Acupuncture for Fatigue in Parkinson's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01360229
First received: May 23, 2011
Last updated: December 9, 2014
Last verified: December 2014
  Purpose

This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will receive either real or sham acupuncture twice weekly for six weeks.


Condition Intervention
Parkinsons Disease
Procedure: Acupuncture
Other: Acupuncture to treat fatigue in Parkinson disease

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture as a Symptomatic Treatment for Fatigue in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Modified Fatigue Impact Scale (MFIS) between treatment groups [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    The primary outcome measure will be the 6-week change in Modified Fatigue Impact Scale (MFIS) between treatment groups


Estimated Enrollment: 150
Study Start Date: August 2010
Estimated Study Completion Date: May 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Randomized Subjects receive a sham acupuncture.
Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
Other: Acupuncture to treat fatigue in Parkinson disease
Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.
Active Comparator: Randomized Subjects receive real acupuncture.
Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture.
Procedure: Acupuncture
Subjects will be randomized in a 1:1 ratio to receive real acupuncture. Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with PD
  • Patients 40-99 years of age
  • Patients who have significant fatigue
  • Patients must be on a stable medication regimen for the treatment of PD

Exclusion Criteria:

  • Patients who have had previous acupuncture within the past six months
  • Patients who have had deep brain stimulation (DBS)
  • Patients with dementia, depression, or sleep disorder
  • Patients who are currently taking medications known to affect fatigue, such as stimulants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360229

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Benzi Kluger, MD University of Colorado, Denver
  More Information

Additional Information:
No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01360229     History of Changes
Other Study ID Numbers: 10-0533
Study First Received: May 23, 2011
Last Updated: December 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Parkinsons Disease
Fatigue

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on April 19, 2015