Cannabis and Parkinson's Disease Tremor: A Natural History Study

Parkinson's Disease Clinical Trial

Official title:

Cannabis and Parkinson's Disease Tremor: A Natural History Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028858
• Other study ID #: 13A-1339
• Status: Completed
• Phase: N/A
• First received: January 6, 2014
• Last updated: June 23, 2016
• Start date: November 2013
• Est. completion date: October 2015

Study information

• Verified date: June 2016
• Source: Bastyr University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This is a prospective, observational study designed to describe the effects of Cannabis on Parkinson's Disease tremor.

Description:

Ten individuals with Parkinson's disease (PD) and tremor who use Cannabis were observed for two weeks. Individuals were asked to keep a journal of Cannabis use (form, delivery method, amount) and wear an accelerometer on the wrist with the dominant tremor. Analyses will be performed to describe whether Cannabis use affects PD tremor following use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Parkinson's Disease

• Presence of PD-related tremor

• Currently using Cannabis for management of tremor

• Obtaining Cannabis in accordance with Washington State law

• Willing to log activities and experiences

• Willing to wear a motion sensor

• Able to attend 2 on-site visits

Exclusion Criteria:

• Presence of active infection within 5 days prior to enrollment

• Presence of unusual stressor within 5 days prior to enrollment

• Pregnancy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	Bastyr University	Kenmore	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bastyr University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in tremor as measured by Opal movement sensor		Upon enrollment, ongoing for 14 days	No