Ambulatory Parkinson's Disease Dyskinesia Monitor for Dru... | NCT02125825

Studies
Ambulatory Parkinson's Disease Dyskinesia Monitor for Drug Therapy Titration

NCT02125825

Sponsor

Great Lakes NeuroTechnologies Inc.

Status

Completed

Last Update Posted

Jan 12, 2016Estimated

Enrollment

14Actual

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

ID	Type	Description	Link
9R44AG044293	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 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

Jul 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Apr 25, 2014

First Submission Date that Met QC Criteria

Apr 25, 2014

First Posted Date

Apr 29, 2014Estimated

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

Jan 8, 2016

Last Update Posted Date

Jan 12, 2016Estimated

Name	Class
National Institute on Aging (NIA)	NIH
University of Rochester	OTHER
Johns Hopkins University	OTHER

Description Module

Brief Summary

The objective is to assess a compact, portable, wireless movement disorder system with continuous monitoring capabilities to detect and quantify the severity of levodopa-induced dyskinesia in Parkinson's disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parkinson's disease on levodopa		Individuals with Parkinson's disease who are taking levodopa to treat motor symptoms

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between motion sensor features and clinician-rated dyskinesia severity	Motor function (movement speed and magnitude measured with a motion sensor) will be collected for a period of 2 hours after taking normally prescribed dose of levodopa.	All data will be collected within a single session not to exceed 3 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of idiopathic Parkinson's disease
Clinical history of levodopa-induced dyskinesia
21 Years of age or older
Stage 2 - 4 OFF-medication on the Hoehn and Yahr scale

Exclusion Criteria:

Dementia (determined by a neuropsychological assessment)
Severe tremor unaffected by levodopa

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Individuals with Parkinson's disease and a history of levodopa-induced dyskinesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Medical Center		Baltimore	Maryland	21287	United States
University of Rochester Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided