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Non-invasive Diagnosis of Parkinson's Disease

Non-invasive Diagnosis of Parkinson's Disease Using Hyperspectral Retinal Imaging, Optical Coherence Tomography, Computerized Cognitive Testing, and Voice Analysis

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07201610
Enrollment
60
Registered
2025-10-01
Start date
2025-10-16
Completion date
2025-12-16
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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. 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

Interventions

None listed

Sponsors

Region Blekinge
CollaboratorUNKNOWN
Blekinge Institute of Technology
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes

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 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 * Healthy as defined below

Exclusion criteria

* 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: * 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

Design outcomes

Primary

MeasureTime frameDescription
Performance of combined model, retinal, voice and cognitive dataThrough study completion, an average of 6 monthsTo 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 biomarkersThrough study completion, an average of 6 monthsTo 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

Secondary

MeasureTime frameDescription
Diagnostic performance of each modality on its own.Through study completion, an average of 6 monthsDiagnostic performance for each diagnostic modality, HSI, OCT, voice and cognitive testing
Correlational analysesThrough study completion, an average of 6 monthsCorrelation measures for each retinal modality with cognition and functional scale for Parkinson's disease

Contacts

Primary ContactAnders Behrens, MD. PhD.
anders.behrens@bth.se0046455731000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026