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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06371352
• Other study ID #: JagiellonianU73
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Jagiellonian University
• Contact: Bogdan Stefanowski, MD
• Phone: +48 22 45 82 532
• Email: bstefanowski[@]ipin.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Disorders of Excessive Somnolence
• Fatigue
• Sleepiness
• Unipolar Depression

Intervention

Device:
• iTBS
Active iTBS over the left DLPFC to induce the long term potentiation of stimulated area.
• cTBS
Active cTBS over the right DLPFC to induce the long term potentiation of stimulated area.
• Sham
Sham iTBS or cTBS over the left or right DLPFC respectively for placebo.

Locations

Country	Name	City	State
Poland	Institute of Psychiatry and Neurology	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Jakub Antczak	Institute of Psychiatry and Neurology, Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Silber MH, Ancoli-Israel S, Bonnet MH, Chokroverty S, Grigg-Damberger MM, Hirshkowitz M, Kapen S, Keenan SA, Kryger MH, Penzel T, Pressman MR, Iber C. The visual scoring of sleep in adults. J Clin Sleep Med. 2007 Mar 15;3(2):121-31. Erratum In: J Clin Sleep Med. 2007 Aug 15;3(5):table of contents. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory 2	Inventory consisting of 21 items measuring cognitive, affective, somatic, and vegetative symptoms of depression. Each item is scored from 0 to 3, with a higher score denoting more severe depression. Items are related to the criteria from the Diagnostic and Statistical Manual of Mental Disorders-IV. The minimum value of the total score is 0 and the maximum is 63 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.	Before intervention - four weeks after finishing intervention.
Primary	Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index is a questionnaire to identify sleep disturbances. It consists of a combination of Likert-type and open-ended questions, which are later converted to scaled scores. Scores for each question range from 0 to 3, with higher scores indicating greater sleep disturbances. The minimum value of the total score is 0 and the maximum is 21 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.	Before intervention - four weeks after finishing intervention.
Secondary	Brief Psychiatric Rating Scale	An 18-item scale assessing negative symptoms, such as emotional withdrawal (e.g. withdrawal from relations), motor slowness and blunted affect. Each item is rated from 1 to 7 with 7-point Likert scaling, where 7 means the most severe disturbance. The minimum value of the total score is 18 and the maximum is 126 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.	Before intervention - four weeks after finishing intervention.
Secondary	Epworth Sleepiness Scale	An eight-item scale. Each item refers to a situation such as driving a car or sitting quietly. The subject is asked to assess the chance of dosing in each situation, ranging from 0 (no chance) to 3 (dosing very likely). The minimum value of the total score is 0 and the maximum is 24 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.	Before intervention - four weeks after finishing intervention.
Secondary	Fatigue Assessment Scale	A 10-item scale to assess the severity of fatigue. Each item is an expression describing the fatigue, such as: "I am bored by fatigue" or "Mentally I feel exhausted". Each item is answered using a Likert-type scale ranging from 1 (never) to 5 (always). The minimum value of the total score is 10 and the maximum is 50 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.	Before intervention - four weeks after finishing intervention.
Secondary	Quality of Life in Depression Scale	A 34-item, self-reported scale to assess the impact of depression on the quality of life. The scale is scored binomially with higher scores indicating a lower quality of life. The minimum value of the total score is 0 and the maximum is 34 with higher scores meaning worse outcome. Change from the baseline to the measurement done after finishing intervention, to the measurement done two weeks after finishing intervention to the measurement done four weeks after finishing intervention.	Before intervention - four weeks after finishing intervention.
Secondary	Sleep propensity non-rapid eye movement 1 sleep stage	A 23-channel electroencephalography (EEG), 2-channel electrooculogram (EOG) and a chin electromyogram (EMG) recorded through 45 minutes in lying position with eyes closed. The recordings will then be divided into 30 second epochs. Each epoch will be assigned to particular sleep stage or wake, according to standards of sleep staging issued by the American Academy of Sleep Medicine [Silber et al. 2007]. The difference in the latency of non-rapid eye movement 1 sleep stage (the time from light off to the first epoch of the non-rapid eye movement 1 sleep stage) before and after intervention will be assessed.	Through study completion, an average of 1 year
Secondary	Sleep propensity non-rapid eye movement 2 sleep stage	A 23-channel electroencephalography (EEG), 2-channel electrooculogram (EOG) and a chin electromyogram (EMG) recorded through 45 minutes in lying position with eyes closed. The recordings will then be divided into 30 second epochs. Each epoch will be assigned to particular sleep stage or wake, according to standards of sleep staging issued by the American Academy of Sleep Medicine [Silber et al. 2007]. The difference in the latency of non-rapid eye movement 2 sleep stage (the time from light off to the first epoch of the non-rapid eye movement 2 sleep stage) before and after intervention will be assessed.	Through study completion, an average of 1 year