NCT01534650

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 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

February 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

3.9 years

First QC Date

February 14, 2012

Last Update Submit

February 22, 2017

Conditions

Parkinson's DiseaseEssential Tremor

Keywords

motion sensorstremorbradykinesiagaitbalancedyskinesia

Outcome Measures

Primary Outcomes (1)

  • Processed kinematics

    Motion data collected during various motor tasks will be processed and compared to video review.

    During assessment

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Lakes NeuroTechnologies Inc. Movement Disorders Laboratory

Valley View, Ohio, 44125, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseEssential TremorTremorHypokinesiaDyskinesias

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dustin A Heldman, PhD

    Great Lakes NeuroTechnologies Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2012

First Posted

February 17, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(1)