Non-invasive Diagnosis of Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Parkinsons Disease (PD). Basic parameters: 60 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Non-invasive Diagnosis of Parkinson's Disease Using Hyperspectral Retinal Imaging, Optical Coherence Tomography, Computerized Cognitive Testing, and Voice Analysis
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.
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
Primary outcome measures
- Performance of combined model, retinal, voice and cognitive data [Time frame: Through study completion, an average of 6 months]
- Performance retinal biomarkers [Time frame: Through study completion, an average of 6 months]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07201610 · ps_hsi