Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease

Conditions
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Bladder, Overactive, Parkinson Disease

Intervention / Treatment
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* Drug: Medical Cannabis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson's disease patients<br>Parkinson's disease patients receiving medical cannabis for pain related to the disease | Drug: Medical Cannabis<br>* Patients will be assessed before and after use of Medical cannabis via inhaled dried buds or sublingual oil extract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Non-motor symptoms scale (NMSS) | NMSS will be assessed before and after medical cannabis use, range 0-360, higher scores mean a worse outcome | before and 4-8 weeks after treatment initiation | 
| Change in Bladder over activity symptoms | Overactive Bladder Symptom Score (OABSS) questionnaires will be assessed before and after medical cannabis use, range 0-15, higher scores mean a worse outcome | before and 4-8 weeks after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep quality | PDSS questionnaire will be employed before and after MC use, range 0-28, higher scores mean a worse outcome | before and 4-8 weeks after treatment initiation | 
| Change in subjective Pain | Kings PD pain scale will be employed before and after MC use, range 0-168 , higher scores mean a worse outcome | before and 4-8 weeks after treatment initiation | 
| Change in Quality of life | PDQ8 questionnaire will be employed before and after MC use, range 0-32 , higher scores mean a worse outcome | before and 4-8 weeks after treatment initiation | 
| Cannabis strand analysis | Cannabinoid content within products being used by our patient will be analyzed. Correlation between efficacy and side effect profile to MC cannabinoid content will be employed | 4-8 weeks following treatment initiation | 
| Change in International prostate symptom score (IPSS) | IPSS will be assessed before and after medical cannabis use, range 0-35, higher scores mean a worse outcome | before and 4-8 weeks after treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-motor symptoms, Parkinson's disease, Bladder overactivity, Medical cannabis, Cannabidiol, delta-9-tetrahydrocannabinol, pain