Parkinson DiseaseNCT05680571
Validation of Bulbicam for Parkinson- and Ataxia-patients
An observational study of Parkinson Disease and Ataxia, run by Meddoc at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Ataxia
- What is being tested?
- BulbiCam
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 1 siteNorway
- Study dates
- 19 Dec 2022to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Bulbicam for Use on Patient Suffering From Parkinson and Ataxia
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.
Read more
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.
Read the 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:
- 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.
- Conditions
- Parkinson Disease, Ataxia
- Being tested
- BulbiCam
- Medical subject headings
- Parkinson Disease, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: BulbiCam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nystagmus
Frequency in Hz
Measured: 1 hour
Nystagmus
Frequency in Hz
Measured: 2 hours
Nystagmus
Frequency in Hz
Measured: 24 hours
Nystagmus
Frequency in Hz
Measured: 25 hours
Nystagmus
Frequency in Hz
Measured: 36 hours
Nystagmus
Frequency in Hz
Measured: 37 hours
Fixation
Stability in mm
Measured: 1 hour
Fixation
Stability in mm
Measured: 2 hours
Fixation
Stability in mm
Measured: 24 hours
Fixation
Stability in mm
Measured: 25 hours
Fixation
Stability in mm
Measured: 36 hours
Fixation
Stability in mm
Measured: 37 hours
Smooth pursuit 1
Gain velocity in degree
Measured: 1 hour
Smooth pursuit 1
Gain velocity in degree
Measured: 2 hours
Smooth pursuit 1
Gain velocity in degree
Measured: 24 hours
Smooth pursuit 1
Gain velocity in degree
Measured: 25 hours
Smooth pursuit 1
Gain velocity in degree
Measured: 36 hours
Smooth pursuit 1
Gain velocity in degree
Measured: 37 hours
Saccade
Latency in ms
Measured: 1 hour
Saccade
Latency in ms
Measured: 2 hours
Saccade
Latency in ms
Measured: 24 hours
Saccade
Latency in ms
Measured: 25 hours
Saccade
Latency in ms
Measured: 36 hours
Saccade
Latency in ms
Measured: 37 hours
Pupil
Diameter in mm
Measured: 1 hour
Pupil
Diameter in mm
Measured: 2 hours
Pupil
Diameter in mm
Measured: 24 hours
Pupil
Diameter in mm
Measured: 25 hours
Pupil
Diameter in mm
Measured: 36 hours
Pupil
Diameter in mm
Measured: 37 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start19 Dec 2022
- Primary completion28 Feb 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meddoc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Stig Larsen, Meddoc
- Investigators
- Emilia Kerty, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680571
- Sponsor's protocol ID
- V3-NEU/PD; Ataxia-I/2022
- Status last verified
- May 2024
- First submitted
- 1 Jul 2022
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Bulbicam for Use on Patient Suffering From Parkinson and Ataxia
- ClinicalTrials.gov ID
- NCT05680571
- Acronym / sponsor ID
- V3-NEU/PD; Ataxia-I/2022
- Conditions
- Parkinson Disease, Ataxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- MeddocUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson | – | Device: BulbiCamPatients suffering from PD of both genders above 18 years of age and Gender- and age-matched HC without any eye- or neurological disorder. |
| Ataxia | – | Device: BulbiCamPatients suffering from AT of both genders above 18 years of ageand Gender- and age-matched HC without any eye- or neurological disorder. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BulbiCamBulbiCam 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 | Device | Ataxia, Parkinson |
Primary outcome
Nystagmus
Time frame: 1 hour
Frequency in Hz
Nystagmus
Time frame: 2 hours
Frequency in Hz
Nystagmus
Time frame: 24 hours
Frequency in Hz
Nystagmus
Time frame: 25 hours
Frequency in Hz
Nystagmus
Time frame: 36 hours
Frequency in Hz
Nystagmus
Time frame: 37 hours
Frequency in Hz
Fixation
Time frame: 1 hour
Stability in mm
Fixation
Time frame: 2 hours
Stability in mm
Fixation
Time frame: 24 hours
Stability in mm
Fixation
Time frame: 25 hours
Stability in mm
Fixation
Time frame: 36 hours
Stability in mm
Fixation
Time frame: 37 hours
Stability in mm
Smooth pursuit 1
Time frame: 1 hour
Gain velocity in degree
Smooth pursuit 1
Time frame: 2 hours
Gain velocity in degree
Smooth pursuit 1
Time frame: 24 hours
Gain velocity in degree
Smooth pursuit 1
Time frame: 25 hours
Gain velocity in degree
Smooth pursuit 1
Time frame: 36 hours
Gain velocity in degree
Smooth pursuit 1
Time frame: 37 hours
Gain velocity in degree
Saccade
Time frame: 1 hour
Latency in ms
Saccade
Time frame: 2 hours
Latency in ms
Saccade
Time frame: 24 hours
Latency in ms
Saccade
Time frame: 25 hours
Latency in ms
Saccade
Time frame: 36 hours
Latency in ms
Saccade
Time frame: 37 hours
Latency in ms
Pupil
Time frame: 1 hour
Diameter in mm
Pupil
Time frame: 2 hours
Diameter in mm
Pupil
Time frame: 24 hours
Diameter in mm
Pupil
Time frame: 25 hours
Diameter in mm
Pupil
Time frame: 36 hours
Diameter in mm
Pupil
Time frame: 37 hours
Diameter in mm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No. No plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia Kerty, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Ataxia, run by Meddoc at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nystagmus (time frame: 1 hour). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.