Asymmetric DBS for PD : A Multicenter, Prospective, Single Arm, Open Label Study

Официальное название

Asymmetric Deep Brain Stimulation for Parkinson's Disease: A Multicenter, Prospective, Single Arm, Open Label Study

Обзор

Deep brain stimulation (DBS) is an efficacious neurosurgical treatment for moderate-to-late stage Parkinson's disease (PD). The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two targets extensively studied and used worldwide in treating PD. Although the conventional SYMMETRIC bilateral STN and GPi DBS are shown to be effective in controlling motor symptoms such as bradykinesia, tremor, and dyskinesia, each target has its pros and cons in terms of axial symptom control, medication reduction, cognitive decline, and programming. Therefore, we speculate that an ASYMMETRIC bilateral implantation of DBS leads (i.e., combined unilateral STN and contralateral GPi DBS) may be able to bring the greatest clinical benefits to PD patients by taking advantage of both bilateral STN and GPi DBS at the same time. The preliminary retrospective study containing eight PD patients undergoing asymmetric implantation of DBS demonstrated the safety and efficacy of this treatment strategy during short-term follow-up. This multicenter, single arm, open label study aims to prospectively investigate during the long-term follow-up the safety and efficacy of asymmetric DBS for PD in terms of motor and nonmotor symptoms, medication reduction, cognitive decline, and quality of life.

Вмешательства

• Процедура Deep brain stimulation
  The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for moderate-to-advanced stage PD. The targets used in this study are STN and GPi, which are widely accepted and used for symptom control in PD. The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the movement disorder specialist.

Первичные конечные точки

• Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part III (MDS UPDRS-III) [Срок оценки: Followed for minimum of 7 years]

Вторичные конечные точки (12)

• Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part I, II, IV [Срок оценки: Followed for minimum of 7 years]
• Time-Up-Go (TUG) task [Срок оценки: Followed for minimum of 7 years]
• Berg Balance Scale, BBS [Срок оценки: Followed for minimum of 7 years]
• Gait and Falls Questionnaire, GFQ [Срок оценки: Followed for minimum of 7 years]
• Montreal Cognitive Assessment (MoCA) [Срок оценки: Followed for minimum of 7 years]
• Beck Depression Inventory, BDI [Срок оценки: Followed for minimum of 7 years]
• Beck Anxiety Inventory, BAI [Срок оценки: Followed for minimum of 7 years]
• Apathy Estimation Scale, AES [Срок оценки: Followed for minimum of 7 years]
• Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Current Full, QUIP-CF [Срок оценки: Followed for minimum of 7 years]
• Epworth Sleepiness Scale, ESS [Срок оценки: Followed for minimum of 7 years]
• Non-Motor Symptoms Scale, NMSS [Срок оценки: Followed for minimum of 7 years]
• Scales for Outcomes in PArkinson's disease - Autonomic, SCOPA-AUT [Срок оценки: Followed for minimum of 7 years]

Критерии участия

Критерии включения

• Diagnosed with idiopathic Parkinson's disease based on the MDS clinical diagnostic criteria for Parkinson's disease
• Aged more than 18 years
• Levodopa challenge test indicating a preoperative levodopa responsiveness over 24% based on MDS UPDRS-III
• the modified Hoehn-Yahr Scale between 2 and 4 under on-medication condition
• Compliance with written informed consent

Критерии исключения

• Atypical parkinsonian syndrome
• History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
• Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
• Presence of anatomical abnormalities in the target region
• Clinically significant medical history or that increases pre-/post-operative complications
• Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT04616521 · Ruijin_ADP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗