Non-invasive Diagnosis of Parkinson's Disease
ConditionParkinsons Disease (PD)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-80
SponsorBlekinge Institute of Technology
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Parkinson disease
Group B: Healthy controls
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
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 months2
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 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Blekinge Institute of Technology
Lead sponsor
Region Blekinge
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: