Prospective Study to Compare the Impact on Motor, Neuropsychological, Psychiatric Outcomes and Quality of Life of STN-DBS Between Early Treated and Late-treated PD Patients.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- percentage of improvement in motor aspects
研究概览
简要总结
The aim of this study is to investigate the impact of DBS not only no motor outcomes, but also on neuropsychological and psychiatric aspects and on quality of life in young patients with a short history of disease.
详细描述
Bilateral STN DBS is a powerful treatment for advanced Parkinson disease with Levodopa induced motor complications. The beneficial effects of STN stimulation on motor disability and quality of life have been proved. However, the mean delay before neurosurgery is currently 14 years after diagnosis, when medical treatment no longer controls PD symptoms and quality of life is already severely impaired.
Aim of this study is to prospectively assess the effects of bilateral STN stimulation on motor signs, psychological and psychiatric aspects and quality of life in a group of 20 patients with PD who underwent surgery after 5 years from the onset of the disease. These results will be compared with those of a group of 20 patients with a PD history from more than 10 years.
The two groups of patients will be evaluated at baseline and after 3 and 12 months from DBS implant; at each visit neurological and motor examinations were assessed and dedicated neuropsychological and psychiatric tests will be performed.
Neurosurgery may be considered superior to medical treatment alone even in mild to moderate PD of 10 years duration, rather than a last resort in very advanced stages of the disease. Thanks to this study we could compare motor outcomes and cognitive aspects between DBS patients with a short and with long history of disease
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suffering from PD of > 10 years and with LTS (long term L-dopa syndrome), or with a duration of PD of 5 years
- •age< 70 years
- •normal brain MRI
- •absence of dementia (Mini Mental State Examination ≥ 24)
- •absence of severe psychiatric diseases
- •Signed informed consent form
- •Absence of allergy to metal
- •Italian native speaker
- •Absence of communicative or perceptive deficits
排除标准
- •Any form of familiar PD
- •Presence of neoplasia
- •Presence of HIV
- •Presence of severe metabolic diseases
- •Severe cardiac/respiratory/renal or hepatic diseases
- •Ongoing treatment with immunodepressive/ immunomodulate drugs
结局指标
主要结局
percentage of improvement in motor aspects
时间窗: after 12 months of stimulation
The primary objective of the study is calculates as: (UPDRS III 12 months - UPDRS III baseline)/UPDRS III baseline where UPDRS III 12 months means the score of this test in "medication off , stimulation on" condition at 12 months after implant, while UPDRS III baseline means the score of this test in "medication off " condition.
次要结局
- Neuropsychological aspects(after 3 and12 months of stimulation)
- Psychiatrical aspects(after 3 and12 months of stimulation)
- Quality of Life(after 3 and12 months of stimulation)
- Medication intake(after 3 and12 months of stimulation)