NCT05382858已完成不适用
Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Tremor-dominant Parkinson's Disease: a Prospective, Randomized, Double-blinded, Cross-over Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the tremor sub-score of the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III in the randomized phase
研究概览
简要总结
The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.
详细描述
This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating tremor-dominant PD. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Two months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 6 months post-implantation (at the end of the crossover phase), patients enter an open-label phase during which programming parameters are not restricted until the termination of the study at 12-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of idiopathic Parkinson's disease
- •tremor-dominant subtype in the on-medication condition
- •modified Hoehn-Yahr scale of 2 to 4 in the on-medication condition
- •receiving regular anti-parkinsonian drugs for more than 6 weeks
- •good compliance and written informed consent provided
排除标准
- •Atypical parkinsonism
- •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 that would increase 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
结局指标
主要结局
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the tremor sub-score of the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III in the randomized phase
时间窗: up to 6 months
in the off-medication condition
Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the tremor sub-score of the Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III in the randomized phase
时间窗: up to 6 months
in the off-medication condition
次要结局
- Change from baseline 39-item Parkinsons disease questionnaire to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Levodopa equivalent daily dose to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Levodopa equivalent daily dose to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline maximal phonatory time to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline maximal phonatory time to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline dysphonia severity index to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Mini-Mental Status Exam to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Beck depression inventory to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the MDS UPDRS-III in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Fahn-Tolosa-Marin Clinical Rating Scale in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Timed up and go test (TUG) in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Berg balance scale in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the levodopa equivalent daily dose in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the beck depression inventory in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the maximal phonatory time in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the dysphonia severity index in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Mini-Mental Status Exam in the randomized phase(up to 6 months)
- Change from baseline MDS UPDRS-III to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline MDS UPDRS-III to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Timed up and go test (TUG) to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Berg balance scale to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Berg balance scale to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline 39-item Parkinsons disease questionnaire to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline MDS UPDRS-III to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline MDS UPDRS-III to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Timed up and go test (TUG) to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Timed up and go test (TUG) to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Berg balance scale to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Berg balance scale to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline 39-item Parkinsons disease questionnaire to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline 39-item Parkinsons disease questionnaire to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Levodopa equivalent daily dose to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Levodopa equivalent daily dose to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline maximal phonatory time to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline maximal phonatory time to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline dysphonia severity index to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline dysphonia severity index to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Mini-Mental Status Exam to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Mini-Mental Status Exam to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Beck depression inventory to the end of PSA stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Change from baseline Beck depression inventory to the end of STN stimulation phase in the randomization phase(up to 6 months (4-6 months depending on randomization arm))
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the MDS UPDRS-III in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Fahn-Tolosa-Marin Clinical Rating Scale in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Timed up and go test (TUG) in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Berg balance scale in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the 39-item Parkinson's disease questionnaire in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the levodopa equivalent daily dose in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the beck depression inventory in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the maximal phonatory time in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the dysphonia severity index in the randomized phase(up to 6 months)
- Difference in improvement from baseline to the end of the PSA vs STN stimulation period in the Mini-Mental Status Exam in the randomized phase(up to 6 months)
- Adverse events(up to 12 months after surgery)
研究者
研究点 (1)
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