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

NCT ID: NCT05153356

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-03-31

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.

Detailed Description

Mobile health technologies include the wearable sensor technologies that are body-worn and passively collect information and mobile devices like smartphones that can be frequently used by patients to actively or passively collect information. However, there has been limited comparison of different wearable technologies to validated clinical rating scales to allow us to come to a consensus about their utility in both clinical practice and research trials. Data from mobile health technologies in Parkinson's Disease (PD) have not been validated to use in the place of clinician rating scales. It is also not clear if the information obtained with the devices consistently correlates with change on the clinician scales and longitudinal motor decline. Technological challenges, such as the feasibility (safety, compliance) of use devices in patients with neurodegenerative disease, change in equipment and algorithms over time, collaboration with companies who may own patents, and other issues may also limit their use in healthcare and research. 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 PD patients. The hypothesis is that there will be an association between data from mobile health technologies and data obtained from validated questionnaires/scales, indicating that these technologies are a reliable means of monitoring motor symptomatology and functional impairment and disability over time. The primary aims of the study are to compare information on continuously-measured patient-reported PD-related functional impairment and disability changes from traditional validated questionnaires to continuously-measured health-related data from a battery of novel mobile health technologies, and to assess the feasibility (compliance, safety, satisfaction) of PD patients to use a battery of novel mobile health technologies.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Personal Kinetigraph, Kinesia 360

Intervention Type: 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.

Interventions

Personal Kinetigraph, Kinesia 360

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah A Hall, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Other Identifiers

20100709

Identifier Type: -

Identifier Source: org_study_id