Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression

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.

Inclusion Criteria:

• severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion
• Diagnosis of major depression (F33.1 or F33.2) or bipolar disorder (F31.3 or F31.4).
• The score of the Athens Insomnia Scale five or more
• Unchanged antidepressive pharmacotherapy at least one month prior to inclusion

Exclusion Criteria:

• Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy
• Psychotic symptoms at the time of inclusion
• Suicidal ideations and/or attempts within three months prior to inclusion