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Идёт набор NCT07510880

Home tDCS for the Treatment of Major Depression.

Без фазы С лечением Major Depression Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Accelerated protocol of home Transcranial direct current stimulation, Conventional protocol of home Transcranial direct current stimulation, Conventional protocol of in person Transcranial direct current stimulation.
Кому может быть актуально
Состояния в реестре: Major Depression Disorder. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
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Официальное название

Home tDCS for the Treatment of Major Depression: A Randomised Clinical Trial

Обзор

The purpose of this multicentric randomized controlled trial is to compare the effectiveness and safety of home-based tDCS for the treatment of major depression versus tDCS treatment in a healthcare centre, and explore the effects of an accelerated home-tDCS protocol. The change in depression index at the end of treatment, measured with MADRS, will be the primary outcome.

Вмешательства

  • Устройство Accelerated protocol of home Transcranial direct current stimulation
    Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 3 weeks, daily. (1) 1st week - 3 times per day; (2) 2nd Week - 2 t
  • Устройство Conventional protocol of home Transcranial direct current stimulation
    Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 9 weeks, from Monday to Friday. 1 time per day (total of 42 sessio
  • Устройство Conventional protocol of in person Transcranial direct current stimulation
    Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at the medical facilities. Each session will consist of 20 minutes of stimulation. Dose: 9 weeks, from Monday to Friday. 1 time per day (total of 42 se

Первичные конечные точки

  • MADRS [Срок оценки: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.]
Вторичные конечные точки (12)
  • MADRS [Срок оценки: 2nd week of treatment.]
  • MADRS [Срок оценки: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.]
  • HDRS-17 [Срок оценки: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.]
  • HDRS-17 [Срок оценки: 2nd week of treatment.]
  • HDRS-17 [Срок оценки: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.]
  • HARS [Срок оценки: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.]
  • HARS [Срок оценки: 2nd week of treatment.]
  • HARS [Срок оценки: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.]
  • PHQ9 [Срок оценки: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.]
  • PHQ9 [Срок оценки: 2nd week of treatment.]
  • PHQ9 [Срок оценки: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.]
  • Clinical Global Impression [Срок оценки: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.]

Критерии участия

Критерии включения

  • Spanish or Catalan speakers of both sexes between the ages of 18 and 65.
  • Patients diagnosed with major depression, based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Specifically, patients will be included who meet the criteria for a major depressive episode with a longitudinal diagnosis of major depressive disorder, single or recurrent episode; or bipolar disorder type 1 or 2. Patients must obtain a moderate or higher score, therefore we establish a lower limit of 15 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Alonzo et al., 2019).
  • Patients receiving or not receiving pharmacological treatment for depression will be included, and this will be recorded as an additional variable.
  • Have the ability and willingness to commit to the study team for supervision of the intervention sessions and close monitoring of safety.
  • Demonstrate the acquisition of the ability to properly apply home tDCS independently or with the help of a companion.

Критерии исключения

  • Patients with psychotic, schizoaffective, or personality disorders (both cluster A and B).
  • Patients with a history of neurological disease, intellectual disability, or cognitive impairment (inability to understand instructions or operate equipment).
  • Any exclusion criteria established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016): metal implants or head injuries, any electronic devices such as cochlear implants or cardiac pacemakers. Brain stimulation in the last 6 months. Clinical or family history of epilepsy.
  • Patients with dermatological problems, such as an allergic skin reaction at the electrode site.
  • High risk of suicide. Assessed through an interview with a psychiatrist and the use of the Spanish-validated Columbia Suicide Risk Scale (C-SSRS) (Al-Halabí et al., 2016).
  • Drug or alcohol abuse during the study or in the previous 3 months (except for nicotine).
  • Changes in pharmacological or non-pharmacological treatment (such as structured psychotherapy) during the study or in the 3 months prior to starting the trial.
  • Pregnancy.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Испания · 3 центра
  • Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat
  • Hospital Universitari de Mataró — Mataró
  • Parc Taulí Hospital Universitari — Sabadell

Идентификаторы

NCT: NCT07510880 · PI_2025_05_14_V4

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗