Parkinson's DiseaseNCT00692328
Expectation and Response to Levodopa and Acupuncture in Parkinson's Disease
A study testing Levodopa or acupuncture in people with Parkinson's Disease, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Levodopa or acupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Feb 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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.
Read the 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
- Being tested
- Levodopa or acupuncture
- Keywords
- fatigue; TMS; MEP
- Medical subject headings
- Parkinson Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa or acupunctureBehavioural
Comparison of subject expectancy of receiving levodopa or acupuncture.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The subjects will be told they receive levodopa or acupuncture. Receives: Behavioral: Levodopa or acupuncture |
| 2 | Placebo comparator | The subjects will be told they receive placebo/sham levodopa or acupuncture. Receives: Behavioral: Levodopa or acupuncture |
| 3 | Experimental | The subjects will be told they have 50% chance of receiving real or placebo/sham levodopa or acupuncture. Receives: Behavioral: Levodopa or acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue rate and muscle response evoked by transcranial muscle stimulation (TMS)
Measured: Before and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startAug 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Barry S. Oken, Oregon Health and Science University
- Investigators
- Jou-Shin Lou, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692328
- Sponsor's protocol ID
- U19AT002656-02
- Other IDs
- U19AT002656-02, AT002656-02
- Status last verified
- May 2015
- First submitted
- 4 Jun 2008
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expectation and Response to Levodopa & Acupuncture in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00692328
- Acronym / sponsor ID
- U19AT002656-02
- Conditions
- Parkinson's Disease
- Keywords
- fatigue; TMS; MEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Levodopa or acupunctureThe subjects will be told they receive levodopa or acupuncture. |
| 2 | Placebo comparator | Behavioral: Levodopa or acupunctureThe subjects will be told they receive placebo/sham levodopa or acupuncture. |
| 3 | Experimental | Behavioral: Levodopa or acupunctureThe subjects will be told they have 50% chance of receiving real or placebo/sham levodopa or acupuncture. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levodopa or acupunctureComparison of subject expectancy of receiving levodopa or acupuncture. | Behavioural | 1, 2, 3 |
Primary outcome
Fatigue rate and muscle response evoked by transcranial muscle stimulation (TMS)
Time frame: Before and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jou-Shin Lou, MD, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levodopa or acupuncture in people with Parkinson's Disease, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue rate and muscle response evoked by transcranial muscle stimulation (TMS) (time frame: Before and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.