NCT05680571

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

December 19, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

July 1, 2022

Last Update Submit

May 21, 2024

Conditions

Parkinson DiseaseAtaxia

Outcome Measures

Primary Outcomes (30)

  • Nystagmus

    Frequency in Hz

    1 hour

  • Nystagmus

    Frequency in Hz

    2 hours

  • Nystagmus

    Frequency in Hz

    24 hours

  • Nystagmus

    Frequency in Hz

    25 hours

  • Nystagmus

    Frequency in Hz

    36 hours

  • Nystagmus

    Frequency in Hz

    37 hours

  • Fixation

    Stability in mm

    1 hour

  • Fixation

    Stability in mm

    2 hours

  • Fixation

    Stability in mm

    24 hours

  • Fixation

    Stability in mm

    25 hours

  • Fixation

    Stability in mm

    36 hours

  • Fixation

    Stability in mm

    37 hours

  • Smooth pursuit 1

    Gain velocity in degree

    1 hour

  • Smooth pursuit 1

    Gain velocity in degree

    2 hours

  • Smooth pursuit 1

    Gain velocity in degree

    24 hours

  • Smooth pursuit 1

    Gain velocity in degree

    25 hours

  • Smooth pursuit 1

    Gain velocity in degree

    36 hours

  • Smooth pursuit 1

    Gain velocity in degree

    37 hours

  • Saccade

    Latency in ms

    1 hour

  • Saccade

    Latency in ms

    2 hours

  • Saccade

    Latency in ms

    24 hours

  • Saccade

    Latency in ms

    25 hours

  • Saccade

    Latency in ms

    36 hours

  • Saccade

    Latency in ms

    37 hours

  • Pupil

    Diameter in mm

    1 hour

  • Pupil

    Diameter in mm

    2 hours

  • Pupil

    Diameter in mm

    24 hours

  • Pupil

    Diameter in mm

    25 hours

  • Pupil

    Diameter in mm

    36 hours

  • Pupil

    Diameter in mm

    37 hours

Study Arms (2)

Parkinson

Patients suffering from PD of both genders above 18 years of age and Gender- and age-matched HC without any eye- or neurological disorder.

Device: BulbiCam

Ataxia

Patients suffering from AT of both genders above 18 years of ageand Gender- and age-matched HC without any eye- or neurological disorder.

Device: BulbiCam

Interventions

BulbiCamDEVICE

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

AtaxiaParkinson

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of PD and AT-patients of both gender; past the age of 18 years; without any other eye disease and suffering from other know serious disease, but have a health situation in accordance with expectations related to the age.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0372, Norway

Location

MeSH Terms

Conditions

Parkinson DiseaseAtaxia

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emilia Kerty, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2022

First Posted

January 11, 2023

Study Start

December 19, 2022

Primary Completion

February 28, 2023

Study Completion

March 30, 2023

Last Updated

May 22, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

No plan

Locations

NO(1)