Bilateral Subthalamic Stimulation in PD Patients With Impulse Control Disorders - STIMPulseControl

Официальное название

A Randomized Controlled Trial of Bilateral Subthalamic Stimulation in Patients With Parkinson's Disease and Impulse Control Disorders

Обзор

The focus of the study is on patients Parkinson's disease showing as well behavioral disorders that can be described as pathological and are summarized under the term impulse control disorder (ICD). Changes in behavior and also pathological disorders are a common side effect of treatment for Parkinson's disease. The goal of this academic study is to compare the effect of surgical (deep brain stimulation, DBS) treatment combined with a coordinated and adapted best medical treatment (BMT) to be compared with the effect of optimized best medical treatment (BMT) alone. The stimulation arm (DBS+BMT) as well as the medication arm (BMT only) will be monitored according to clinical routine. Participants will have to agree to be randomly assigned to either deep brain stimulation in combination with the best medical treatment (DBS group) or the best medical treatment alone (BMT group). Participants will have to come regularly according to clinical routine to the clinic and complete various questionaires and scales for the study.

Вмешательства

• Процедура bilateral high frequency deep brainstimulation of the subthalamic nucleus combined with best medical treatment
  according to widely accepted expert consensus paper
• Препарат best medical treatment (BMT): Adjustment of the dopaminergic medication and non-dopaminergic therapy customized for each patient according to the latest published Consensus Group Recommendations
  according to (Debove et al (2024), 'Management of Impulse Control and Related Disorders in Parkinson's Disease: An Expert Consensus, Mov Disord.

Первичные конечные точки

• Ardouin Scale of Behaviour in Parkinson's Disease (ASBPD) [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Questionnaire for Impulsive-Compulsive Disorders in Parkinson Disease Rating Scale (QUIP RS) [Срок оценки: 12 months]
• Starkstein-Apathy-Scale (SAS) [Срок оценки: 12 months]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 12 months]
• Beck Depression Inventory (BDI) [Срок оценки: 12 months]
• suicidal item 9 of the BDI [Срок оценки: 12 months]
• Neuropsychiatric-fluctuations scale (NFS) [Срок оценки: 12 months]
• Young mania rating scale (YMRS) [Срок оценки: 12 months]
• Quality of life (PDQ-39) measured by Parkinson Disease Questionaire-39 Summary Index [Срок оценки: 12 months]
• Zarit Burden Interview ( ZIB) for the change of burden assessment in caregivers using the brief version [Срок оценки: 12 months]
• MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (parts I-IV med on/med off and stim on/stim off; if applicable [Срок оценки: 12 months]
• Marconi Dyskinesia Rating Scale [Срок оценки: 12 months]
• Levodopa-equivalent/dopamine-agonist dosage (LEDD) and other medication [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Age at the time of enrollment: ≤ 70 years
• Diagnosis of PD according to MDS clinical diagnostic criteria
• Onset of first PD motor symptoms ≥ 4 years
• Moderate or severe impulse control disorder or related behavioral disorders according to Ardouin, with at least 1 score greater than or equal to 3 (or at least 2 scores greater than or equal to 2) on the Ardouin behaviour scale with the following items considered to reflect ICBDs or related behaviors: pathological gambling, hypersexuality, shopping, eating, hobbyism, punding and compulsive medication use
• MDS-UPDRS III improvement of ≥ 30% in the standardized levodopa test or classical Parkinsonian tremor at rest
• Adaptation of medical therapy has been attempted
• MoCA ≥ 24 in the meds on condition
• BDI-II score < 20 in the meds on condition, or Patients with moderately severe depression with a BDI-II between 20 and 28 points, strict consideration must be made with the involvement of a psychiatrist. Patients must be willing and able to comply this.
• Patients able to understand the study requirements and the treatment procedures
• Written informed consent before any study-specific tests or procedures are performed

Критерии исключения

• Surgical contraindications to undergo DBS operation
• Ongoing severe depression (BDI-II > 28)
• suicidal ideation (item 9 of BDI-II > 1)
• Dementia (MoCA < 24) in the meds on condition
• Any prior movement disorder treatments that involved intracranial surgery/ablation or intracranial device implantation
• Any other active implanted device that is likely to interfere with the implantation or functioning of the DBS system
• Simultaneous participation in another clinical trial targeting or potentially interfering with ICD
• Any history of recurrent seizures or haemorrhagic stroke
• Fertile women not using adequate contraceptive methods
• Any terminal illness with significantly reduced life expectancy which exclude DBS implantation according to standard clinical care
• A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
• Any impairment that would limit subject's ability to participate in the study and perform study procedures
• Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints

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

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Германия · 9 центров

• University Hospital Cologne — Cologne
• University Hospital Carl Gustav Carus — Dresden
• University Hospital Duesseldorf — Düsseldorf
• University Medical Center Hamburg-Eppendorf — Hamburg
• University Hospital Schleswig-Holstein (UKSH), Campus Kiel — Kiel
• University Hospital of Giessen and Marburg (UKGM), Campus Marburg — Marburg
• Charité Campus Mitte — Mitte
• University Hospital Tuebingen — Tübingen
• … и ещё 1 центр

Швейцария · 2 центра

• University Hospital of Bern (Inselspital) — Bern
• University Hospital Zuerich (USZ) — Zurich

Нидерланды · 1 центр

• Amsterdam University Medical Center — Amsterdam

Идентификаторы

NCT: NCT06498349 · KKS-313

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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