NCT06891781尚未招募不适用
A Prospective, Multi-center, Randomized, Double-blind, Cross Over, Clinical Trial to Compare the Safety and Effectiveness of Adaptive Versus Conventional Stimulation in Levodopa- Responsive Parkinson's Disease Treated with Bilateral Deep Brain Stimulation of the Subthalamic Nucleus
Newronika0 个研究点目标入组 72 人开始时间: 2025年6月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- Improvement in Good On Time (GOT)
研究概览
简要总结
The goal of this prospective, multi-center, randomized, double-blind, crossover clinical trial is to evaluate the effectiveness and safety of adaptive DBS (aDBS) and conventional DBS (cDBS) delivered through the AlphaDBS system, in levodopa-responsive Parkinson's disease subjects. Data from previous studies conducted in Europe indicate that the use of the AlphaDBS system is safe and effective in both aDBS and cDBS modes. However, such studies suggest that aDBS may lead to more ON-time without troublesome dyskinesias in some patients. The study is designed to first demonstrate safety of effectiveness of cDBS, then to directly compare effectiveness of aDBS relative to cDBS. Subjects enrolled in the study will undergo multiple visits to assess the improvement of PD symptoms and will be randomized to Mode 1 for three months, followed by Mode 2. At the end of Mode 2, subjects will select their preferred mode, which will be maintained for 3 additional months. Subjects will complete patient diaries at different time points to evaluate their symptoms throughout the day.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject who meet all of the following criteria may be given consideration for inclusion in this clinical trial:
- •Is willing and capable of signing informed consent
- •Is ≥18 years old
- •Has been diagnosed with levodopa-responsive idiopathic Parkinson's disease
- •Has a Hoehn and Yahr (H&Y) scale stage of II or III when OFF medication at screening
- •Exhibits motor fluctuations and PD-related symptoms that are not adequately controlled with medication, including motor complications of recent onset (>4 months duration)
- •Has been referred for bilateral STN DBS in accordance with local practice
- •Must be a good surgical candidate for placement of a deep brain stimulator as judged by the DBS surgical team
- •Montreal Cognitive Assessment score of ≥ 26 at the screening visit (when in "medON" state)
- •UPDRS-III improvement by ≥30% with the levodopa challenge test as measured at approximately 90 minutes following administration of the challenge dose
- •Successfully completed a 1-day test diary reaching a sufficient level of agreement (>75%) with study personnel responses and is willing and capable of completing a 5-day diary at each of the time points required per the protocol
- •If female, the subject is not currently pregnant (as determined by negative serum pregnancy test), breastfeeding, or is post-menopausal, surgically sterile or willing to use birth control for the duration of the study - acceptable forms of birth control are: hormone therapies (oral, injected, transdermal or implanted), IUD or other barrier methods (e.g., condom, diaphragm, cervical cap, spermicide/gel) or partner is surgically sterile
- •Is willing to maintain a constant anti-PD medication treatment (best medical management) for at least one month prior to DBS implantation
- •Is willing and able to attend all study-required visits, complete the study procedures and attend appropriate follow-up visits
排除标准
- •Has contraindications for DBS surgery, including any intracranial abnormality (e.g., generalized atrophy, vascular malformation, hydrocephalus, hematoma, cavernous or venous angioma, tumor or metastases, midline shift, etc.) or metallic implant (e.g., aneurysm clip, cochlear implant, etc.) or other clinically significant space-occupying lesion which in the opinion of the surgeon would impact the ability to target and place the leads or IPG
- •Is unable or unwilling to maintain a stable dose of levodopa anti-Parkinson's disease medication for 30 days prior to DBS surgery
- •Has any current major psychiatric disorder(s), such as Major Depressive Disorder, Bipolar I or II disorder, Schizophrenia, Schizoaffective Disorder, Delusional Disorder, Brief Psychotic Disorder, Obsessive-Compulsive Disorder, or any other current psychiatric condition that in the opinion of the investigator would confound the assessment of study endpoints, prevent proper data collection and/or compromise the subject's ability to participate, based on the psychiatric/psychological assessment at screening. It refers also to moderate or severe alcohol and/or substance use disorder based on the psychiatric/psychological assessment at screening. (It is permitted if a subject has a diagnosis of Major Depressive Disorder with symptoms that currently are well-controlled and managed by a stable regimen of antidepressants for a minimum of 4 weeks prior to the screening visit).
- •A history of suicide attempt within 3 years of the screening visit or current active suicidal ideation as determined by a psychiatric/ psychological evaluation
- •Any medical condition, such as cognitive impairment, dementia, seizures, congestive heart failure, unstable angina, uncontrolled diabetes, renal failure requiring dialysis, or any other severe medical condition that could interfere with study procedures, confound the assessment of study endpoints, prevent proper data collection, or that, in the opinion of the investigator, would compromise the subject's ability to participate
- •Confirmation of diagnosis of a terminal illness associated with survival <12 months
- •Needs repeated MRI scans
- •Requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
- •Has an electrical or electromagnetic implant (e.g., cochlear prosthesis, pacemaker, neurostimulator, etc.) or plans to obtain, an active implanted medical device (AIMD) and/or an implanted medication pump (e.g., DUOPA™ infusion pump) and/or is treated with a portable infusion pump for any indication
- •Is on anticoagulant therapy which cannot be paused for >5 days before surgery
- •A history of cranial surgery including ablation procedure or any other previous neurosurgical procedure for the treatment of PD symptoms on either side of the brain
- •Is currently participating in another clinical study (excluding any sub-study of the present trial).
结局指标
主要结局
Improvement in Good On Time (GOT)
时间窗: After 3 months of follow up in cDBS as compared with pre-op baseline
Mean improvement in GOT with conventional DBS (cDBS), when compared with pre-operative baseline
次要结局
- GOT difference between aDBS and cDBS(After 3 months of follow up in each mode)
- UPDRS III score difference between aDBS and cDBS(After 3 months of follow up in each mode)
- PDQ-39 score difference between aDBS and cDBS(After 3 months of follow up in each mode)
- Subject Preference for aDBS vs. cDBS(After 3 months of follow up in each mode)
- Comparison of Subject Preference for aDBS vs. cDBS based on PGI-I Ratings(After 3 months of follow up in cDBS as compared with pre-op baseline)
研究者
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