Parkinson's DiseaseNCT00912977
Prospective Evaluation of Forceplate Measured Levodopa-Induced Dyskinesia
An observational study of Parkinson's Disease, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias; LID) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2010
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinsons disease patients with levodopa-induced dyskinesia
Who may be able to join
- Parkinsons disease
- Older than 18
Who cannot join
- Must be participating in a Parkinsons disease study at Oregon Health \& Science University
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97201
About this study
Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias; LID) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. The purpose of this study is to demonstrate the validity and reliability of objectively measuring dyskinesia with a forceplate.
Read the detailed description
The main outcome measure of this study are measurements taken every half hour during an inpatient study visit. These measurements include standing on a forceplate for 1 minute while performing a mental task such as reciting the alphabet backwards. During this forceplate stance, a rater will visually score your movements. All participants must be eligible for another Parkinson's disease study at Oregon Health and Science University.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinsons disease, dyskinesia, measurement
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Groups are defined by another study | |
| Group 2 | Groups are defined by another study | |
| Group 3 | Groups are defined by another study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forceplate Measure
Measured: Every 1/2 hour
Secondary outcomes (1)
Visual Rating Scale
Measured: every 1/2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Anne Chung, Oregon Health and Science University
- Investigators
- Kathryn Chung, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912977
- Sponsor's protocol ID
- e5348
- Status last verified
- Sep 2016
- First submitted
- 2 Jun 2009
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Durif F, Debilly B, Galitzky M, Morand D, Viallet F, Borg M, Thobois S, Broussolle E, Rascol O. Clozapine improves dyskinesias in Parkinson disease: a double-blind, placebo-controlled study. Neurology. 2004 Feb 10;62(3):381-8. doi: 10.1212/01.wnl.0000110317.52453.6c.
PubMed 14872017Hagell P, Widner H. Clinical rating of dyskinesias in Parkinson's disease: use and reliability of a new rating scale. Mov Disord. 1999 May;14(3):448-55. doi: 10.1002/1531-8257(199905)14:33.0.co;2-0.
PubMed 10348468Durif F, Vidailhet M, Debilly B, Agid Y. Worsening of levodopa-induced dyskinesias by motor and mental tasks. Mov Disord. 1999 Mar;14(2):242-5. doi: 10.1002/1531-8257(199903)14:23.0.co;2-w.
PubMed 10091616
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Forceplate Measured Levodopa-Induced Dyskinesia
- ClinicalTrials.gov ID
- NCT00912977
- Acronym / sponsor ID
- e5348
- Conditions
- Parkinson's Disease
- Keywords
- Parkinsons disease, dyskinesia, measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Jun 2009 (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.
Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias; LID) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. The purpose of this study is to demonstrate the validity and reliability of objectively measuring dyskinesia with a forceplate.
Detailed description
The main outcome measure of this study are measurements taken every half hour during an inpatient study visit. These measurements include standing on a forceplate for 1 minute while performing a mental task such as reciting the alphabet backwards. During this forceplate stance, a rater will visually score your movements. All participants must be eligible for another Parkinson's disease study at Oregon Health and Science University.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Groups are defined by another study |
| Group 2 | – | –Groups are defined by another study |
| Group 3 | – | –Groups are defined by another study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinsons disease patients with levodopa-induced dyskinesia
Key inclusion criteria (2 listed)
- Parkinsons disease
- Older than 18
Key exclusion criteria (1 listed)
- Must be participating in a Parkinsons disease study at Oregon Health \& Science University
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Forceplate Measure
Time frame: Every 1/2 hour
1 secondary outcome
Visual Rating Scale
Time frame: every 1/2 hour
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 30 Sep 2016.
- Background: PubMed 14872017Durif F, Debilly B, Galitzky M, Morand D, Viallet F, Borg M, Thobois S, Broussolle E, Rascol O. Clozapine improves dyskinesias in Parkinson disease: a double-blind, placebo-controlled study. Neurology. 2004 Feb 10;62(3):381-8. doi: 10.1212/01.wnl.0000110317.52453.6c.
- Background: PubMed 10348468Hagell P, Widner H. Clinical rating of dyskinesias in Parkinson's disease: use and reliability of a new rating scale. Mov Disord. 1999 May;14(3):448-55. doi: 10.1002/1531-8257(199905)14:33.0.co;2-0.
- Background: PubMed 10091616Durif F, Vidailhet M, Debilly B, Agid Y. Worsening of levodopa-induced dyskinesias by motor and mental tasks. Mov Disord. 1999 Mar;14(2):242-5. doi: 10.1002/1531-8257(199903)14:23.0.co;2-w.
- Individual participant dataSharing planned: Undecided
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
Kathryn Chung, MD 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?
An observational study of 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 2 inclusion and 1 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 30 Sep 2016. 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. 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?
Forceplate Measure (time frame: Every 1/2 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00912977, which also lists 3 linked publications.
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 30 Sep 2016.