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

NCT00692328 | Completed DMC

• 2 other identifiers: U19AT002656-02AT002656-02
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

fatigue; TMS; MEP

Outcome Measures

Primary Outcomes (1)

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

  Before and immediately after the intervention

Study Arms (3)

1

ACTIVE COMPARATOR

The subjects will be told they receive levodopa or acupuncture.

Behavioral: Levodopa or acupuncture

2

PLACEBO COMPARATOR

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

Behavioral: Levodopa or acupuncture

3

EXPERIMENTAL

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

Behavioral: Levodopa or acupuncture

Interventions

Levodopa or acupuncture BEHAVIORAL

Comparison of subject expectancy of receiving levodopa or acupuncture.

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Fatigue

Interventions

Levodopa; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Complementary Therapies; Therapeutics

Study Officials

• Jou-Shin Lou, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: August 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

US (1)