NCT01429207

Brief Summary

The purpose of the study is to test whether body-worn wireless motion sensors can measure dyskinesias (involuntary movements caused by medications) in individuals with Parkinson disease (PD) independent of voluntary activity being performed and other PD motor symptoms (e.g. tremor).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
Last Updated

June 29, 2012

Status Verified

June 1, 2012

First QC Date

September 2, 2011

Last Update Submit

June 28, 2012

Conditions

Parkinson's DiseaseDyskinesia

Keywords

levodopatremorbradykinesiamotion sensors

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Idiopathic PD demonstrating levodopa-induced dyskinesias

You may qualify if:

  • Clinical diagnosis of probable or definite idiopathic Parkinson Disease with motor fluctuations that include dyskinesias after taking their usual dose of levodopa/carbidopa

You may not qualify if:

  • Antipsychotic medications (including quetiapine and clozapine)
  • Coexisting neurologic disease such as stroke or dementia
  • Lacking capacity for informed consent
  • Residing in a nursing home
  • comorbid non-neurologic illnesses that impacts the ability to perform the study tasks
  • Implantable defibrillators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseDyskinesiasTremorHypokinesia

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2011

First Posted

September 7, 2011

Study Start

August 1, 2011

Last Updated

June 29, 2012

Record last verified: 2012-06

Locations

US(1)