ClinicalTrials.gg
Not yet recruitingNCT07201610Updated Oct 1, 2025

Non-invasive Diagnosis of Parkinson's Disease

An observational study in Parkinsons Disease (PD), sponsored by Blekinge Institute of Technology. Not yet recruiting. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-01.

Sponsored by Blekinge Institute of Technology · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
60 Years to 80 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • 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
03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 60 is below the median of 96 across 1,085 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Blekinge Institute of Technology is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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 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 ≥ 26 points (out of a maximum of 30) and ≥ 8 points on the clock-drawing test
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

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 months

  2. 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 months

Secondary 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 months

  2. 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 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Anonymised data will be shared upon request from a regarded trustworthy academic partner for replicating purposes only.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07201610
Lead sponsor
Blekinge Institute of Technology
Collaborators
Region Blekinge
Responsible party
Sponsor
First posted
Oct 1, 2025
Start date
Oct 16, 2025 (estimated)
Primary completion
Dec 16, 2025 (estimated)
Completion
Dec 16, 2025 (estimated)
Last update
Oct 1, 2025

Study contacts

Anders Behrens, MD. PhD.
Contact
anders.behrens@bth.se
0046455731000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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