Movement Disorder Quantification Algorithm Development

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Great Lakes NeuroTechnologies Inc.
Sponsor:
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier:
NCT01534650
First received: February 14, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition
Parkinson's Disease
Essential Tremor

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Great Lakes NeuroTechnologies Inc.:

Primary Outcome Measures:
  • Processed kinematics [ Time Frame: During assessment ] [ Designated as safety issue: No ]
    Motion data collected during various motor tasks will be processed and compared to video review.


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534650

Contacts
Contact: Elizabeth Brokaw, Ph.D. 216-446-2453 ebrokaw@glneurotech.com

Locations
United States, Ohio
Great Lakes NeuroTechnologies Inc. Movement Disorders Laboratory Recruiting
Valley View, Ohio, United States, 44125
Principal Investigator: Dustin A Heldman, Ph.D.         
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
Investigators
Principal Investigator: Dustin A Heldman, PhD Great Lakes NeuroTechnologies Inc.
  More Information

No publications provided

Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT01534650     History of Changes
Other Study ID Numbers: GLNT-001
Study First Received: February 14, 2012
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Great Lakes NeuroTechnologies Inc.:
motion sensors
tremor
bradykinesia
gait
balance
dyskinesia

Additional relevant MeSH terms:
Essential Tremor
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 20, 2014