Parkinsons Disease (PD)NCT07201610
Non-invasive Diagnosis of Parkinson's Disease
An observational study of Parkinsons Disease (PD), run by Blekinge Institute of Technology.
Trial summary
This study will investigate new, non-invasive methods to help diagnose Parkinson's disease. Researchers will use advanced eye imaging (hyperspectral retinal photography and OCT), computerized memory and thinking tests, and voice analysis to identify patterns linked to Parkinson's. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinsons Disease (PD)
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 16 Oct 2025to 16 Dec 2025
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Thirty consecutive patients with a diagnosis of idiopathic Parkinson's disease who are scheduled for routine follow-up visits at the Neurology Clinic in Karlskrona. After patient recruitment, 30 healthy controls matched by age and gender (1:1 matching) will be recruited from Blekinge Institute of Technology's (BTH) Research and Development Clinic. At the clinic, there is a list/mailbox where individuals can volunteer to participate in studies. The participants who best match the included Parkinson's patients will be invited to take part
Who may be able to join
- Age 60-80 years
- Diagnosis of idiopathic Parkinson's disease
- Ability to understand spoken and written Swedish
- Ability to personally provide consent to participate in the study
- At least one healthy eye for retinal photography
- Age 60-80 years
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- Ability to understand spoken and written Swedish
- Ability to personally provide consent to participate in the study
- At least one healthy eye for retinal photography
- Healthy as defined below
Who cannot join
- At least one eye must not have retinal disease, glaucoma, or vascular eye disease (such as embolism)
- Angle-closure glaucoma or other contraindication to mydriatic drops
- Low functional ability that makes participation in examinations impossible
- Diagnosed dementia
- Specifically for the control group: Not healthy according to the definition below
- Definition of healthy:
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- No diagnosed or suspected Parkinson's disease
- No diagnosed or suspected cognitive disease
- No psychiatric disease affecting cognition (e.g., psychotic disorder or major depression)
- Cognitive testing with MMSE ≥ 26 points (out of a maximum of 30) and ≥ 8 points on the clock-drawing test
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Non-invasive Diagnosis of Parkinson's Disease Using Hyperspectral Retinal Imaging, Optical Coherence Tomography, Computerized Cognitive Testing, and Voice Analysis
This study will investigate new, non-invasive methods to help diagnose Parkinson's disease. Researchers will use advanced eye imaging (hyperspectral retinal photography and OCT), computerized memory and thinking tests, and voice analysis to identify patterns linked to Parkinson's. The goal is to improve early and accurate diagnosis of Parkinson's disease without the need for spinal taps or invasive tests.
Read the detailed description
This study aims to improve how Parkinson's disease is diagnosed by testing new, non-invasive techniques that do not require spinal taps or other invasive procedures. Researchers are investigating whether changes in the eye's retina, detected with hyperspectral imaging and optical coherence tomography (OCT), can help pinpoint Parkinson's disease. These methods use special photographs and scans, similar to those performed at an eye clinic or optometrist, to analyze patterns linked to nerve cells and blood vessels in the retina.
Additionally, participants will take computerized tests to measure memory, attention, and thinking skills. Since Parkinson's disease can also affect speech, the study will analyze voice recordings for specific changes that are common in the disease, such as reduced volume and strength. By combining information from eye images, cognitive tests, and voice analysis, the project hopes to develop a faster and more accurate way to diagnose Parkinson's disease at an earlier stage.
The study is open to both people with Parkinson's disease and healthy volunteers, and the new diagnostic tools being tested could make future diagnosis simpler, more comfortable, and accessible to a wider population
- Conditions
- Parkinsons Disease (PD)
- Keywords
- Parkinson's disease, Non-invasive diagnosis, Hyperspectral retinal imaging, Optical coherence tomography, OCT, Computerized cognitive testing, Voice analysis, Biomarkers, Lewy body disease, Retinal biomarkers, Diagnostic accuracy, Neuropsychology, Machine learning
- Medical subject headings
- Parkinson Disease, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson disease | Inclusion criteria for Parkinson's group: * Age 60-80 years * Diagnosis of idiopathic Parkinson's disease * Ability to understand spoken and written Swedish * Ability to personally provide consent to participate in the study * At least one healthy eye for retinal photography | |
| Healthy controls | Inclusion criteria for control group: * Age 60-80 years * Ability to understand spoken and written Swedish * Ability to personally provide consent to participate in the study * At least one healthy eye for retinal photography Definition of healthy: * No diagnosed Parkinson's disease or currently under investigation for Parkinson's disease * No diagnosed cognitive disease or currently under investigation for cognitive disease * No psychiatric disease affecting cognition (e.g., psychotic disorder or major depression) * Cognitive testing score of MMSE ≥ 26 points (out of a maximum of 30) and ≥ 8 points on the clock-drawing test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of combined model, retinal, voice and cognitive data
To assess the performance (AUC) of an optimized diagnostic model that combines HSI, OCT, and angio-OCT data with computerized cognitive testing and voice analysis for identifying Parkinson's disease
Measured: Through study completion, an average of 6 months
Performance retinal biomarkers
To evaluate the performance (AUC) of a diagnostic model that combines hyperspectral retinal imaging (HSI), and optimally selected data from OCT and angio-OCT, for classifying patients with Parkinson's disease
Measured: Through study completion, an average of 6 months
Secondary outcomes (2)
Diagnostic performance of each modality on its own.
Diagnostic performance for each diagnostic modality, HSI, OCT, voice and cognitive testing
Measured: Through study completion, an average of 6 months
Correlational analyses
Correlation measures for each retinal modality with cognition and functional scale for Parkinson's disease
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start16 Oct 2025 (estimated)
- Primary completion16 Dec 2025 (estimated)
- Study completion16 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsons Disease (PD)Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blekinge Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Region Blekinge
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201610
- Sponsor's protocol ID
- ps_hsi
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be shared upon request from a regarded trustworthy academic partner for replicating purposes only.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Diagnosis of Parkinson's Disease Using Hyperspectral Retinal Imaging, Optical Coherence Tomography, Computerized Cognitive Testing, and Voice Analysis
- ClinicalTrials.gov ID
- NCT07201610
- Acronym / sponsor ID
- ps_hsi
- Conditions
- Parkinsons Disease (PD)
- Keywords
- Parkinson's disease, Non-invasive diagnosis, Hyperspectral retinal imaging, Optical coherence tomography, OCT, Computerized cognitive testing, Voice analysis, Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Blekinge Institute of TechnologyUniversity, hospital or other
- Collaborators
- Region Blekinge
- Study start
- 16 Oct 2025 (estimated)
- Primary completion
- 16 Dec 2025 (estimated)
- Study completion
- 16 Dec 2025 (estimated)
- First posted
- 1 Oct 2025 (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.
This study will investigate new, non-invasive methods to help diagnose Parkinson's disease. Researchers will use advanced eye imaging (hyperspectral retinal photography and OCT), computerized memory and thinking tests, and voice analysis to identify patterns linked to Parkinson's. The goal is to improve early and accurate diagnosis of Parkinson's disease without the need for spinal taps or invasive tests.
Detailed description
This study aims to improve how Parkinson's disease is diagnosed by testing new, non-invasive techniques that do not require spinal taps or other invasive procedures. Researchers are investigating whether changes in the eye's retina, detected with hyperspectral imaging and optical coherence tomography (OCT), can help pinpoint Parkinson's disease. These methods use special photographs and scans, similar to those performed at an eye clinic or optometrist, to analyze patterns linked to nerve cells and blood vessels in the retina.
Additionally, participants will take computerized tests to measure memory, attention, and thinking skills. Since Parkinson's disease can also affect speech, the study will analyze voice recordings for specific changes that are common in the disease, such as reduced volume and strength. By combining information from eye images, cognitive tests, and voice analysis, the project hopes to develop a faster and more accurate way to diagnose Parkinson's disease at an earlier stage.
The study is open to both people with Parkinson's disease and healthy volunteers, and the new diagnostic tools being tested could make future diagnosis simpler, more comfortable, and accessible to a wider population
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson disease | – | –Inclusion criteria for Parkinson's group: * Age 60-80 years * Diagnosis of idiopathic Parkinson's disease * Ability to understand spoken and written Swedish * Ability to personally provide consent to participate in the study * At least one healthy eye for retinal photography |
| Healthy controls | – | –Inclusion criteria for control group: * Age 60-80 years * Ability to understand spoken and written Swedish * Ability to personally provide consent to participate in the study * At least one healthy eye for retinal photography Definition of healthy: * No diagnosed Parkinson's disease or currently under investigation for Parkinson's disease * No diagnosed cognitive disease or currently under investigation for cognitive disease * No psychiatric disease affecting cognition (e.g., psychotic disorder or major depression) * Cognitive testing score of MMSE ≥ 26 points (out of a maximum of 30) and ≥ 8 points on the clock-drawing test |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty consecutive patients with a diagnosis of idiopathic Parkinson's disease who are scheduled for routine follow-up visits at the Neurology Clinic in Karlskrona. After patient recruitment, 30 healthy controls matched by age and gender (1:1 matching) will be recruited from Blekinge Institute of Technology's (BTH) Research and Development Clinic. At the clinic, there is a list/mailbox where individuals can volunteer to participate in studies. The participants who best match the included Parkinson's patients will be invited to take part
Key inclusion criteria (10 listed)
- Age 60-80 years
- Diagnosis of idiopathic Parkinson's disease
- Ability to understand spoken and written Swedish
- Ability to personally provide consent to participate in the study
- At least one healthy eye for retinal photography
Key exclusion criteria (10 listed)
- At least one eye must not have retinal disease, glaucoma, or vascular eye disease (such as embolism)
- Angle-closure glaucoma or other contraindication to mydriatic drops
- Low functional ability that makes participation in examinations impossible
- Diagnosed dementia
- Specifically for the control group: Not healthy according to the definition below
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance of combined model, retinal, voice and cognitive data
Time frame: Through study completion, an average of 6 months
To assess the performance (AUC) of an optimized diagnostic model that combines HSI, OCT, and angio-OCT data with computerized cognitive testing and voice analysis for identifying Parkinson's disease
Performance retinal biomarkers
Time frame: Through study completion, an average of 6 months
To evaluate the performance (AUC) of a diagnostic model that combines hyperspectral retinal imaging (HSI), and optimally selected data from OCT and angio-OCT, for classifying patients with Parkinson's disease
2 secondary outcomes
Diagnostic performance of each modality on its own.
Time frame: Through study completion, an average of 6 months
Correlational analyses
Time frame: Through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Yes. Anonymised data will be shared upon request from a regarded trustworthy academic partner for replicating purposes only.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinsons Disease (PD), run by Blekinge Institute of Technology.
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 10 inclusion and 10 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: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Anders Behrens, MD. PhD. (0046455731000, anders.behrens@bth.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of combined model, retinal, voice and cognitive data (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025.