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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692328
• Other study ID #: U19AT002656-02
• Secondary ID: U19AT002656-02AT
• Status: Completed
• Phase: N/A
• First received: June 4, 2008
• Last updated: May 4, 2015
• Start date: August 2005
• Est. completion date: February 2007

Study information

• Verified date: May 2015
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Levodopa or acupuncture
Comparison of subject expectancy of receiving levodopa or acupuncture.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue rate and muscle response evoked by transcranial muscle stimulation (TMS)		Before and immediately after the intervention	No