Transplantation of Embryonic Dopamine Neurons for Treatment of Parkinson's Disease: Double-blind Placebo Surgery Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Global Rating Scale
研究概览
简要总结
A double-blind sham surgery-controlled trial was developed to determine the effectiveness of implantation of human embryonic dopamine neurons into the putamen of patients with advanced Parkinson's disease (PD), with half the patients receiving the implant (n = 20) and half receiving sham surgery (n = 20). The blind was maintained for 12 months before participants were told which surgery they received, at which time those receiving sham surgery could request the implant surgery.
详细描述
A double-blind sham surgery-controlled trial was conducted to determine the effectiveness of implantation of human embryonic dopamine neurons into the putamen of patients with advanced Parkinson's disease (PD), with half the patients receiving the implant (n = 20) and half receiving sham surgery (n = 20). The goals were to determine whether the cells survived and led to improvement of symptoms, and to examine the effect of age on results of the implantation. Quality of life of participants and care partners was also examined at each of the assessment periods (baseline, 4, 8 and 12 months). The blind was maintained for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All of the above were "masked." Only the neurosurgeon (Dr. Breeze) who did the implant and the person in charge of random assignment were aware of which participant received which treatment.
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Parkinson's disease (PD) for more than 7 years, improvement in response to levodopa, Positive Emission Tomography scan compatible with presence of PD, improvement of at least 33% on UPDRS after first morning dose of levodopa
排除标准
- •Mini-mental status exam score of less than 24, hallucinations during levodopa therapy, epilepsy, previous brain surgery, severe depression, another neurologic disorder, cardiovascular disease, and medical contraindication of surgery
研究组 & 干预措施
Neural implantation group
Human embryonic dopamine neurons were implanted into brains of half the randomized participants (n = 20). Participants were evaluated at baseline, 4, 8, and 12 months after surgery.
干预措施: Neural implantation group (Procedure)
Sham Surgery group
This group (n = 20) received sham surgery with a steel frame affixed to their heads and four burr holes drilled into their foreheads without crossing the blood/brain barrier. Participants were assessed at baseline, 4, 8, and 12 months after surgery.
干预措施: Sham surgery (Procedure)
结局指标
主要结局
Global Rating Scale
时间窗: Same scale was administered 7 days after surgery and prior to follow-up visits at Columbia at 4, 8, and 12 months after surgery and before the blind was lifted.
one item scale where participants marked their answer on a scale ranging from -3 (much worse since surgery) to 0 (no change) to +3 (much improved since surgery)
次要结局
未报告次要终点
研究者
Cynthia McRae, PhD
Research Professor
University of Denver