Skip to main content
OpenTrials
Completed

NCT Number: NCT05680571

Validation of Bulbicam for Parkinson- and Ataxia-patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Ataxia Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0372, Norway

About this study

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:

  • Patients with Nystagmus
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with either PD or AT of both gender; at least the age of 18 years; without any other eye disease; suffering from other know serious disease but have a health situation in accordance with expectations related to the age.
  • gender- and age-matched controls to patients ; passed the age of 18 years without any eye diseases; not suffering from other know serious disease and have a health situation in accordance with expectations related to the age.

Exclusion criteria

  • Other visual disturbances and blindness
  • Posterior Chamber Intraocular Lens (PCIOL)
  • Physical or psychiatric disease, which may disturb the measuring procedure
  • Paresis or paralysis of any oculomotor muscle
  • Patients whose visual acuity is less than 0.1 in any eye, as these will not be able to focus on the test stimuli.
  • Patients whose visible part of the eye is abnormal, such as subconjunctival haemorrhages or deformed pupils
  • Patients whose pupils are not able to respond normally to dilation or contraction due to damaged nerves, mechanical damage of the pupil etc.
  • With known alcoholic and drug dependency
  • Not able to understand information.
  • Not willing to give written consent to participate in the study.

Treatment and study plan

Bulbicam

Device

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

Primary outcomes

  1. Nystagmus

    Time frame: 1 hour

    Frequency in Hz

  2. Nystagmus

    Time frame: 2 hours

    Frequency in Hz

  3. Nystagmus

    Time frame: 24 hours

    Frequency in Hz

  4. Nystagmus

    Time frame: 25 hours

    Frequency in Hz

  5. Nystagmus

    Time frame: 36 hours

    Frequency in Hz

  6. Nystagmus

    Time frame: 37 hours

    Frequency in Hz

  7. Fixation

    Time frame: 1 hour

    Stability in mm

  8. Fixation

    Time frame: 2 hours

    Stability in mm

  9. Fixation

    Time frame: 24 hours

    Stability in mm

  10. Fixation

    Time frame: 25 hours

    Stability in mm

  11. Fixation

    Time frame: 36 hours

    Stability in mm

  12. Fixation

    Time frame: 37 hours

    Stability in mm

  13. Smooth pursuit 1

    Time frame: 1 hour

    Gain velocity in degree

  14. Smooth pursuit 1

    Time frame: 2 hours

    Gain velocity in degree

  15. Smooth pursuit 1

    Time frame: 24 hours

    Gain velocity in degree

  16. Smooth pursuit 1

    Time frame: 25 hours

    Gain velocity in degree

  17. Smooth pursuit 1

    Time frame: 36 hours

    Gain velocity in degree

  18. Smooth pursuit 1

    Time frame: 37 hours

    Gain velocity in degree

  19. Saccade

    Time frame: 1 hour

    Latency in ms

  20. Saccade

    Time frame: 2 hours

    Latency in ms

  21. Saccade

    Time frame: 24 hours

    Latency in ms

  22. Saccade

    Time frame: 25 hours

    Latency in ms

  23. Saccade

    Time frame: 36 hours

    Latency in ms

  24. Saccade

    Time frame: 37 hours

    Latency in ms

  25. Pupil

    Time frame: 1 hour

    Diameter in mm

  26. Pupil

    Time frame: 2 hours

    Diameter in mm

  27. Pupil

    Time frame: 24 hours

    Diameter in mm

  28. Pupil

    Time frame: 25 hours

    Diameter in mm

  29. Pupil

    Time frame: 36 hours

    Diameter in mm

  30. Pupil

    Time frame: 37 hours

    Diameter in mm

Sponsors and collaborators

Lead sponsor

Meddoc

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2023
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.