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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01360229
Date of registration: 23/05/2011
Prospective Registration: No
Primary sponsor: University of Colorado, Denver
Public title: Acupuncture for Fatigue in Parkinson's Disease
Scientific title: Acupuncture as a Symptomatic Treatment for Fatigue in Parkinson's Disease
Date of first enrolment: August 2010
Target sample size: 94
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01360229
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Benzi Kluger, MD
Address: 
Telephone:
Email:
Affiliation:  University of Colorado, Denver
Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 99 Years
Gender: All
Health Condition(s) or Problem(s) studied
Parkinsons Disease
Intervention(s)
Procedure: Acupuncture
Other: Acupuncture to treat fatigue in Parkinson disease
Primary Outcome(s)
Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups [Time Frame: 6 weeks]
Secondary Outcome(s)
Secondary ID(s)
10-0533
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Michael J. Fox Foundation for Parkinson's Research
Ethics review
Results
Results available: Yes
Date Posted: 12/08/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01360229
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