Non-invasive Diagnosis of Parkinson's Disease

N/ANot Yet RecruitingNCT07201610

Blekinge Institute of Technology60 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Parkinsons Disease (PD)

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Through study completion, an average of 6 months

Secondary Outcomes

Diagnostic performance of each modality on its own.

Diagnostic performance for each diagnostic modality, HSI, OCT, voice and cognitive testing

Time frame: 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

Time frame: Through study completion, an average of 6 months

Central Contacts

Anders Behrens, MD. PhD.

CONTACT

0046455731000 anders.behrens@bth.se

Data from ClinicalTrials.gov

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