NCT05680571

Validation of Bulbicam for Parkinson- and Ataxia-patients

Validation of Bulbicam for Use on Patient Suffering From Parkinson and Ataxia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: Meddoc · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

Aim * To investigate repeatability and stability of four Neurological-related Bulbicam tests in patients suffering from PD, AT and HC. * To contribute to establishment of normal range for PD and AT patients with different degree in the disease development related to the Bulbicam tests. * To contribute to establishment of normal range of these Bulbicam tests for a normal population without neurological or ophthalmological disease. Study population The study consists of the following three study populations: 1) Patients suffering from PD of both genders above 18 years of age; 2) Patients suffering from AT of both genders above 18 years of age; 3) Gender- and age-matched HC without any eye- or neurological disorder. Trial equipment Bulbicam will be used in the study and the following five tests will be performed at each investigation: "Fixation", "Saccade" "Nystagmus", "Smooth pursuit" and "Pupil". Design: 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. Within each of the two basic strata, healthy matched controls related to gender and age (1:1) will be included. No internal classification will be used for PD, but AT will be stratified in: 1. Patients with Nystagmus 2. Patients without Nystagmus For each included patient, a gender- and age-matched HV will be included. The main variables will be the variables recorded at the four Bulbicam tests. The standard neuro-ophthalmological variables included for PD and AT are Nystagmus, Smooth pursuit and Saccade Accurate. Study procedure: 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. All demographic data, social factors and history of disease will be recorded at screening. The general quality of life (QoL) questionnaires EQ-5D-5L developed by EuroQol will be recorded initially as individual baseline values. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for measuring and classifying the tolerability and toxicity at the end of each day of investigation. Sample size: Sixteen PD-patients and 16 AT-patients, equally divided between the internal pairs of strata, will be recruited from the participating hospital. For each included patient, one gender- and age-matched HC will be recruited. In total of 32 HC, 16 PD and 16 AT patients will be included in the study.

Conditions

• Parkinson Disease
• Ataxia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-12-19
• Primary completion: 2023-02-28
• Completion: 2023-03-30
• First posted: 2023-01-11
• Last updated: 2024-05-22

Locations

1 site across 1 country: Norway

Regulatory

• FDA-regulated device study