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Parkinson DiseaseNCT06219629

Parkinson's Disease Progression Study

An observational study of Parkinson Disease, run by Koneksa Health at 10 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Disease Progression Study Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Parkinson Disease
How many people
82 participants
Where
10 sitesUnited States
Study dates
20 Feb 2024to Feb 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with Parkinson's disease

Who may be able to join

  • Aged ≥18 years to ≤85 years of age.
  • Body mass index (BMI) ≥18 to 40 kg/m2.
  • 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.
  • Participant or caregiver has demonstrated ability to perform satisfactory in-clinic and remote procedures during the screening period.
  • Clinically established PD, consistent with Postuma et al (Mov Disord; 2015).
  • H\&Y stage 1 or 2.

Who cannot join

  • Unable to commit to 12 months of data collection.
  • Planning to enroll in a clinical trial for disease modifying therapy that will overlap with the duration of this study.
  • Parkinsonism due to drugs(s) and or toxin(s).
  • Increased risk of falling, defined as >6 falls within the 12 months prior to screening.
  • Urine drug screen positive for opiates, phencyclidine (PCP), cocaine, or amphetamines.
  • Regular binge drinking, defined as ≥4 alcoholic drinks for women or ≥5 alcoholic drinks for men, per investigator assessment.
Show all 21Show fewer
  • 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.
  • Severe cardiopulmonary, hepatic, renal, or musculoskeletal disease such that activities of daily living are adversely impacted.
  • 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.
  • 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.
  • Current or planned pregnancy.
  • History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury (other than mild traumatic brain injury).
  • Intracranial metallic or magnetic devices, such as a cochlear implant or deep brain stimulator.
  • Implanted active device, such as a pacemaker or defibrillator.
  • History of gene therapy, intracranial antisense oligonucleotide treatment, cell transplantation, or experimental brain surgery.
  • Current untreated or unstable depressive disorder or a serious mood disorder requiring hospitalization.
  • Other primary degenerative dementia or neurodegenerative conditions outside of the specific basket in which the participant is enrolled, where applicable.
  • 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.
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Augusta University Health Movement Disorder Clinic

    Augusta, Georgia, 30912

  • University of Colorado Health Neurosciences Center

    Aurora, Colorado, 80045

  • Parkinsons Disease And Movement Disorders Center Of Boca Raton

    Boca Raton, Florida, 33486

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Accel Research Sites DeLand

    DeLand, Florida, 32720

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • University of Kansas Medical Center Parkinson's Disease and Movement Disorder Center

    Kansas City, Kansas, 66160

  • Accel Research Sites St Petersburg-Largo

    Largo, Florida, 33777

  • Cleveland Clinic

    Las Vegas, Nevada, 89106

  • N1 Research LLC

    Orlando, Florida, 32825

Other trials in United States

About this study

Official title: 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

Read the 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.

Medical subject headings
Parkinson Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compliance; toolkit assessments

    Percentage of total toolkit tasks completed during the remote data collection period

    Measured: Baseline Day 1 through Day 365 End of Participation

Secondary outcomes (1)

  1. Usability; mobile application

    Percentage of participants reporting a mobile application System Usability Scale (SUS) score ≥68

    Measured: Baseline Day 1 through Day 365 End of Participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start20 Feb 2024
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06219629
Sponsor's protocol ID
KH007
Status last verified
Mar 2025
First submitted
4 Dec 2023
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Koneksa Health at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance; toolkit assessments (time frame: Baseline Day 1 through Day 365 End of Participation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06219629.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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Parkinson's Disease Progression Study (NCT06219629) | AzTrials