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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Levodopa or acupuncture
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease focused on measuring fatigue; TMS; MEP

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

1

2

3

Arm Description

The subjects will be told they receive levodopa or acupuncture.

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

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

Outcomes

Primary Outcome Measures

Fatigue rate and muscle response evoked by transcranial muscle stimulation (TMS)

Secondary Outcome Measures

Full Information

First Posted
June 4, 2008
Last Updated
May 4, 2015
Sponsor
Oregon Health and Science University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00692328
Brief Title
Expectation and Response to Levodopa and Acupuncture in Parkinson's Disease
Official Title
Expectation and Response to Levodopa & Acupuncture in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
fatigue; TMS; MEP

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
The subjects will be told they receive levodopa or acupuncture.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
The subjects will be told they receive placebo/sham levodopa or acupuncture.
Arm Title
3
Arm Type
Experimental
Arm Description
The subjects will be told they have 50% chance of receiving real or placebo/sham levodopa or acupuncture.
Intervention Type
Behavioral
Intervention Name(s)
Levodopa or acupuncture
Intervention Description
Comparison of subject expectancy of receiving levodopa or acupuncture.
Primary Outcome Measure Information:
Title
Fatigue rate and muscle response evoked by transcranial muscle stimulation (TMS)
Time Frame
Before and immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jou-Shin Lou, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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

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