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

NCT ID: NCT00692328

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2007-02-28

Brief 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.

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

1

The subjects will be told they receive levodopa or acupuncture.

Group Type: ACTIVE_COMPARATOR

Levodopa or acupuncture

Intervention Type: BEHAVIORAL

Comparison of subject expectancy of receiving levodopa or acupuncture.

2

The subjects will be told they receive placebo/sham levodopa or acupuncture.

Group Type: PLACEBO_COMPARATOR

Levodopa or acupuncture

Intervention Type: BEHAVIORAL

Comparison of subject expectancy of receiving levodopa or acupuncture.

3

The subjects will be told they have 50% chance of receiving real or placebo/sham levodopa or acupuncture.

Group Type: EXPERIMENTAL

Levodopa or acupuncture

Intervention Type: BEHAVIORAL

Comparison of subject expectancy of receiving levodopa or acupuncture.

Interventions

Levodopa or acupuncture

Comparison of subject expectancy of receiving levodopa or acupuncture.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Barry S. Oken

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jou-Shin Lou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

U19AT002656-02

Identifier Type: NIH

Identifier Source: secondary_id

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AT002656-02

Identifier Type: -

Identifier Source: secondary_id

U19AT002656-02

Identifier Type: NIH

Identifier Source: org_study_id

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