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

Phase

N/A

Condition

Substance Abuse

Treatment

N/A

Clinical Study ID

NCT05106504

Sheba-20-7553-SA-CTL

Ages 18-80
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Diagnosis of Parkinson's disease according to UK Parkinson's disease society barinbank clinical diagnostic criteria
Holds a validated Medical cannabis license, from Israeli Ministry of health
Able to sign informed consent
Age 18-80

Exclusion

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

Study Design

September 02, 2021

August 31, 2024

Study 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.

Connect with a study center

Sheba Medical Center
Ramat-Gan, 52621
Israel
Active - Recruiting

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