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

June 23, 2016 updated by: Bastyr University
This is a prospective, observational study designed to describe the effects of Cannabis on Parkinson's Disease tremor.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Kenmore, Washington, United States, 98028
        • Bastyr University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinics; Washington State Parkinson's Disease Registry

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent reduction in tremor as measured by Opal movement sensor
Time Frame: Upon enrollment, ongoing for 14 days
Upon enrollment, ongoing for 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bastyr University

Investigators

  • Principal Investigator: Laurie K Mischley, ND, Bastyr University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Estimate)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 23, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13A-1339

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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