Parkinson DiseaseDiSCERNNCT05351580
DiSCERN: Advanced PD Therapy Candidacy and Evaluation System
An observational study of Parkinson Disease, run by Great Lakes NeuroTechnologies Inc. at 2 sites in United States.
Trial summary
To collect data to develop models that identify when patients with advanced Parkinson's disease (PD) are not responding well to their current therapy and may be ready to consider advanced therapy and when patients receiving advanced therapy are not responding well and need a therapy adjustment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- DiSCERN
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jul 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our three clinical sites will recruit a total of 60 individuals diagnosed with advanced PD who regularly take levodopa. At least half the subjects will have already been identified as candidates for DBS or LCIG, but before their surgeries take place. The remainder will be non-demented (MoCA > 24) advanced PD patients as defined by having a UPDRS motor complications scores ≥ 4. All participants must be ambulatory and capable of using the smartphone-based DiSCERN system either independently or with the help of a caregiver.
Who may be able to join
- Able to provide informed consent
- Diagnosed with Parkinson's disease
- Current levodopa use
- Hoehn and Yahr scale II-III
- Ambulatory and capable of using the DiSCERN smartphone system
- Able to understand and follow instructions regarding using the device
- Half of participants (10 per site) identified as candidates for deep brain stimulation or drug pump by their treating neurologist, but before their surgeries take place.
- The remainder (10 per site) will be individuals with advanced PD as defined by having a UPDRS motor complications scores ≥ 4.
Who cannot join
- Any subject that does not meet the inclusion criteria will be excluded from this study. Subjects not capable of following the required clinical instruction for this study will be excluded. Potential subjects will be screened to ensure no cognitive impairments exist that would prohibit them from properly using the system. Exclusion criteria includes cognitive impairment as evidenced by a score less than 24 on the Montreal Cognitive Assessment (MoCA) UNLESS the subject has a caregiver able and willing to facilitate use of the DiSCERN system based on the judgement of the treating neurologist.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Cincinnati
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: DiSCERN: Advanced PD Therapy Candidacy and Evaluation System - Advanced PD Data Collection
To collect data to develop models that identify when patients with advanced Parkinson's disease (PD) are not responding well to their current therapy and may be ready to consider advanced therapy and when patients receiving advanced therapy are not responding well and need a therapy adjustment.
- Conditions
- Parkinson Disease
- Being tested
- DiSCERN
- Keywords
- Dyskinesia, Parkinson's Disease, Deep brain stimulation, Wearable
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiSCERNDevice
Smart watch Monitoring
| Study group | Role | What they receive |
|---|---|---|
| Advanced Parkinson's disease patients who receive advance therapy during the study | All participants will have advanced Parkinson's disease and undergo smart watch monitoring. Participants in this cohort will be those who receive advance therapy during the study. Receives: Device: DiSCERN | |
| Advanced Parkinson's disease patients who do not receive advance therapy during the study | All participants will have advanced Parkinson's disease and undergo smart watch monitoring. Participants in this cohort will be those who do not receive advance therapy during the study. Receives: Device: DiSCERN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severities
Symptom severities measured by smart watch
Measured: Eight (8) months compared to baseline
Secondary outcomes (5)
Unified Parkinson's Disease Rating Scale (UPDRS) Part III
UPDRS Part III has 33 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Each of the 33 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The motor score ranges from 0 to 132, where the maximum score indicates the worse condition. A negative value in change indicates improvement, whereas a positive value indicates worsening of disease.
Measured: Eight (8) months compared to baseline
Kinesia ONE motor assessment
Measured: Eight (8) months compared to baseline
Parkinson's Disease Questionnaire (PDQ-39)
The PD Quality of Life Questionnaire-39 (PDQ-39) is a self-report questionnaire that examines health related difficulties specific to PD in eight quality of life categories within the last month. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100, with higher % indicating more health problems.
Measured: Eight (8) months compared to baseline
Montreal Cognitive Assessment (MoCA)
The MoCA consists of 30 test items that assess visuospatial and executive functioning, naming, memory, attention, language, abstraction, delayed recall, and orientation. Each correct answer is awarded one point, which are added to create a total score. A higher score is a better outcome and indicates less cognitive impairment.
Measured: Eight (8) months compared to baseline
MANAGE-PD questionnaire
MANAGE-PD is designed to support healthcare providers in the identification of patients with Parkinson's Disease uncontrolled on oral medications. The questionnaire consists of two sections and should be answered based on symptoms during the last month. Patients are categorized into three categories based on responses:
Category 1: Patient may be controlled on the current treatment regimen. Category 2: Patient may not be controlled on the current treatment regimen. Category 3: Patient may not be controlled on the current treatment regimen and may benefit from device-aided therapy.
Measured: Eight (8) months compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start21 Jul 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Cincinnati, The Cleveland Clinic, National Institute on Minority Health and Health Disparities (NIMHD), Ohio State University
- Responsible party
- Principal investigator, Dustin Heldman, Great Lakes NeuroTechnologies Inc.
- Investigators
- Dustin A Heldman, PhD, Principal investigator, Great Lakes NeuroTechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351580
- Sponsor's protocol ID
- 5R44MD013767-03
- Other IDs
- 5R44MD013767-03
- Acronym
- DiSCERN
- Status last verified
- Aug 2025
- First submitted
- 15 Apr 2022
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heldman DA, Giuffrida JP, Cubo E. Wearable Sensors for Advanced Therapy Referral in Parkinson's Disease. J Parkinsons Dis. 2016 Jul 2;6(3):631-8. doi: 10.3233/JPD-160830.
PubMed 27392872
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiSCERN: Advanced PD Therapy Candidacy and Evaluation System - Advanced PD Data Collection
- ClinicalTrials.gov ID
- NCT05351580
- Acronym / sponsor ID
- DiSCERN / 5R44MD013767-03
- Conditions
- Parkinson Disease
- Keywords
- Dyskinesia, Parkinson's Disease, Deep brain stimulation, Wearable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Cincinnati, The Cleveland Clinic, National Institute on Minority Health and Health Disparities (NIMHD), Ohio State University
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To collect data to develop models that identify when patients with advanced Parkinson's disease (PD) are not responding well to their current therapy and may be ready to consider advanced therapy and when patients receiving advanced therapy are not responding well and need a therapy adjustment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Parkinson's disease patients who receive advance therapy during the study | – | Device: DiSCERNAll participants will have advanced Parkinson's disease and undergo smart watch monitoring. Participants in this cohort will be those who receive advance therapy during the study. |
| Advanced Parkinson's disease patients who do not receive advance therapy during the study | – | Device: DiSCERNAll participants will have advanced Parkinson's disease and undergo smart watch monitoring. Participants in this cohort will be those who do not receive advance therapy during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our three clinical sites will recruit a total of 60 individuals diagnosed with advanced PD who regularly take levodopa. At least half the subjects will have already been identified as candidates for DBS or LCIG, but before their surgeries take place. The remainder will be non-demented (MoCA > 24) advanced PD patients as defined by having a UPDRS motor complications scores ≥ 4. All participants must be ambulatory and capable of using the smartphone-based DiSCERN system either independently or with the help of a caregiver.
Key inclusion criteria (8 listed)
- Able to provide informed consent
- Diagnosed with Parkinson's disease
- Current levodopa use
- Hoehn and Yahr scale II-III
- Ambulatory and capable of using the DiSCERN smartphone system
Key exclusion criteria (1 listed)
- Any subject that does not meet the inclusion criteria will be excluded from this study. Subjects not capable of following the required clinical instruction for this study will be excluded. Potential subjects will be screened to ensure no cognitive impairments exist that would prohibit them from properly using the system. Exclusion criteria includes cognitive impairment as evidenced by a score less than 24 on the Montreal Cognitive Assessment (MoCA) UNLESS the subject has a caregiver able and willing to facilitate use of the DiSCERN system based on the judgement of the treating neurologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiSCERNSmart watch Monitoring | Device | Advanced Parkinson's disease patients who do not receive advance therapy during the study, Advanced Parkinson's disease patients who receive advance therapy during the study |
Primary outcome
Symptom severities
Time frame: Eight (8) months compared to baseline
Symptom severities measured by smart watch
5 secondary outcomes
Unified Parkinson's Disease Rating Scale (UPDRS) Part III
Time frame: Eight (8) months compared to baseline
Kinesia ONE motor assessment
Time frame: Eight (8) months compared to baseline
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Eight (8) months compared to baseline
Montreal Cognitive Assessment (MoCA)
Time frame: Eight (8) months compared to baseline
MANAGE-PD questionnaire
Time frame: Eight (8) months compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Background: PubMed 27392872Heldman DA, Giuffrida JP, Cubo E. Wearable Sensors for Advanced Therapy Referral in Parkinson's Disease. J Parkinsons Dis. 2016 Jul 2;6(3):631-8. doi: 10.3233/JPD-160830.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dustin A Heldman, PhD principal investigator
Great Lakes NeuroTechnologies Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Great Lakes NeuroTechnologies Inc. at 2 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 8 inclusion and 1 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: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptom severities (time frame: Eight (8) months compared to baseline). 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 NCT05351580, which also lists 1 linked publication.
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 26 Aug 2025.