Expectation and Response to Levodopa and Acupuncture in Parkinson's Disease
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Parkinson's Disease |
Behavioral: Levodopa or acupuncture |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Expectation and Response to Levodopa & Acupuncture in Parkinson's Disease |
- Fatigue rate and muscle response evoked by transcranial muscle stimulation (TMS) [ Time Frame: Before and immediately after the intervention ] [ Designated as safety issue: No ]
| Enrollment: | 63 |
| Study Start Date: | August 2005 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
The subjects will receive levodopa (n/a for the acupuncture part of the study).
|
Behavioral: Levodopa or acupuncture
Comparison of subject expectancy of receiving levodopa or acupuncture.
|
|
Placebo Comparator: 2
The subjects are told they will receive 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.
|
|
No Intervention: 4
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | Jou-Shin Lou, MD, PhD | Oregon Health and Science University |
More Information
No publications provided
| Responsible Party: | Barry S. Oken, MD, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00692328 History of Changes |
| Other Study ID Numbers: | U19 AT002656-02, U19AT002656-02, AT002656-02 |
| Study First Received: | June 4, 2008 |
| Last Updated: | May 2, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Oregon Health and Science University:
|
fatigue; TMS; MEP |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Levodopa |
Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013