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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
  Purpose

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.


Condition Intervention
Parkinson's Disease
Behavioral: Levodopa or acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Expectation and Response to Levodopa & Acupuncture in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Fatigue rate and muscle response evoked by transcranial muscle stimulation (TMS) [ Time Frame: Before and immediately after the intervention ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: August 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
The subjects will receive levodopa (n/a for the acupuncture part of the study).
Behavioral: Levodopa or acupuncture
Comparison of subject expectancy of receiving levodopa or acupuncture.
Placebo Comparator: 2
The subjects are told they will receive levodopa or acupuncture.
Behavioral: Levodopa or acupuncture
Comparison of subject expectancy of receiving levodopa or acupuncture.
Experimental: 3
The subjects will be told they have 50% chance of receiving real or placebo/sham levodopa or acupuncture.
Behavioral: Levodopa or acupuncture
Comparison of subject expectancy of receiving levodopa or acupuncture.
No Intervention: 4
The subjects will be told they receive placebo/sham levodopa or acupuncture.
Behavioral: Levodopa or acupuncture
Comparison of subject expectancy of receiving levodopa or acupuncture.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00692328

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Jou-Shin Lou, MD, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Barry S. Oken, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00692328     History of Changes
Other Study ID Numbers: U19 AT002656-02, U19AT002656-02, AT002656-02
Study First Received: June 4, 2008
Last Updated: May 2, 2012
Health Authority: United States: Federal Government

Keywords provided by Oregon Health and Science University:
fatigue; TMS; MEP

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Levodopa
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014