Prospective Evaluation of Forceplate Measured Levodopa-In... | NCT00912977

Studies
Prospective Evaluation of Forceplate Measured Levodopa-Induced Dyskinesia

NCT00912977

Sponsor

Oregon Health and Science University

Status

Completed

Last Update Posted

Sep 30, 2016Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Parkinson's Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jun 2, 2009

First Submission Date that Met QC Criteria

Jun 2, 2009

First Posted Date

Jun 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2016

Last Update Posted Date

Sep 30, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kathryn Anne Chung, Associate Professor, Oregon Health and Science UniversityPrincipal Investigator

Lead Sponsor

Oregon Health and Science UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Groups are defined by another study
Group 2		Groups are defined by another study
Group 3		Groups are defined by another study

Interventions

Not provided

Measure	Description	Time Frame
Forceplate Measure		Every 1/2 hour

Measure	Description	Time Frame
Visual Rating Scale		every 1/2 hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parkinsons disease
Older than 18

Exclusion Criteria:

Must be participating in a Parkinsons disease study at Oregon Health & Science University

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Parkinsons disease patients with levodopa-induced dyskinesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathryn Chung, MD	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health & Science University		Portland	Oregon	97201	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14872017	Background	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.
10348468	Background	Hagell 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.

ID	Term
D010300	Parkinson Disease
D020820	Dyskinesias

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases