Bladder, Overactive, Parkinson Disease
Conditions
Keywords
non-motor symptoms, Parkinson's disease, Bladder overactivity, Medical cannabis, Cannabidiol, delta-9-tetrahydrocannabinol, pain
Brief summary
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
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.
Interventions
DRUGMedical Cannabis
Patients will be assessed before and after use of Medical cannabis via inhaled dried buds or sublingual oil extract
Sponsors
Sheba Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Non-motor symptoms scale (NMSS) | 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 |
| Change in Bladder over activity symptoms | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of life | before and 4-8 weeks after treatment initiation | PDQ8 questionnaire will be employed before and after MC use, range 0-32 , higher scores mean a worse outcome |
| Change in sleep quality | before and 4-8 weeks after treatment initiation | PDSS questionnaire will be employed before and after MC use, range 0-28, higher scores mean a worse outcome |
| Change in International prostate symptom score (IPSS) | before and 4-8 weeks after treatment initiation | IPSS will be assessed before and after medical cannabis use, range 0-35, higher scores mean a worse outcome |
| Cannabis strand analysis | 4-8 weeks following treatment initiation | 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 |
| Change in subjective Pain | before and 4-8 weeks after treatment initiation | Kings PD pain scale will be employed before and after MC use, range 0-168 , higher scores mean a worse outcome |
Countries
Israel
Contacts
Primary ContactSaar Anis, MD
Backup ContactOmer Anis, MD
Outcome results
None listed