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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Patients will be assessed before and after use of Medical cannabis via inhaled dried buds or sublingual oil extract
Sheba Medical Center
Ramat Gan, Israel
RECRUITINGChange 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
Time frame: 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
Time frame: before and 4-8 weeks after treatment initiation
Change in sleep quality
PDSS questionnaire will be employed before and after MC use, range 0-28, higher scores mean a worse outcome
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: before and 4-8 weeks after treatment initiation
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