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Wearable Assessments in the Clinic and Home in PD | Clinical Trials | Clareo Health

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Wearable Assessments in the Clinic and Home in PD

A Multicenter, Prospective, Longitudinal, Digital Assessment Study of Disease Progression in Subjects with Early, Untreated Parkinson Disease

NCT03681015•University of Rochester

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate disease progression in persons with early Parkinson disease, as assessed by digital and electronic sensor data collection to be correlated with typical clinical assessments.

Detailed Description

Subjects will be evaluated via both in-clinic and at-home assessments. The in-clinic assessments are designed to compare the ability of current Parkinson disease clinical trial measures with the ability of mobile and wearable devices to detect disease progression in the early stage of disease. The at-home assessments are designed to determine the feasibility of motor and non-motor assessments of disease progression using a commercially available wearable device/mobile application platform and to determine how this data compares with traditional clinical measures.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Able to give written informed consent, as determined by the investigator.
•2. Subjects must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia as one of two symptoms); OR either asymmetric resting tremor or asymmetric bradykinesia.
•3. Screening dopamine transporter (DAT) SPECT scan is consistent with dopamine transporter deficit.
•4. A diagnosis of Parkinson disease for 2 years or less at screening.
•5. Modified Hoehn and Yahr stage \<=II at screening.
•6. Not expected to require PD medication for at least 6 months from baseline (includes dopaminergics, MAO-B inhibitors, and anti-cholinergics used to treat PD-related symptoms).
•7. Male or female age 30 years or older at time of PD diagnosis.
•8. Female subjects of childbearing potential must agree to be using highly effective contraception within 30 days prior to DaTscan (e.g., oral contraceptives, a barrier method of birth control (e.g., condoms with contraceptive foam, diaphragm with contraceptive jelly), intrauterine device, partner with vasectomy or sexual abstinence).
•9. Male subjects who are fertile and have a partner of childbearing potential must agree to use reliable contraception for 14 days following the administration of DaTscanTM (e.g., condoms with contraceptive foam or sexual abstinence).
•10. Fluent in English and able to read.
+7 more criteria

Exclusion Criteria

•1. A diagnosis of atypical parkinsonism, drug-induced parkinsonism, essential tremor, primary dystonia or other diagnoses that explain symptoms other than PD.
•2. History of PD-related freezing episodes or falls.
•3. A diagnosis of a significant CNS disease other than PD; history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child that would interfere with ability to perform study assessments.
•4. History of a brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality as determined by the investigator.
•5. Concomitant disease, condition, medication, or laboratory abnormality that, in the opinion of the investigator, could interfere with study conduct or analysis, or pose an unacceptable risk to the participant. This could include neurologic, orthopedic or cardiovascular diseases.
•6. Has taken levodopa, dopamine agonists, MAO B inhibitors, amantadine, anticholinergics or other medication for the treatment of PD or tremor within 60 days prior to baseline, or for more than a total of 60 days.
•7. Is taking medication for the treatment of tremor at the baseline visit. If taking medication for tremor at the screening visit, this medication must be stopped at least 14 days prior to baseline. If taking a tremor medication for another indication (e.g.
•hypertension, neuropathy), the medication can be continued during the study.
•8. For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (modafinil, bupropion, methylphenidate, neuroleptics, metoclopramide, alpha methyldopa, reserpine, or amphetamine derivative) must be willing and able from a medical standpoint to withhold the medication for at least 14 days prior to screening DaTscan imaging.
•9. Montreal Cognitive Assessment (MoCA) score \< 24 at screening.
+16 more criteria

Locations (17)

Banner Sun Research Institute

Sun City, Arizona, United States

University of California San Francisco

San Francisco, California, United States

University of Colorado Denver

Aurora, Colorado, United States

University of South Florida

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

Cleveland Clinic Nevada

Las Vegas, Nevada, United States

Northwell Health

Great Neck, New York, United States

NYU Langone Health

New York, New York, United States

University of Rochester

Rochester, New York, United States

Key Dates

Start Date

April 24, 2019

Primary Completion Date

February 21, 2022

Completion Date

March 30, 2022

Last Updated

October 8, 2024

Enrollment

132

ACTUAL participants

Conditions

Parkinson Disease

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Wearable Assessments in the Clinic and Home in PD

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations