RecruitingNot ApplicableNCT06371352

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


Sponsor

Jakub Antczak

Enrollment

90 participants

Start Date

May 15, 2024

Study Type

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of non-invasive brain stimulation — intermittent vs. continuous Theta Burst Stimulation (TBS) — to see which better improves sleep quality, daytime tiredness, and fatigue in people with depression. Both methods use gentle magnetic pulses applied to the scalp. **You may be eligible if...** - You have a diagnosis of moderate or severe major depressive disorder or bipolar depression (without psychosis) - You score 5 or higher on the Athens Insomnia Scale (meaning you have sleep problems) - Your antidepressant medication has been unchanged for at least one month **You may NOT be eligible if...** - You have metal implants in your head, are pregnant, or have epilepsy (which contraindicates brain stimulation) - You are currently experiencing psychotic symptoms - You have had suicidal thoughts or attempts in the last three months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEiTBS

Active iTBS over the left DLPFC to induce the long term potentiation of stimulated area.

DEVICEcTBS

Active cTBS over the right DLPFC to induce the long term potentiation of stimulated area.

DEVICESham

Sham iTBS or cTBS over the left or right DLPFC respectively for placebo.


Locations(1)

Institute of Psychiatry and Neurology

Warsaw, Poland

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NCT06371352


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