An observational study in Bladder, Overactive and Parkinson Disease, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-03.
Sponsored by Sheba Medical Center · Observational
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 100 is close to the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
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Current study population include PD patients, males and females, aged 18-80, with a license to use Medical cannabis for PD related symptoms, newly issued or, with no recent use.
Exclusion Criteria:
Parkinson's disease patients receiving medical cannabis for pain related to the disease
Drug: Medical Cannabis
Patients will be assessed before and after use of Medical cannabis via inhaled dried buds or sublingual oil extract
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
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
Plan to share: No
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This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center