Non-invasive Diagnosis of Parkinson's Disease

NCT ID: NCT07201610

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-16
• Study Completion Date: 2025-12-16

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

Conditions

Parkinsons Disease (PD)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Region Blekinge

UNKNOWN

Sponsor Role: collaborator

Blekinge Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Anders Behrens, MD. PhD.

Role: CONTACT

anders.behrens@bth.se

0046455731000

Other Identifiers

ps_hsi

Identifier Type: -

Identifier Source: org_study_id