Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep Quality, Sleep Propensity, Daytime Sleepiness, and Fatigue in Depression
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Poland
Institute of Psychiatry and Neurology
RECRUITING
Warsaw
Contact Information
Primary
Bogdan Stefanowski, MD
bstefanowski@ipin.edu.pl
+48 22 45 82 532
Backup
Jakub Antczak, MD
jakub.antczak@uj.edu.pl
+48 12 400 25 50
Time Frame
Start Date:2024-05-15
Estimated Completion Date:2027-05
Participants
Target number of participants:90
Treatments
Active_comparator: iTBS over the left DLPFC
Active iTBS with intensity of 120% of the resting motor threshold recorded from the right first dorsal interosseus will be administered over the left DLPFC. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 900 magnetic pulses will be elicited.
Experimental: cTBS over the right DLPFC
Active cTBS with intensity of 120% of the resting motor threshold recorded from the left first dorsal interosseus will be administered over the right DLPFC. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 1200 magnetic pulses will be elicited.
Sham_comparator: Sham stimulation
Active iTBS or cTBS will be administered over the left or right DLPFC respectively with sham coil. Therapy will include 90 sessions (three sessions in each of 20 consecutive working days - four weeks in total). In every session 900 or 1200 magnetic pulses will be elicited.