Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression

Официальное название

Multisite Repetitive Transcranial Magnetic Stimulation for Mood, Cognitive Impairment, Anhedonia and Disordered Sleep in Depressive Disorder

Обзор

Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression.

Подробное описание

Depression is one of the most common and disabling disorders, affecting approximately three hundred million people worldwide. Depressive mood is the main symptom, but other symptoms like cognitive impairment, anhedonia or sleep disorders contribute significantly to patients suffering, decrease quality of life and may even lead to suicide attempt. While modern pharmacotherapy can significantly improve symptoms in many patients, still one third of patients remains drug-resistant. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method of inducing brain plasticity. Stimulation over the left and right dorsolateral prefrontal cortex (DLPFC) and possibly over several other areas can improve mood. Only few studies investigated the effect of rTMS on negative psychiatric symptoms, such as anhedonia, sleeplessness or cognitive impairment. In these trials, either the DLPFC or the dorsomedial prefrontal cortex (dmPFC) were stimulated and sometimes other areas such as the insular cortex. The aim of this study is to investigate if a stimulation over both sites (multi-site stimulation) has better therapeutic potential for depressed mood, cognitive impairment, anhedonia and sleep disorders than stimulation over DLPFC alone and placebo.

Вмешательства

• Устройство Active rTMS over the left DLPFC and over the left DMPFC
  Active rTMS over the left DLPFC and over the left DMPFC to induce the long term potentiation of stimulated areas.
• Устройство Active rTMS over the left DLPFC
  Active rTMS over the left DLPFC to induce the long term potentiation of stimulated area.
• Устройство Sham rTMS
  Sham rTMS over the left DLPFC or over the left DLPFC and over the left DMPFC for placebo.

Первичные конечные точки

• Beck Depression Inventory 2 [Срок оценки: Before intervention - four weeks after finishing intervention.]
• Froward digit span [Срок оценки: Before intervention - four weeks after finishing intervention.]
• Language part of Addenbrooke's Cognitive Examination [Срок оценки: Before intervention - four weeks after finishing intervention.]

Вторичные конечные точки (4)

• Dimensional Anhedonia Rating Scale [Срок оценки: Before intervention - four weeks after finishing intervention.]
• Athens Insomnia Scale [Срок оценки: Before intervention - four weeks after finishing intervention.]
• Pittsburgh Sleep Quality Index [Срок оценки: Before intervention - four weeks after finishing intervention.]
• Epworth Sleepiness Scale [Срок оценки: Before intervention - four weeks after finishing intervention.]

Критерии участия

Критерии включения

• severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion
• Hamilton Depression Rating Scale between between 20 and 35 points at inclusion
• The score in the Athens Insomnia Scale eight or more
• The score of three or more points in items 4 and 21 of the Beck Depressions Inventory 2
• Complaining about problems with memory and concentration timely related with the onset of depression

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Польша · 1 центр

• The Education of Research and Development Center, Babinski Clinical Hospital — Krakow

Идентификаторы

NCT: NCT06363981 · JagiellonianU72

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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