An interventional study of iTBS and cTBS in Unipolar Depression and Bipolar Disorder, sponsored by Jakub Antczak. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Jakub Antczak · Not applicable, Interventional, and Treatment
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.
855 studies on the registry are indexed under Depressive Disorder; 159 are open to participants now.
This study's planned enrollment of 90 is close to the median of 88 across 689 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Jakub Antczak is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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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.
Device: iTBS
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.
Device: cTBS
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.
Device: Sham
Active iTBS over the left DLPFC to induce the long term potentiation of stimulated area.
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.
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.
Time frame: Before intervention - four weeks after finishing intervention.
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.
Time frame: Before intervention - four weeks after finishing intervention.
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.
Time frame: Before intervention - four weeks after finishing intervention.
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.
Time frame: Before intervention - four weeks after finishing intervention.
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.
Time frame: Before intervention - four weeks after finishing intervention.
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.
Time frame: Before intervention - four weeks after finishing intervention.
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.
Time frame: Through study completion, an average of 1 year
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.
Time frame: Through study completion, an average of 1 year
Plan to share: Yes — EEG, EOG, EMG recordings, scans of scales, inventories and questionnaires will be available upon request sent per e-mail to: bstefanowski@ipin.edu.pl
Supporting information: Study protocol, Statistical analysis plan
Time frame: December 2026 - December 2030
Access criteria: For researchers in medical sciences and medical professional upon justification of their request.
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Jakub Antczak