Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's disease patients | Parkinson's disease patients receiving medical cannabis for pain related to the disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Cannabis | Drug | Patients will be assessed before and after use of Medical cannabis via inhaled dried buds or sublingual oil extract |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saar Anis, MD | Contact | +972 52 5691650 | saaranis@gmail.com | |
| Omer Anis, MD | Contact | +972 52 8787821 | omerwn@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Saar Anis, MD | Sheba Medical Center, Ramat-Gan, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Ramat Gan | 52621 | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D010300 | Parkinson Disease |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D064086 | Medical Marijuana |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |