Personalized TACS to Reduce Rumination in Patients with Active Suicidal Ideation

Официальное название

Modulating Alpha-connectivity in Patients with Active Suicidal Ideation Using Transcranial Alternating Current Stimulation

Обзор

The goal of this clinical trial is to determine whether modulating default mode network (DMN) alpha connectivity using transcranial alternating current stimulation (tACS) can reduce rumination and, in turn, mitigate feelings of entrapment and suicidal ideation in individuals with active suicidal ideation and depression. The main questions it aims to answer are: 1. Is personalized tACS stimulation of the DMN associated with reduced rumination 24 hours after stimulation? 2. Does a reduction in rumination result in lower feelings of entrapment and suicidal ideation? 3. Does personalized tACS stimulation of the DMN lead to a reduction of DMN alpha connectivity? Researchers will compare active tACS stimulation to sham stimulation to assess whether modulating alpha connectivity has a specific effect on rumination, entrapment, suicidal ideation, and DMN alpha connectivity. Participants will: * Receive either active or sham tACS stimulation during stimulation sessions, but all participants will receive active tACS at least once. * Complete self-report measures of rumination, entrapment, and suicidal ideation before and after stimulation. * Undergo EEG recordings to assess changes in DMN alpha connectivity. This clinical trial will be preceded by a pilot study in healthy participants with an anticipated completion of data collection in August 2025.

Вмешательства

• Процедура Sham alpha-tACS
  A sinusoidal ± 2mA current adjusted to the individual alpha peak frequency with in-phase stimulation at parieto-occipital brain areas and anti-phase stimulation in frontal brain areas. The stimulation will involve a 10s ramp-up, followed by an immediate 10s ramp-down (no stimulation afterwards).
• Процедура alpha-tACS
  Active tACS with a sinusoidal ± 2mA current adjusted to the individual alpha peak frequency with a 10s ramp-up and 10s ramp-down after stimulation. In-phase stimulation will be applied to parieto-occipital brain areas and anti-phase stimulation will be applied to frontal brain areas

Первичные конечные точки

• EEG alpha functional connectivity (phase synchronization) [Срок оценки: Pre-stimulation to post-stimulation at visit 2 (up to 1 hour)]
• Response style questionnaire (RSQ-10D) [Срок оценки: Visit 2 to visit 3 (24 hours)]

Вторичные конечные точки (10)

• Beck Scale for Suicide Ideation (BSS) [Срок оценки: Visits 2-5 (24 hours)]
• Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I) [Срок оценки: Visits 2-5 (24 hours)]
• Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I) [Срок оценки: Visits 2 & 4 (up to 1 hour)]
• Clinical Global Impression of Suicidality (CGI-SS-R) [Срок оценки: Visits 2-5 (24 hours)]
• Clinical Global Impression of Suicidality (CGI-SS-R) [Срок оценки: Visits 2 & 4 (up to 1 hour)]
• Suicidal Intent Visual Analogue Scale (S-VAS) [Срок оценки: Visits 2-5 (24 hours)]
• Suicidal Intent Visual Analogue Scale (S-VAS) [Срок оценки: Visits 2 & 4 (up to 1 hour)]
• Short Defeat and Entrapment Scale (SDES) [Срок оценки: Visits 2-5 (24 hours)]
• Beck Depression Inventory (BDI-II) [Срок оценки: Visits 2-5 (24 hours)]
• Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: Visits 2-5 (24 hours)]

Критерии участия

Критерии включения

• Active suicidal ideation defined by a score ≥3 on item #10 of the Montgomery-Asberg Depression Rating Scale (MADRS) and a combined score of ≥2 on items #4 + #5 of the Beck Scale for Suicide Ideation (BSS)
• Clinical diagnosis of a mild to severe depressive episode without psychotic symptoms
• Voluntary patients at inpatient, outpatient, or day-clinic units of mental health care settings in the greater Zurich area
• Aged 18-65 years
• Fluent in German
• Ability to give written informed consent

Критерии исключения

• Mental disorders due to known physiological conditions
• Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders
• Intellectual disabilities
• Concurrent vagus nerve stimulation, transcranial magnetic stimulation, electro-convulsive therapy, or treatment with nitrous oxide
• Pregnancy or breast-feeding
• Chronic migraines
• Metal implants or any other factor that - in the investigators' judgment - would unduly affect patient safety or compliance during this study

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Bankwitz A, Ruesch A, Adank A, Hormann C, Villar de Araujo T, Schoretsanitis G, Kleim B, Olbrich S. EEG source functional connectivity in patients after a recent suicide attempt. Clin Neurophysiol. 2023 Oct;154:60-69. doi: 10.1016/j.clinph.2023.06.025. Epub 2023 Jul 22. PMID 37562347

Идентификаторы

NCT: NCT06832124 · 2024-02027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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