Non-invasive Diagnosis of Parkinson's Disease

NCT07201610 | Not Yet Recruiting

• 1 other identifier: ps_hsi
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Through study completion, an average of 6 months

Secondary Outcomes (2)

• Diagnostic performance of each modality on its own.

  Through study completion, an average of 6 months

• Correlational analyses

  Through study completion, an average of 6 months

Study Arms (2)

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

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blekinge Institute of Technology: lead
• Region Blekinge: collaborator

MeSH Terms

Conditions

Parkinson Disease; Lewy Body Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Anders Behrens, MD. PhD.

CONTACT

0046455731000; anders.behrens@bth.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 1, 2025
• Study Start: October 16, 2025
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication
• Access Criteria: Anonymised data will be shared upon request from a regarded trustworthy academic partner for replicating purposes only.