Validation of Bulbicam for Parkinson- and Ataxia-patients

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05680571
• Other study ID #: V3-NEU/PD; Ataxia-I/2022
• Status: Completed
• Start date: December 19, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: May 2024
• Source: Meddoc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Meddoc

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nystagmus	Frequency in Hz	1 hour
Primary	Nystagmus	Frequency in Hz	2 hours
Primary	Nystagmus	Frequency in Hz	24 hours
Primary	Nystagmus	Frequency in Hz	25 hours
Primary	Nystagmus	Frequency in Hz	36 hours
Primary	Nystagmus	Frequency in Hz	37 hours
Primary	Fixation	Stability in mm	1 hour
Primary	Fixation	Stability in mm	2 hours
Primary	Fixation	Stability in mm	24 hours
Primary	Fixation	Stability in mm	25 hours
Primary	Fixation	Stability in mm	36 hours
Primary	Fixation	Stability in mm	37 hours
Primary	Smooth pursuit 1	Gain velocity in degree	1 hour
Primary	Smooth pursuit 1	Gain velocity in degree	2 hours
Primary	Smooth pursuit 1	Gain velocity in degree	24 hours
Primary	Smooth pursuit 1	Gain velocity in degree	25 hours
Primary	Smooth pursuit 1	Gain velocity in degree	36 hours
Primary	Smooth pursuit 1	Gain velocity in degree	37 hours
Primary	Saccade	Latency in ms	1 hour
Primary	Saccade	Latency in ms	2 hours
Primary	Saccade	Latency in ms	24 hours
Primary	Saccade	Latency in ms	25 hours
Primary	Saccade	Latency in ms	36 hours
Primary	Saccade	Latency in ms	37 hours
Primary	Pupil	Diameter in mm	1 hour
Primary	Pupil	Diameter in mm	2 hours
Primary	Pupil	Diameter in mm	24 hours
Primary	Pupil	Diameter in mm	25 hours
Primary	Pupil	Diameter in mm	36 hours
Primary	Pupil	Diameter in mm	37 hours