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

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ClinicalTrials.gov Identifier: NCT02028858
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
Bastyr University

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

Condition or disease
Parkinson's Disease

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.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cannabis and Parkinson's Disease Tremor: A Natural History Study
Study Start Date : November 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Percent reduction in tremor as measured by Opal movement sensor [ Time Frame: Upon enrollment, ongoing for 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinics; Washington State Parkinson's Disease Registry
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028858


Locations
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United States, Washington
Bastyr University
Kenmore, Washington, United States, 98028
Sponsors and Collaborators
Bastyr University
Investigators
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Principal Investigator: Laurie K Mischley, ND Bastyr University

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Responsible Party: Bastyr University
ClinicalTrials.gov Identifier: NCT02028858     History of Changes
Other Study ID Numbers: 13A-1339
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases