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
Jakub Antczak
90 participants
May 15, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- 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
Interventions
Active cTBS over the right DLPFC to induce the long term potentiation of stimulated area.
Sham iTBS or cTBS over the left or right DLPFC respectively for placebo.
Active iTBS over the left DLPFC to induce the long term potentiation of stimulated area.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06371352