Expectation and Response to Levodopa and Acupuncture in Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barry S. Oken, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00692328
First received: June 4, 2008
Last updated: May 2, 2012
Last verified: May 2012

June 4, 2008
May 2, 2012
August 2005
February 2007   (final data collection date for primary outcome measure)
Fatigue rate and muscle response evoked by transcranial muscle stimulation (TMS) [ Time Frame: Before and immediately after the intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00692328 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Expectation and Response to Levodopa and Acupuncture in Parkinson's Disease
Expectation and Response to Levodopa & Acupuncture in Parkinson's Disease

To investigate how levodopa and acupuncture affect fatigue and muscle function in people who suffer from Parkinson's disease. Subjects may choose to participate in levodopa or acupuncture part, or both. Study procedures include an exercise protocol, transcranial magnetic stimulation (a non-invasive type of brain stimulation that cause small muscle twitch), a blood draw, and personality surveys.

Subjects will answer surveys, have their blood drawn, undergo TMS and perform an exercise. The TMS/exercise task will measure fatigue and muscle response. The surveys will describe personality and measure fatigue. The CTRC will do genotype studies on the blood to look for genetic differences. Each subject is eligible to receive both study treatment types (levodopa and acupuncture). Depending upon the study treatment type they choose, each subject will be randomly assigned to one of six possible subject groups:

Ia. Full expectancy; levodopa: Subjects will be told that they are taking levodopa.

Ib. Half expectancy; levodopa: Subjects will be told that they have 50% chance of receiving levodopa or placebo.

Ic. No expectancy; levodopa: Subjects will be told that they are receiving placebo levodopa.

IIa. Full expectancy; acupuncture: Subjects will be told that they are receiving real acupuncture.

IIb. Half expectancy; acupuncture: Subjects will be told that they have 50% chance of receiving real or sham-acupuncture.

IIc. No expectancy; acupuncture: Subjects will be told that they are receiving sham-acupuncture.

Subjects will attend four visits for the levodopa part and/or three visits in the acupuncture part. On the first visit, subjects will answer questionnaires and have samples of their blood collected. On the other visits, subjects will undergo TMS while they perform a repetitive exercise task. Subjects will then either wait for 30 minutes or receive the investigative intervention that they have been randomly assigned for that particular visit, and then repeat the TMS/exercise task.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Parkinson's Disease
Behavioral: Levodopa or acupuncture
Comparison of subject expectancy of receiving levodopa or acupuncture.
  • Active Comparator: 1
    The subjects will receive levodopa (n/a for the acupuncture part of the study).
    Intervention: Behavioral: Levodopa or acupuncture
  • Placebo Comparator: 2
    The subjects are told they will receive levodopa or acupuncture.
    Intervention: Behavioral: Levodopa or acupuncture
  • Experimental: 3
    The subjects will be told they have 50% chance of receiving real or placebo/sham levodopa or acupuncture.
    Intervention: Behavioral: Levodopa or acupuncture
  • No Intervention: 4
    The subjects will be told they receive placebo/sham levodopa or acupuncture.
    Intervention: Behavioral: Levodopa or acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
February 2007
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's disease
  • Able to withdraw Parkinson's disease medication for 12 hours prior to a study visit
  • Must be currently using levodopa to qualify for the levodopa part of the study

Exclusion Criteria:

  • History of seizures
  • Presence of any metal in the body, including DBS stimulators, pacemakers, metal plates or pins
  • Severe cognitive deficits or psychosis
  • Evidence of any clinically unstable disease, such as cancer, HIV/AIDS; unstable heart condition or other conditions that might require hospitalization
  • Evidence of another neurological disease, such as multiple sclerosis, amyotrophic lateral sclerosis, or Huntington's disease
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00692328
U19 AT002656-02, U19AT002656-02, AT002656-02
Yes
Barry S. Oken, Oregon Health and Science University
Oregon Health and Science University
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Jou-Shin Lou, MD, PhD Oregon Health and Science University
Oregon Health and Science University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP