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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00692328
Study type	Interventional
Source	Oregon Health and Science University
Contact
Status	Completed
Phase	N/A
Start date	August 2005
Completion date	February 2007

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms