Идёт набор NCT06628752

Deep Brain Stimulation for Obsessive-compulsive Disorder

Без фазы С лечением Obsessive-Compulsive 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: Deep brain stimulation.
Кому может быть актуально: Состояния в реестре: Obsessive-Compulsive 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: Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Deep Brain Stimulation for the Treatment of Severe Obsessive-compulsive Disorder

Обзор

The goal of this clinical trial is to evaluate the treatment method of deep brain stimulation (DBS) in patients diagnosed with severe and treatment-resistant obsessive-compulsive disorder (OCD). DBS will be administered into the brain area of the bed nucleus of stria terminalis (BNST). The main research questions are: * Does active DBS in BNST reduce OCD symptoms (primary outcome)? * Does active DBS in BNST reduce anxiety or depressive symptoms and improve the level of daily function? The participants will be randomized to active or sham DBS in the BNST for six months and we will measure the outcomes before DBS surgery, and six months post-surgery. After the randomization phase, the participants will enter an open-label phase and receive continuous DBS in BNST. Yearly follow-ups will be conducted. The outcomes will be measured through interviews using validated psychometric scales.

Вмешательства

Устройство Deep brain stimulation
Stimulation through a device implanted bilaterally into deep brain structures.

Первичные конечные точки

Yale-Brown Obsessive Compulsive Scale, Y-BOCS [Срок оценки: From enrollment to the end of treatment after 6 months.]

Вторичные конечные точки (5)

Hamilton Anxiety Scale, HAS [Срок оценки: From enrollment to the end of treatment after 6 months.]
Hamilton Depression scale, HAMD [Срок оценки: From enrollment to the end of treatment after 6 months.]
Montgomery Asberg Depression Rating Scale, MADRS [Срок оценки: From enrollment to the end of treatment after 6 months.]
Global Assessment of Functioning, GAF [Срок оценки: From enrollment to the end of treatment after 6 months.]
Clinical Global Impression rating scale, CGI [Срок оценки: From enrollment to the end of treatment after 6 months.]

Критерии участия

Критерии включения

OCD diagnosed according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
The patients should have received at least 16 sessions of cognitive behavioral therapy, tried three different serotonergic antidepressants in adequate doses for three months, and one serotonergic antidepressant in combination with a neuroleptic drug.
Severe OCD symptoms: YBOCS ≥ 25 points.
Substantial incapacity because of his/her symptoms.
Duration of symptoms: 5 years minimum.
Understand the consequences of participation in the study and give informed written consent.