Acupuncture for Fatigue in Parkinson's Disease
This study is currently recruiting participants.
Verified July 2011 by University of Colorado, Denver
Sponsor:
University of Colorado, Denver
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 19, 2012
Last verified: July 2011
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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. 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: | August 2015 |
| Estimated Primary Completion Date: | August 2015 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360229
Contacts
| Contact: Etta Abaca | 303-724-2193 | Etta.Abaca@ucdenver.edu |
Locations
| United States, Colorado | |
| University of Colorado Denver | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Benzi Kluger, MD, MS 303-724-2212 benzi.kluger@ucdenver.edu | |
| Contact: Karen Gronau karen.gronau@ucdenver.edu | |
| Principal Investigator: Benzi Kluger, MD, MS | |
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 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Colorado, Denver:
|
Parkinsons Disease Fatigue |
Additional relevant MeSH terms:
|
Fatigue Parkinson Disease Signs and Symptoms Parkinsonian Disorders Basal Ganglia Diseases |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 16, 2013