Movement Disorder Quantification Algorithm Development | NCT01534650

Studies
Movement Disorder Quantification Algorithm Development

NCT01534650

Sponsor

Great Lakes NeuroTechnologies Inc.

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

17Actual

Phase

Not provided

Conditions

Parkinson's Disease
Essential Tremor

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

Feb 2017

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

Feb 2012

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Feb 14, 2012

First Submission Date that Met QC Criteria

Feb 14, 2012

First Posted Date

Feb 17, 2012Estimated

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

Feb 22, 2017

Last Update Posted Date

Feb 23, 2017Actual

Description Module

Brief Summary

The purpose of this study is to collect kinematic motion data from subjects with movement disorders such as Parkinson's disease (PD) and essential tremor (ET) to develop and validate algorithms for quantifying motor symptoms such as tremor, bradykinesia (slowed movements), dyskinesias (sudden, involuntary movements), gait, and balance during standardized tasks and/or activities of daily living.

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

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

17Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Processed kinematics	Motion data collected during various motor tasks will be processed and compared to video review.	During assessment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 years or older
Clinical diagnosis of idiopathic Parkinson's disease or essential tremor
Able to provide informed consent

Exclusion Criteria:

Significant medical or psychiatric illness
Not capable of following the required clinical instructions
Serious medical conditions that compromise safety

Accepts Healthy Volunteers

Yes

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

Residents of Northeastern Ohio with a movement disorder such as Parkinson's disease or essential tremor.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dustin A Heldman, PhD	Great Lakes NeuroTechnologies Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Great Lakes NeuroTechnologies Inc. Movement Disorders Laboratory		Valley View	Ohio	44125	United States

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D020329	Essential Tremor
D014202	Tremor
D018476	Hypokinesia
D020820	Dyskinesias

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