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

Sheba Medical Center

Status

Enrolling

Conditions

Bladder, Overactive

Parkinson Disease

Treatments

Drug: Medical Cannabis

Study type

Observational

Funder types

Other

Identifiers

NCT05106504

Sheba-20-7553-SA-CTL

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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