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NCT Number: NCT07201610

Non-invasive Diagnosis of Parkinson's Disease

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Diagnostic performance of each modality on its own.

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

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

  2. Correlational analyses

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

    Correlation measures for each retinal modality with cognition and functional scale for Parkinson's disease

Study contacts

Contact information is provided by the study sponsor or research team.

Anders Behrens, MD. PhD.

CONTACT

[email protected]

0046455731000

Sponsors and collaborators

Lead sponsor

Blekinge Institute of Technology

Other

Collaborators

  • Region Blekinge

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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