Parkinson's Disease Progression Study

September 2, 2025 updated by: Koneksa Health

A Two Part, Observational Basket Study to Determine Usability, Validity and Biomarker Discovery for Mobile EEG, Wearable and Device Collected Objective Measurement of Disturbed Sleep and Neurologic Disorders (LEARNS)

Disease Progression Study

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a longitudinal, observational Study to Determine Usability, Analytical and Clinical Validity and Biomarker Discovery for Wearable and Mobile Device Collected Objective Measurement of Disturbed Sleep and Neurologic Disorders. The Disease Progression Study part in Parkinson's Disease has a duration of approximately 12 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health Neurosciences Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinsons Disease And Movement Disorders Center Of Boca Raton
      • DeLand, Florida, United States, 32720
        • Accel Research Sites DeLand
      • Largo, Florida, United States, 33777
        • Accel Research Sites St Petersburg-Largo
      • Orlando, Florida, United States, 32825
        • N1 Research LLc
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University Health Movement Disorder Clinic
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center Parkinson's Disease and Movement Disorder Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • QUEST Research Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Parkinson's disease

Description

Inclusion criteria:

  1. Aged ≥18 years to ≤85 years of age.
  2. Body mass index (BMI) ≥18 to 40 kg/m2.
  3. In adequate health based on medical history and physical examination (other than PD) undertaken following standard care procedures and presenting minimal risk for taking part in the study, per investigator assessment.
  4. Participant or caregiver has demonstrated ability to perform satisfactory in-clinic and remote procedures during the screening period.
  5. Clinically established PD, consistent with Postuma et al (Mov Disord; 2015).
  6. H&Y stage 1 or 2.

Exclusion criteria:

  1. Unable to commit to 12 months of data collection.
  2. Planning to enroll in a clinical trial for disease modifying therapy that will overlap with the duration of this study.
  3. Parkinsonism due to drugs(s) and or toxin(s).
  4. Increased risk of falling, defined as >6 falls within the 12 months prior to screening.
  5. Urine drug screen positive for opiates, phencyclidine (PCP), cocaine, or amphetamines.
  6. Regular binge drinking, defined as ≥4 alcoholic drinks for women or ≥5 alcoholic drinks for men, per investigator assessment.
  7. Current or recent (within 6 months prior to screening) diagnosis of a moderate or severe substance use disorder (excluding caffeine) according to Diagnostic and Statistical Manual of Mental Disorders-5 criteria. Note that nicotine use disorder is an exclusion criterion only if it has an effect on sleep (i.e., a participant who routinely awakens at night to smoke), and medical or recreational marijuana is not included in this exclusion criterion.
  8. Severe cardiopulmonary, hepatic, renal, or musculoskeletal disease such that activities of daily living are adversely impacted.
  9. History of neoplastic disease, with the exception of (1) an adequately treated basal cell carcinoma or carcinoma in situ of the cervix; (2) other malignancies which have been successfully treated >5 years prior to screening without evidence of recurrence.
  10. Currently participating in another clinical trial, or previous participation in a clinical trial in which an investigational product was received within 30 days prior to screening or within at least 5 half-lives of the investigational product.
  11. Current or planned pregnancy.
  12. History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury (other than mild traumatic brain injury).
  13. Intracranial metallic or magnetic devices, such as a cochlear implant or deep brain stimulator.
  14. Implanted active device, such as a pacemaker or defibrillator.
  15. History of gene therapy, intracranial antisense oligonucleotide treatment, cell transplantation, or experimental brain surgery.
  16. Current untreated or unstable depressive disorder or a serious mood disorder requiring hospitalization.
  17. Other primary degenerative dementia or neurodegenerative conditions outside of the specific basket in which the participant is enrolled, where applicable.
  18. Other uncontrolled infectious, metabolic, or systemic diseases affecting the central nervous system, such as syphilis, hypothyroidism, vitamin B12 or folate deficiency, and other laboratory values.
  19. Any other medical, psychiatric, or social condition that, in the opinion of the investigator, is likely to unfavorably alter the risk-benefit of participation, to interfere with protocol compliance, or to confound safety or efficacy assessments.

Additional exclusion criterion for the subset of treatment-naive participants only:

1. No prior treatment to manage motor symptoms of PD; note that brief periods of dopaminergic therapy administered to establish diagnosis are not grounds for exclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Compliance; toolkit assessments
Time Frame: Baseline Day 1 through Day 365 End of Participation
Percentage of total toolkit tasks completed during the remote data collection period
Baseline Day 1 through Day 365 End of Participation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Usability; mobile application
Time Frame: Baseline Day 1 through Day 365 End of Participation
Percentage of participants reporting a mobile application System Usability Scale (SUS) score ≥68
Baseline Day 1 through Day 365 End of Participation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compliance; by category
Time Frame: Baseline Day 1 through Day 365 End of Participation
Percentage of toolkit assessments completed, by category (motor, speech, and cognitive)
Baseline Day 1 through Day 365 End of Participation
Compliance; by assessment
Time Frame: Baseline Day 1 through Day 365 End of Participation
Percentage of toolkit assessments completed, by individual assessment
Baseline Day 1 through Day 365 End of Participation
Compliance; wrist-worn device
Time Frame: Baseline Day 1 through Day 365 End of Participation
Compliance with the wrist-worn device in hours/day
Baseline Day 1 through Day 365 End of Participation
Usability; study phone
Time Frame: Baseline Day 1 through Day 365 End of Participation
Usability of the study phone, evaluated with the usability questionnaire
Baseline Day 1 through Day 365 End of Participation
Usability; study tablet
Time Frame: Baseline Day 1 through Day 365 End of Participation
Usability of the study tablet, evaluated with the usability questionnaire
Baseline Day 1 through Day 365 End of Participation
Usability; wrist-worn device
Time Frame: Baseline Day 1 through Day 365 End of Participation
Usability of the wrist-worn device, evaluated with the usability questionnaire
Baseline Day 1 through Day 365 End of Participation
Usability; software platform
Time Frame: Baseline Day 1 through Day 365 End of Participation
Usability of the SaaS platform, evaluated with the usability questionnaire
Baseline Day 1 through Day 365 End of Participation
Usable data; toolkit assessments
Time Frame: Baseline Day 1 through Day 365 End of Participation
Percentage of total toolkit assessments that generate usable data
Baseline Day 1 through Day 365 End of Participation
Usable data; by category
Time Frame: Baseline Day 1 through Day 365 End of Participation
Percentage of toolkit assessments that generate usable data, by category (motor, speech, and cognitive)
Baseline Day 1 through Day 365 End of Participation
Usable data; by assessment
Time Frame: Baseline Day 1 through Day 365 End of Participation
Percentage of toolkit assessments that generate usable data, by individual assessment
Baseline Day 1 through Day 365 End of Participation
Usable data; wrist-worn device
Time Frame: Baseline Day 1 through Day 365 End of Participation
Amount of usable data obtained from the wrist-worn device
Baseline Day 1 through Day 365 End of Participation
Content validity; by assessment
Time Frame: Baseline Day 1 through Day 365 End of Participation
Content validity evaluated with the in-house content validity survey, by toolkit assessment
Baseline Day 1 through Day 365 End of Participation
Content validity; by PRO
Time Frame: Baseline Day 1 through Day 365 End of Participation
Content validity evaluated with the in-house content validity survey, by PRO
Baseline Day 1 through Day 365 End of Participation
Criterion validity; toolkit assessments
Time Frame: Baseline Day 1 through Day 365 End of Participation
Criterion validity evaluated by examining associations between measures derived from the toolkit assessments and disease-specific gold-standard assessments
Baseline Day 1 through Day 365 End of Participation
Criterion validity; wrist-worn device
Time Frame: Baseline Day 1 through Day 365 End of Participation
Criterion validity evaluated by examining associations between measures derived from the wrist-worn device and disease-specific gold-standard assessments
Baseline Day 1 through Day 365 End of Participation
Construct validity; by data capture location
Time Frame: Baseline Day 1 through Day 365 End of Participation
Evaluation of the differences between measures obtained remotely versus in-clinic
Baseline Day 1 through Day 365 End of Participation
Construct validity; by data capture frequency
Time Frame: Baseline Day 1 through Day 365 End of Participation
Evaluation of the differences between measures obtained at different frequencies, such as daily vs weekly
Baseline Day 1 through Day 365 End of Participation
Convergent validity; motor assessments
Time Frame: Baseline Day 1 through Day 365 End of Participation
Convergent validity evaluated by examining associations between measures derived from the motor assessments
Baseline Day 1 through Day 365 End of Participation
Convergent validity; cognitive assessments
Time Frame: Baseline Day 1 through Day 365 End of Participation
Convergent validity evaluated by examining associations between measures derived from the cognitive assessments
Baseline Day 1 through Day 365 End of Participation
Convergent validity; speech assessments
Time Frame: Baseline Day 1 through Day 365 End of Participation
Convergent validity evaluated by examining associations between measures derived from the speech assessments
Baseline Day 1 through Day 365 End of Participation
Discriminant validity; toolkit assessments
Time Frame: Baseline Day 1 through Day 365 End of Participation
Discriminant validity evaluated by examining associations between measures derived from toolkit assessments identified between categories (motor vs cognitive vs speech)
Baseline Day 1 through Day 365 End of Participation
Evaluation of change; toolkit assessments
Time Frame: Baseline Day 1 through Day 365 End of Participation
Evaluation of change over time in measures derived from the toolkit assessments
Baseline Day 1 through Day 365 End of Participation
Evaluation of change; wrist-worn device
Time Frame: Baseline Day 1 through Day 365 End of Participation
Evaluation of change over time in measures derived from the wrist-worn device
Baseline Day 1 through Day 365 End of Participation
Detection of disease progression; toolkit assessments
Time Frame: Baseline Day 1 through Day 365 End of Participation
Evaluation of change over time in measures derived from the toolkit assessments, comparing progressors and non-progressors as defined by the PGI-C
Baseline Day 1 through Day 365 End of Participation
Detection of disease progression; wrist-worn device
Time Frame: Baseline Day 1 through Day 365 End of Participation
Evaluation of change over time in measures derived from the wrist-worn device, comparing progressors and non-progressors as defined by the PGI-C
Baseline Day 1 through Day 365 End of Participation
Test-retest reliability; toolkit assessments
Time Frame: Baseline Day 1 through Day 365 End of Participation
Test-retest reliability evaluated by examining associations between measures derived from the toolkit assessment device captured at adjacent timepoint
Baseline Day 1 through Day 365 End of Participation
Internal consistency reliability; Cronbach's alpha
Time Frame: Baseline Day 1 through Day 365 End of Participation
Internal consistency reliability evaluated by examining Cronbach's alpha (for composite scores only, as applicable)
Baseline Day 1 through Day 365 End of Participation
Internal consistency reliability; item-total associations
Time Frame: Baseline Day 1 through Day 365 End of Participation
Internal consistency reliability evaluated by examining item-total associations (for composite scores only, as applicable
Baseline Day 1 through Day 365 End of Participation
Internal consistency reliability; directionality of change
Time Frame: Baseline Day 1 through Day 365 End of Participation
Internal consistency reliability evaluated by comparing the directionality of change in individual components (for composite scores only, as applicable)
Baseline Day 1 through Day 365 End of Participation
Minimum valid dataset
Time Frame: Baseline Day 1 through Day 365 End of Participation
Determination of the minimum valid dataset required to monitor disease progression
Baseline Day 1 through Day 365 End of Participation
Comparison of digital and non-digital biomarkers/assessments; toolkit assessments
Time Frame: Baseline Day 1 through Day 365 End of Participation
Evaluation of the associations between measures derived from the toolkit assessments and non-digital biomarkers
Baseline Day 1 through Day 365 End of Participation
Comparison of digital and non-digital biomarkers/assessments; wrist-worn device
Time Frame: Baseline Day 1 through Day 365 End of Participation
Evaluation of the associations between measures derived from the wrist-device and non-digital biomarkers
Baseline Day 1 through Day 365 End of Participation
Subgroup analyses
Time Frame: Baseline Day 1 through Day 365 End of Participation
To evaluate the extent to which compliance, usability, usable data, validity, and reliability differ by subgroup/s
Baseline Day 1 through Day 365 End of Participation
Evaluation of composite scores
Time Frame: Baseline Day 1 through Day 365 End of Participation
Evaluation of the concepts listed above for composite scores, if applicable
Baseline Day 1 through Day 365 End of Participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Koneksa Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jessie P Bakker, PhD, Koneksa Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KH007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data that underlie results in a publication

IPD Sharing Time Frame

Upon preliminary analysis (if applicable) and end of study.

IPD Sharing Access Criteria

Publications will be shared with Clinical Site Investigators and industry professionals.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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