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
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Condition or disease |
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Parkinson Disease |
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 |

- 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.
- 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.
- 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.
- 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.

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: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Able to give written informed consent, as determined by the investigator.
- 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.
- Screening dopamine transporter (DAT) SPECT scan is consistent with dopamine transporter deficit.
- A diagnosis of Parkinson disease for 2 years or less at screening.
- Modified Hoehn and Yahr stage I or II at screening.
- 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).
- Male or female age 30 years or older at time of PD diagnosis.
- 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).
- 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).
- Fluent in English and able to read.
- 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:
- A diagnosis of atypical parkinsonism, drug-induced parkinsonism, essential tremor, primary dystonia or other diagnoses that explain symptoms other than PD.
- History of PD-related freezing episodes or falls.
- 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.
- History of a brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality as determined by the investigator.
- 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.
- 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.
- 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.
- Montreal Cognitive Assessment (MoCA) score < 26 at baseline.
- 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
- Known hypersensitivity to DaTscanTM or any of its excipients
- Body habitus that would impede completion of DaTscanTM (subject weight above 158 kg should be discussed with the Clinical Monitor)
- Resides in a nursing home or assisted care facility.
- 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.

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
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 |
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 |
Principal Investigator: | Earl R Dorsey, MD MBA | University of Rochester |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |