Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371352
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-08
Brief Title:
Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep Daytime Sleepiness and Fatigue in Depression
Sponsor:
Jakub Antczak
Organization:
Jagiellonian University
Study Overview
Official Title:
Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep Quality Sleep Propensity Daytime Sleepiness and Fatigue in Depression
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Intermittent and continuous theta-burst stimulation iTBS and cTBS respectively are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia daytime sleepiness and fatigue This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex DLPFC and cTBS over the right DLPFC compared to sham stimulation in treatment of insomnia daytime sleepiness and fatigue in depression
Detailed Description:
Intermittent and continuous theta-burst stimulation iTBS and cTBS respectively are the newer modalities of conventional repetitive transcranial magnetic stimulation rTMS with documented noninferiority in improving mood in depressive disorders The effect of both modalities on other significant depression symptoms has not been studied In this feasibility study investigators aim primarily to assess the safety and therapeutic potential of iTBS over the left dorsolateral prefrontal cortex lDLPFC and cTBS over the right dorsolateral prefrontal cortex rDLPFC on sleep quality sleep propensity fatigue and daytime sleepiness in patients with major and bipolar depression
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