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Validation of Bulbicam for Parkinson- and Ataxia-patients

NCT05680571 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2024-05-22

No results posted yet for this study

Summary

Aim is to investigate repeatability and stability of four Neurological-related Bulbicam tests in patients suffering Parkinson (PD),Ataxia (AT) and matched healthy control (HC).

Study population The study consists of the patients suffering from PD or AT and HV of both genders above 18 years of age without any eye- or neurological disorder.

Bulbicam will be used in the study and five tests will be performed

The study will be performed as a controlled, open and non-randomized, stratified observational single center. The stratification factors will be pathology (PD\&AT) and internal classifications. ed.

The main variables will be the variables recorded at the four Bulbicam tests and the standard neuro-ophthalmological variables included for PD and AT

Participants, who fulfil the inclusion criteria; do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study. During the first day of the study, the included patients will undergo a neuro-ophthalmological examination by a neurologist. Additionally, Bulbicam examination will be performed twice with a rest period of one hour between each registration.

The healthy controls will only undergo a standard examination and twice BulbiCam examination. The controls will only participate one day. The patients will participate two more days with two Bulbicam examinations per day.

Sample size:

Sixteen PD-patients ,16 AT-patients and 32 HCs will be included in the study.

Conditions

  • Parkinson Disease
  • Ataxia

Interventions

DEVICE

BulbiCam

BulbiCam is an non-invasive, multi-test device which combined eye tracking; pupil metric; video graphic dual device including the f10 tests under development and ready for validation

Sponsors & Collaborators

  • Meddoc

    lead OTHER

Principal Investigators

  • Emilia Kerty, PhD · Oslo University Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-19
Primary Completion
2023-02-28
Completion
2023-03-30
FDA Device
Yes

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05680571 on ClinicalTrials.gov