Clinical trial NCT05153356: A Prospective Longitudinal Assessment of PD Functional Impairment and Disability Via Mobile Health Technology
Official title: A Prospective Longitudinal Assessment of Parkinson's Disease Functional Impairment and Disability Via Mobile Health Technology
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Parkinson Disease
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Personal Kinetigraph
timeFrame: 3 months
measure: Kinesia 360
timeFrame: 3 months
measure: MDS-UPDRS
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rush University Medical Center
name: Deborah A Hall, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: