Glucose Consumption During Deep Brain Stimulation With Functional [18F]FDG-Brain-PET in Obsessive-Compulsive Disorder

Обзор

The purpose of this randomized, sham-controlled study is to evaluate the effectiveness of DBS therapy in individuals suffering from severe OCD and to investigate DBS treatment with functional \[18F\]FDG-Brain-PET.

Подробное описание

The overall planned study duration per subject is 36 weeks, whereby inclusion is timepoint zero and implantation of DBS will be conducted during the first four study weeks. Patients will then undergo an 8-week open-label active DBS treatment phase followed by a 12-week double blind active or sham treatment and finally a 12-week crossover period with the inverse (active/sham) treatment with at least biweekly study visits. Patients as well as patient handling study psychiatrists will be blinded to active/sham. In case of unbearable aggravation of the symptoms during sham, the sham-period will be shortened to a tolerable length. After maximal 38 weeks all study procedures will be completed, and active DBS treatment will be maintained as long as clinically necessary.

Вмешательства

• Устройство Implantation of a DBS therapy system
  The system is called "Reclaim DBS Therapy for OCD" und is marketed by Medtronic (Minneapolis, Minnesota). It has a HDE status by the FDA. The system consists of two quadripolar electrodes (Medtronic Reclaim DBS) as well as a generator (Medtronic Activa PC), which will be implanted into a subcutaneous pocket below the clavicula.

Первичные конечные точки

• Change of metabolic rates of glucose response pattern [Срок оценки: fPET measurements will take place in Week 4 and Week 5 of the trial.]

Вторичные конечные точки (3)

• Determination of association between metabolic (change in glucose consumption - PET), structural (white matter pathways - DTI) and functional connectivity (resting state fMRI - functional connectivity patterns) [Срок оценки: Data acquisition will take place during screening and in the first 5 weeks of the study.]
• Change in YBOCS scores by active DBS treatment and sham treatment [Срок оценки: Week 1 to 38]
• Correlation of metabolic (change in glucose consumption) and connectivity measures (white matter pathways) with clinical outcomes (YBOCS) and neuropsychological tests (SSRT, n-back, WCST) [Срок оценки: Data acquisition will take place during screening and in Week 1 to Week 38 of the study.]

Критерии участия

Критерии включения

• a score of 25 or higher on the Yale-Brown Obsessive Compulsive Scale
• previous failure to respond to at least two medication trials with serotonin reuptake inhibitors at or, if tolerated, beyond the FDA maximum recommended dose for a minimum duration over at least ten weeks each.
• at least one trial with tricyclic medication at or, if tolerated, beyond the FDA maximum recommended dose for a minimum duration over at least ten weeks each.
• at least one trial of augmentation with antipsychotic medication, lithium, a benzodiazepine or buspirone
• at least on trial of psychotherapy (cognitive behavioral therapy or comparable techniques) for at least 20 sessions
• ability to provide written informed consent

Критерии исключения

• any history of current or past psychotic disorder
• a manic episode within the preceding three years
• any current clinically significant medical or neurological disorder, that is a contraindication against DBS
• any disease that could lead to an altered glucose reactivity (e.g. diabetes)
• any clinically significant preoperative MRI abnormality or inability to undergo presurgical MRI
• current or unstable remitted substance abuse or dependence except nicotine
• pregnancy or high risk of becoming pregnant during study duration (desire to have children) and refusal to utilize a proper method of contraception
• Any current severe personality disorder except comorbid anankastic personality disorder
• Inability to follow the study protocol or adhere to operational requirements
• Current and unstable suicidality

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Австрия · 1 центр

• Medical University of Vienna, Department of Psychiatry and Psychotherapy — Vienna

Идентификаторы

NCT: NCT05577598 · V4 03062020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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