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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

Tracking Information
First Submitted Date September 10, 2018
First Posted Date September 21, 2018
Last Update Posted Date October 8, 2019
Actual Study Start Date April 24, 2019
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 20, 2018)
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03681015 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 20, 2018)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Wearable Assessments in the Clinic and Home in PD
Official Title A Multicenter, Prospective, Longitudinal, Digital Assessment Study of Disease Progression in Subjects With Early, Untreated Parkinson Disease
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Parkinson Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 20, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 15, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03681015
Other Study ID Numbers WPD-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ray Dorsey, University of Rochester
Study Sponsor University of Rochester
Collaborators Biogen
Investigators
Principal Investigator: Earl R Dorsey, MD MBA University of Rochester
PRS Account University of Rochester
Verification Date October 2019