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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01905839
Recruitment Status : Terminated
First Posted : July 23, 2013
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Movement Disorders Parkinson's Disease

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 3 participants
Time Perspective: Prospective
Official Title: A Longitudinal Study Assessing the Pathophysiology of Movement Disorders Utilizing the QMAT at Home Testing Device
Study Start Date : June 18, 2013
Primary Completion Date : April 15, 2015
Study Completion Date : April 15, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Mean speed of keystrokes on a repetitive finger movement [ Time Frame: 5 years follow up ]
  2. Mean speed of movement on a peg movement task [ Time Frame: 5 years follow up ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905839


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Codrin I Lungu, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
More Information

Publications:
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT01905839     History of Changes
Other Study ID Numbers: 130167
13-N-0167
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: April 15, 2015

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Rigidity
Assessment
Parkinson's Disease
Physiological Measures

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