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Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep Quality, Sleep Propensity, Daytime Sleepiness, and Fatigue in Depression
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Institute of Psychiatry and Neurology
Warsaw, Poland
Start Date
May 15, 2024
Primary Completion Date
December 1, 2026
Completion Date
May 1, 2027
Last Updated
October 15, 2024
90
ESTIMATED participants
iTBS
DEVICE
cTBS
DEVICE
Sham
DEVICE
Lead Sponsor
Jakub Antczak
Collaborators
NCT04480918
NCT07140913
Data Source & Attribution
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