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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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 23, 2014
Last verified: March 2014
  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)
  Hide Detailed Description

Detailed Description:

Objectives

The purpose of this protocol is to improve the understanding of the pathophysiology of movement disorders and to assess movement in Parkinson s disease by performing small behavioral exercises and objectively measuring movements utilizing the QMAT at home testing device. These devices will be provided by the Kinetics Foundation. We have developed a series of motor tasks that can be performed with the QMAT, a home-based computer module, so that data on patient s movement can be collected frequently and prospectively without obligating the patient to come to a medical center. The study is designed to be observational in nature.

The QMAT device is being implemented to respond to the interest in objectified tests to monitor, analyze, and further understand the physiological aspects of Parkinson s disease. We will conduct:

  • Training to patients to perform tasks on the QMAT device and transmit data at home.
  • Training to investigators who do not have prior experience using the system
  • Testing using the QMAT device that may increase knowledge of a disease process, responsiveness of treatment or be helpful in patient progress evaluations by analyzing data collected from the at home tests.

This protocol includes only non-invasive techniques with minimal risk to the participants. The technique has been piloted as part of the 10-N-0009 protocol, Physiological Investigations in Movement Disorders.

Study Population

We intend to study patients with diagnosis of Parkinson Disease.

We will enroll up to 60 participants in order to obtain 48 patients who complete the study.

Design

We will assign and train study participants to use the QMAT device at home. This is a portable device with a simple keyboard and pegboard interface, storing data from patient performance at home. There are 2 tasks that are performed using the device. The pegboard task involves transferring pegs from holes on one side of the device to the opposite side of the device. The finger tapping test and the digitography tasks involve having the subject press keys on the keyboard. At enrollment into this study, a time schedule will be discussed with the participant regarding the schedule that these at home tests require to be conducted. We will provide the device, all the components, and a data storage thumb-drive to each participant.

Outcome measures

i. Bradykinesia (fine motor movements):

The component of the apparatus that will test fine motor control will involve finger pads that will be tapped in alternating fashion by the patient for 30 seconds.

The primary outcome variable will be mean keystroke velocity (completed alternating cycles/testing period, expressed as cm/sec. Secondary outcomes will be mean frequency expressed as Hz, mean strike duration, expressed as m/sec and temporal variation of the duration of finger strike and frequency (issues of fatigue) expressed as the coefficient of variation (SD/mean). Variation in velocity will be expressed as the SD.

ii. Complex movements: (Pegboard or plugging device):

The At-Home device also contains plugging tasks. Primary outcome: mean movement velocity expressed as seconds per plugging cycle. This measure can be analyzed statistically for all movements to correct for outlier responses and errors. A secondary outcome will also be defatigation (i.e., the linear change of speed during a testing session, expressed as percent of the cycle-time. The variance of speed will be provided by the standard deviation. A regression analysis will allow estimates of the part of the variance that is declared by linear change over the complete task.

  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
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: 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 23, 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:
Disease
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014