Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Bladder over activity symptoms
研究概览
简要总结
Medical cannabis (MC) is a standard treatment in Israel to Parkinson's disease (PD) patients suffering from pain. Nevertheless, it is not known about MC effectiveness for other non-motor symptoms of the disease. Our aim is to prospectively observe patients with PD before and after initiation of MC, for non-motor symptoms effect. In specific, relying of data from multiple sclerosis patients and basic science showing cannabinoid receptor 1 (CB1) is abundantly expressed in the sub epithelial layer of the bladder, we will explore the impact of MC on bladder function and urinary symptoms.
详细描述
This is a prospective, open-label, observational study. Patients with Parkinson's disease (PD) receiving licensure from Israeli Ministry of Health (MOH) for using medical cannabis (MC) for PD related symptoms and pain, being followed up in the Movement Disorders Institute (MDI) at SHEBA Medical Center (SMC) will be eligible to participate. Assessment regarding patient demographic, disease characteristics (Hoehn and Yahr, disease duration, disease first symptom etc.) will be collected at baseline along with designated questionnaires to evaluate the non-motor symptoms (NMSS, PDSS, Kings PD pain scale, PDQ8) and urinary function (Bladder over activity, International prostate symptom score (IPSS) and nocturia questionnaires). after MC initiation, patients will be observed and evaluated for the impact of MC 4-8 weeks following treatment initiation. Also, for each patient, MC being used will be analyzed in order to expose relationship between phyto-cannabinoid content and efficacy or side effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease according to UK Parkinson's disease society barin bank clinical diagnostic criteria
- •Holds a validated Medical cannabis license, from Israeli Ministry of health
- •Able to sign informed consent
- •Age 18-80
排除标准
- •Use of Medical cannabis in the previous 30 days prior to study recruitment visit
- •Concomitent severe co-morbidities able to influence outcomes such as spinal injury, cancer, dementia.
- •Cannot sign informed consent
研究组 & 干预措施
Parkinson's disease patients
Parkinson's disease patients receiving medical cannabis for pain related to the disease
干预措施: Medical Cannabis (Drug)
结局指标
主要结局
Change in Bladder over activity symptoms
时间窗: before and 4-8 weeks after treatment initiation
Overactive Bladder Symptom Score (OABSS) questionnaires will be assessed before and after medical cannabis use, range 0-15, higher scores mean a worse outcome
Change in Non-motor symptoms scale (NMSS)
时间窗: before and 4-8 weeks after treatment initiation
NMSS will be assessed before and after medical cannabis use, range 0-360, higher scores mean a worse outcome
次要结局
- Change in subjective Pain(before and 4-8 weeks after treatment initiation)
- Change in Quality of life(before and 4-8 weeks after treatment initiation)
- Cannabis strand analysis(4-8 weeks following treatment initiation)
- Change in sleep quality(before and 4-8 weeks after treatment initiation)
- Change in International prostate symptom score (IPSS)(before and 4-8 weeks after treatment initiation)
研究者
Dr. Saar Anis
Principal investigator. Senior Neurologist, Movement Disorders Institute, Sheba Medical Center
Sheba Medical Center