A Study of Movement Disorders Using the QMAT At-Home Testing Device

This study is currently recruiting participants.
Verified June 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT01905839
First received: July 18, 2013
Last updated: April 16, 2014
Last verified: June 2013
  Purpose

Background:

- Parkinson s disease (PD) affects half a million Americans, causing slow movements, tremors, stiffness, and trouble walking. Currently, these symptoms are measured by physical exam, but this is unreliable and requires an office visit. Researchers want to study a different way to measure PD symptoms, using a home-testing machine called a QMAT device. It can test how quickly someone moves doing different tasks. Researchers will study how this testing compares to physical exam testing and whether the device can detect changes in PD symptoms over time.

Objectives:

- To see if a home testing device can be used to evaluate Parkinson s disease symptoms.

Eligibility:

- Adults at least 18 years old with PD.

Design:

  • Participants will have about 22 clinic visits over 5 years. Each visit will take up to 3 hours. Visits will be scheduled along with visits for another study.
  • At visit 1, participants will learn to use the QMAT device and how to send testing information to the clinic by computer. The device has a computer screen, some buttons, and some pegs. Participants will get a device to take home and any accessories.
  • Participants will learn 2 QMAT tests. For one, they will press keys as fast as possible. For the other, they will move pegs into holes. The tests will take a total of about 20 minutes.
  • Participants will take both tests at home, 2 times on the same day each week, once before their medication, once after.
  • A study coordinator will monitor the participant s computer data and discuss the at-home testing at the clinic visits.

Condition
Movement Disorders
Parkinson's Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Longitudinal Study Assessing the Pathophysiology of Movement Disorders Utilizing the QMAT at Home Testing Device

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Mean speed of keystrokes on a repetitive finger movement [ Time Frame: 5 years follow up ] [ Designated as safety issue: No ]
  • Mean speed of movement on a peg movement task [ Time Frame: 5 years follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA
  • Patients will have a diagnosis of Parkinson Disease
  • Age 18 or older
  • Able to give informed consent
  • Ability to comply by the schedule and routine of taking the at home tests with the QMAT system responsibly
  • ability to perform the QMAT testing
  • current or planned enrollment in 12-N-0137: A Phase 1 Open-label Dose Escalation Safety Study of Convection-Enhanced Delivery (CED) of Adeno-Associated Virus Encoding Glial Cell Line-Derived Neurotrophic Factor (AAV2-GDNF) in Subjects with Advanced Parkinson s Disease

EXCLUSION CRITERIA

  • Have more than 7 alcoholic drinks a week in the case of a woman or 14 alcoholic drinks a week in the case of a man.
  • Have had a brain tumor, a stroke, head trauma, epilepsy, or a history of seizures.
  • Have major depression or any major mental disorders (axis I disorders).
  • Have other neurologic disorder than a movement disorder
  • Have had a head injury where there was a loss of consciousness for more than a few seconds.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01905839

Contacts
Contact: Donovan P Stock (301) 594-3953 stockd@mail.nih.gov
Contact: Codrin I Lungu, M.D. (301) 402-0976 lunguci@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Codrin I Lungu, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT01905839     History of Changes
Other Study ID Numbers: 130167, 13-N-0167
Study First Received: July 18, 2013
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Rigidity
Assessment
Parkinson's Disease
Physiological Measures

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

ClinicalTrials.gov processed this record on April 17, 2014