at the end of Week 1 brain stimulation The study include sixty patients with major depression and all participants are randomly allocated 11 to groups receiving either active or sham piTBS group The aim of the present study is to explore the effect of piTBS therapy on serum BDNF levels and change of depression symptom rating scale as well as their associations in patients with MDD
Specific Aims
The study is a four-week randomized double-blind sham-controlled study comparing pre- and post-treatment serum BDNF levels of patients with MDD who receive active or sham of prolonged intermittent TBS piTBS treatment
Method
During the four-week double-blind phase of active or sham piTBS treatment piTBS sessions are scheduled daily in a 5-day sequence for 10 sessions over two weeks Symptomatic ratings and serum BDNF measurement are administered at baseline W0 before brain stimulation at the end of Week 2 brain stimulation treatments and at the two-week follow-up after the treatment Week 4 Otherwise the symptomatic changes are also evaluated at the end of Week 1 brain stimulation The study include sixty patients with major depression and all participants are randomly allocated 11 to groups receiving either active or sham piTBS group The aim of the present study is to explore the effect of piTBS therapy on serum BDNF levels and change of depression symptom rating scale as well as their associations in patients with MDD
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