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

NCT01905839 | Terminated

• 2 other identifiers: 13016713-N-0167
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Movement Disorders; Parkinson's Disease

Keywords

Rigidity; Assessment; Parkinson's Disease; Physiological Measures

Outcome Measures

Primary Outcomes (2)

• Mean speed of keystrokes on a repetitive finger movement

  5 years follow up

• Mean speed of movement on a peg movement task

  5 years follow up

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Adler CH, Hentz JG, Joyce JN, Beach T, Caviness JN. Motor impairment in normal aging, clinically possible Parkinson's disease, and clinically probable Parkinson's disease: longitudinal evaluation of a cohort of prospective brain donors. Parkinsonism Relat Disord. 2002 Dec;9(2):103-10. doi: 10.1016/s1353-8020(02)00012-3.

  PMID: 12473400 BACKGROUND

• Bronte-Stewart HM, Ding L, Alexander C, Zhou Y, Moore GP. Quantitative digitography (QDG): a sensitive measure of digital motor control in idiopathic Parkinson's disease. Mov Disord. 2000 Jan;15(1):36-47. doi: 10.1002/1531-8257(200001)15:13.0.co;2-m.

  PMID: 10634240 BACKGROUND

• Muller T, Benz S. Quantification of the dopaminergic response in Parkinson's disease. Parkinsonism Relat Disord. 2002 Jan;8(3):181-6. doi: 10.1016/s1353-8020(01)00010-4.

  PMID: 12039429 BACKGROUND

MeSH Terms

Conditions

Movement Disorders; Parkinson Disease; Muscle Rigidity

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Codrin I Lungu, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 23, 2013
• Study Start: June 18, 2013
• Primary Completion: April 15, 2015
• Study Completion: April 15, 2015
• Last Updated: September 25, 2018

Record last verified: 2015-04-15

Locations

US (1)