A Prospective Longitudinal Assessment of PD Functional Impairment and Disability Via Mobile Health Technology

NCT05153356 | Withdrawn FDA Device

• 1 other identifier: 20100709
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare data from a battery of novel mobile health technologies to standard-of-care validated patient questionnaires and clinician rating scales in Parkinson's disease patients.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• Personal Kinetigraph

  Watch containing accelerometer and gyroscope for measurement of motor symptoms of PD

  3 months

• Kinesia 360

  2 sensor straps to wrist and ankle containing accelerometer and gyroscope for measurement of motor symptoms of PD.

  3 months

• MDS-UPDRS

  Part I assesses the non-motor aspects of experiences of daily living in the week prior to the visit. Part II assesses the motor aspects of experiences of daily living in the week prior to the visit. Part III assesses motor disabilities of a subject at the time of the visit and Part IV assesses motor complications in the week prior to the visit. A total of 46 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment.

  6 months

Study Arms (1)

Parkinson Disease patients

To examine the relationship between in-home continuous measures of tremor, bradykinesia, mobility, and dyskinesia acquired over a 7-day period, from 2 mobile health technologies (Personal Kinetigraph, Kinesia 360) with one-time in-clinic measures of motor functional ability pertaining to the same 7-day period as assessed by Part 2 of the MDS-UPDRS, Part 4 of the MDS-UPDRS, Neuro-QOL, and PDQ-39. This will be examined in n=20 patients (10 patients assigned to each technology with a crossover at 3 months for a total of 20 patients over 6 months, 6 timepoints with data collected every 2 weeks). Patients will then be following for an observational period of an additional 6 months.

Device: Personal Kinetigraph, Kinesia 360

Interventions

Personal Kinetigraph, Kinesia 360 DEVICE

10 patients will be assigned to each technology with a crossover at 3 months for a total of 20 patients over 6 months, 6 timepoints with data collected every 2 weeks.

Parkinson Disease patients

Eligibility Criteria

• Age: 35 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

20 patients with Parkinson Disease who are currently on levodopa treatment will be included in the study cohort. They must meet the inclusion/exclusion criteria.

You may qualify if:

• PD as defined by the UK Brain Bank Criteria
• Disease duration between 2-13 years
• Aged 35-68 years
• Hoehn \& Yahr stage 3 or less when in the levodopa-"ON" state

You may not qualify if:

• Atypical parkinsonism including 18F-dopa PET patterns consistent with this
• MMSE score of \< 24 or evidence for dementia using DSM-IV criteria
• Unable to do normal copying of interlocking pentagons and semantic fluency score \<20 over 90 secs
• Ongoing major medical or psychiatric disorder including depression and psychosis
• Other concomitant treatment with neuroleptics
• Significant drug induced dyskinesias (\>2 for any body part on the AIMS scale)
• Previous neurosurgery Unable to be imaged using MRI

Sponsors & Collaborators

• Rush University Medical Center: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Deborah A Hall, MD,PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: June 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share