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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; The subjects will be told they receive levodopa or acupuncture.	Behavioral: Levodopa or acupuncture; Comparison of subject expectancy of receiving levodopa or acupuncture.
Placebo Comparator: 2; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fatigue rate and muscle response evoked by transcranial muscle stimulation (TMS)	Before and immediately after the intervention

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Jou-Shin Lou, MD, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: June 4, 2008
• First Submitted That Met QC Criteria: June 4, 2008
• First Posted (Estimate): June 6, 2008

Study Record Updates

• Last Update Posted (Estimate): May 5, 2015
• Last Update Submitted That Met QC Criteria: May 4, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: fatigue; TMS; MEP
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Levodopa
• Other Study ID Numbers: U19AT002656-02 (U.S. NIH Grant/Contract); AT002656-02