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Wearable Assessments in the Clinic and Home in PD (WATCH-PD)

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ClinicalTrials.gov Identifier: NCT03681015
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Ray Dorsey, University of Rochester

Brief 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.

Condition or disease
Parkinson Disease

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter, Prospective, Longitudinal, Digital Assessment Study of Disease Progression in Subjects With Early, Untreated Parkinson Disease
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : August 15, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change and variability in inertial sensor-derived measures of motor function from baseline to 12 months during performance of the MDS-UPDRS part 3 motor exam. [ Time Frame: 12 months ]
    Features will be extracted from continuous accelerometer and gyroscope signals, obtained via a set of body-worn inertial sensors, during performance of the MDS-UPDRS part 3, and the change and variability of these features will be assessed.

  2. Correlations between inertial sensor-derived measures of motor function and clinician ratings during performance of the MDS-UPDRS part 3 and total exam at baseline, 1, 3, 6, 9, and 12 months. [ Time Frame: 12 months ]
    Features extracted from continuous accelerometer and gyroscope signals recorded during each relevant component of the UPDRS part 3 will be correlated with corresponding clinician ratings to quantify the relationship between these measures.


Secondary Outcome Measures :
  1. Correlations between sensor-derived measures of motor function (accelerometer, gyroscope) and patient-reported outcomes measured by MDS-UPDRS parts 1b and 2 at baseline, 1, 3, 6, 9, and 12 months. [ Time Frame: 12 months ]
    Features extracted from continuous accelerometer and gyroscope signals, recorded during the UPDRS part 3 will be correlated with scores on the UPDRS 1b and 2 subtests to examine how sensor-derived measures relate to patient reported activities of daily living and quality of life.

  2. Correlations between sensor-derived measures of motor function (accelerometer, gyroscope) and patient-reported outcomes measured by PDQ-8 at baseline, 1, 3, 6, 9, and 12 months. [ Time Frame: 12 months ]
    Features extracted from continuous accelerometer and gyroscope signals, recorded during the UPDRS part 3 will be correlated with scores on the PDQ-8 to examine how sensor-derived measures relate to patient reported quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects with early, untreated Parkinson disease, aged 30 years or older at time of disease diagnosis
Criteria

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 I or 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.
  11. Able to perform all study activities (including walking tasks and timed up and go)

10. Willingness and ability to comply with study requirements.

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. 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.
  8. Montreal Cognitive Assessment (MoCA) score < 26 at baseline.
  9. Is pregnant (or is planning to become pregnant during the study period) or lactating (includes a negative urine (or serum if required by site) pregnancy test on day of screening scan prior to injection of DaTscanTM
  10. Known hypersensitivity to DaTscanTM or any of its excipients
  11. Body habitus that would impede completion of DaTscanTM (subject weight above 158 kg should be discussed with the Clinical Monitor)
  12. Resides in a nursing home or assisted care facility.
  13. Use of investigational drugs (other than imaging agents) or devices (other than mobile/wearable devices used in this study) within 60 days or 5 half-lives of study agent prior to baseline and during the study period.

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): NCT03681015


Contacts
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Contact: Elisabeth A de Blieck, MPA (585) 273-4243 lisa.deblieck@chet.rochester.edu
Contact: Rachel O'Loughlin (585) 273-2879 rachel.oloughlin@chet.rochester.edu

Locations
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United States, Arizona
Banner Sun Research Institute Not yet recruiting
Sun City, Arizona, United States, 85351
Principal Investigator: David Shprecher, MD         
United States, California
University of Caifornia Davis Not yet recruiting
Sacramento, California, United States, 95817
Principal Investigator: Lin Zhang, MD         
University of California San Francisco Not yet recruiting
San Francisco, California, United States, 94115
Contact: Danilo Romero       danilo.romero@ucsf.edu   
Principal Investigator: Tanner Caroline, MD         
United States, Colorado
University of Colorado Denver Not yet recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Brian Berman, MD MS         
United States, Florida
University of South Florida Not yet recruiting
Tampa, Florida, United States, 33613
Principal Investigator: Deborah Burke, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Sharnia Lashley       clinicaltrials.gov@northwestern.edu   
Principal Investigator: Cynthia Poon         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Angela Stovall       astovall@med.umich.edu   
Principal Investigator: Kelvin Chou, MD         
Michigan State University Not yet recruiting
East Lansing, Michigan, United States, 48824
Contact: Doozie Russell       sniderm@msu.edu   
Principal Investigator: John L Goudreau, DO PhD         
United States, Nevada
Cleveland Clinic Nevada Not yet recruiting
Las Vegas, Nevada, United States, 89106
Principal Investigator: Zoltan Mari, MD         
United States, New York
Northwell Health Not yet recruiting
Great Neck, New York, United States, 11021
Principal Investigator: Ritesh Ramdhani, MD         
NYU Langone Health Not yet recruiting
New York, New York, United States, 10017
Contact: Daniella Mania       Daniella.mania@nyulangone.org   
Principal Investigator: Andrew Feigin, MD         
Columbia University Not yet recruiting
New York, New York, United States, 10032
Principal Investigator: Hiral Shah, MD         
University of Rochester Recruiting
Rochester, New York, United States, 14620
Contact: Emma Waddell    585-276-6825    emma.waddell@chet.rochester.edu   
Principal Investigator: Adams Jamie, MD         
United States, North Carolina
Wake Forest University Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Jessica Dimos       jdimos@wakehealth.edu   
Principal Investigator: Mustafa Siddiqui, MD         
United States, Ohio
University of Cincinnati Not yet recruiting
Cincinnati, Ohio, United States, 45219
Principal Investigator: Alberto Espay, MD MSC         
University Hospitals Cleveland Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: Steven Gunzler, MD         
United States, Oregon
Oregon Health and Science University Not yet recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Penelope Hogarth, MD         
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Meredith Spindler, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Christine Hunter       chunter@bcm.edu   
Principal Investigator: Arjun Tarakad, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Katie L Sullivan       kls8d@virginia.edu   
Principal Investigator: Matthew Barrett, MD MSC         
Sponsors and Collaborators
University of Rochester
Biogen
Investigators
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Principal Investigator: Earl R Dorsey, MD MBA University of Rochester

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Responsible Party: Ray Dorsey, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03681015     History of Changes
Other Study ID Numbers: WPD-01
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases