Ataxia TelangiectasiaNCT05471310
Videoocular Assessment of Eye Movement Activity in an Ataxia Telangiectasia
An observational study of Ataxia Telangiectasia and Dysmetria, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
Trial summary
Ataxia-telangiectasia (A-T) is a multisystem auto-somal recessive disorder linked to the A-T mutated gene (ATM) on chromosome 11q22-23, and characterized by progressive neural degeneration, immunodeficiency, and progressive ocular motor dysfunction. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Ataxia Telangiectasia, Dysmetria
- How many people
- 5 participants
- Where
- 1 siteRussia
- Study dates
- 15 Mar 2021to 30 Jun 2022
- 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 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The young citizens of Russia suffered from ataxia telangiectasia.
Who may be able to join
- confirmed diagnosis of ataxia telangiectasia,
- informed consent,
- stay at the Clinical Research Rehabilitation Center "Russkoe Pole" for 14 days.
Who cannot join
- epilepsy,
- poor visual acuity, inability to percept from a computer monitor,
- inability to hold head and posture satisfactory to perform the tasks,
- difficulty to obtain adequate recordings due to corrective lenses,
- visual field defects.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Clinical Rehabilitation Research Center "Russkoe pole"
Chekhov, 142321
About this study
Official title: Eye-tacking Method as a Diagnostic Tool for Assessment of Oculomotor Parameters (Gaze-holding Score, Scan Path, Visually Guided Saccades Etc) in Pediatric Patients With Ataxia Telangiectasia
Ataxia-telangiectasia (A-T) is a multisystem auto-somal recessive disorder linked to the A-T mutated gene (ATM) on chromosome 11q22-23, and characterized by progressive neural degeneration, immunodeficiency, and progressive ocular motor dysfunction. In previous studies, the quantitative description of the ocular motor deficits from clinical examination was limited to various defects in saccade and gaze control, dysmetric saccades, impairments of smooth pursuit, gaze holding, convergence, vestibular and optokinetic nystagmus slow phases, and cancellation of the vestibulo-ocular reflex. The aim of our research is to add existing findings with quantitative description of oculomotor patterns in A-T patients using videooculography (VOG).
- Conditions
- Ataxia Telangiectasia, Dysmetria
- Keywords
- Eye movements, Saccades, Unstable gaze holding, Rehabilitation
- Medical subject headings
- Ataxia Telangiectasia, Cerebellar Ataxia
What is being measured
The primary outcome is the main question the study is designed to answer.
Gaze holding task
A fixation task in which the subject will require to look at a target-a green circle (diameter ~1) sequentially presented at eccentric (15 rightward and leftward, 8 upward and downward) positions, each eccentric position being sustained for 20 s. Gaze-holding score will be assessed for each circle by approximating the gaze position coordinates by the least squares method to obtain the best correspondence using the fit function. The areas of the obtained ellipses, reflecting the spread of gaze position coordinates, will be determined for each of the four circle positions in each subject. Areas will be expressed in square visual degrees (sq. deg.)
Measured: baseline, during the intervention-rehabilitation course (once)
Visual search task
Ten black circles (diameter ~1) will be presented on the monitor distributed pseudorandomly over the screen. Subjects will be instructed to count silently the number of points and give a verbal response. Study parameters: the performance time, the number of fixations, their durations, the total length of the scanning trajectory, and the saccade amplitude.
Measured: baseline, during the intervention-rehabilitation course (once)
Visually guided saccade task
The subject will be required to follow a target jumping their gaze from one corner of the square to the next as quickly as possible as soon as a circle appeared; saccades will be required in order to do this (An image of a square with side length 10° will be presented on the monitor and a red circle (diameter ~1°) appeared in the corners sequentially in the clockwise direction.) Study parameters: the total number of saccades completed, the proportions of relatively accurate (A in the range 8.5-11.5°), hypometric (short, A < 8.5°), and hypermetric (long, A > 11.5°), and corrective saccades (occurring only after dysmetric saccades, 1.5° < A < 5°);
Measured: baseline, during the intervention-rehabilitation course (once)
Secondary outcomes (1)
Scale for the assessment and rating of ataxia
A clinical scale that is based on a semi-quantitative assessment of cerebellar ataxia on an impairment level.
Measured: baseline, during the intervention-rehabilitation course (once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start15 Mar 2021
- Primary completion31 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ataxia TelangiectasiaStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander F. Karelin, PhD, Study director, Clinical Rehabilitation Research Center "Russkoe pole"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471310
- Sponsor's protocol ID
- LB_03/17/22
- Status last verified
- Jul 2022
- First submitted
- 7 Apr 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye-tacking Method as a Diagnostic Tool for Assessment of Oculomotor Parameters (Gaze-holding Score, Scan Path, Visually Guided Saccades Etc) in Pediatric Patients With Ataxia Telangiectasia
- ClinicalTrials.gov ID
- NCT05471310
- Acronym / sponsor ID
- LB_03/17/22
- Conditions
- Ataxia Telangiectasia, Dysmetria
- Keywords
- Eye movements, Saccades, Unstable gaze holding, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 22 Jul 2022 (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.
Ataxia-telangiectasia (A-T) is a multisystem auto-somal recessive disorder linked to the A-T mutated gene (ATM) on chromosome 11q22-23, and characterized by progressive neural degeneration, immunodeficiency, and progressive ocular motor dysfunction. In previous studies, the quantitative description of the ocular motor deficits from clinical examination was limited to various defects in saccade and gaze control, dysmetric saccades, impairments of smooth pursuit, gaze holding, convergence, vestibular and optokinetic nystagmus slow phases, and cancellation of the vestibulo-ocular reflex. The aim of our research is to add existing findings with quantitative description of oculomotor patterns in A-T patients using videooculography (VOG).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The young citizens of Russia suffered from ataxia telangiectasia.
Key inclusion criteria (3 listed)
- confirmed diagnosis of ataxia telangiectasia,
- informed consent,
- stay at the Clinical Research Rehabilitation Center "Russkoe Pole" for 14 days.
Key exclusion criteria (5 listed)
- epilepsy,
- poor visual acuity, inability to percept from a computer monitor,
- inability to hold head and posture satisfactory to perform the tasks,
- difficulty to obtain adequate recordings due to corrective lenses,
- visual field defects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gaze holding task
Time frame: baseline, during the intervention-rehabilitation course (once)
A fixation task in which the subject will require to look at a target-a green circle (diameter ~1) sequentially presented at eccentric (15 rightward and leftward, 8 upward and downward) positions, each eccentric position being sustained for 20 s. Gaze-holding score will be assessed for each circle by approximating the gaze position coordinates by the least squares method to obtain the best correspondence using the fit function. The areas of the obtained ellipses, reflecting the spread of gaze position coordinates, will be determined for each of the four circle positions in each subject. Areas will be expressed in square visual degrees (sq. deg.)
Visual search task
Time frame: baseline, during the intervention-rehabilitation course (once)
Ten black circles (diameter ~1) will be presented on the monitor distributed pseudorandomly over the screen. Subjects will be instructed to count silently the number of points and give a verbal response. Study parameters: the performance time, the number of fixations, their durations, the total length of the scanning trajectory, and the saccade amplitude.
Visually guided saccade task
Time frame: baseline, during the intervention-rehabilitation course (once)
The subject will be required to follow a target jumping their gaze from one corner of the square to the next as quickly as possible as soon as a circle appeared; saccades will be required in order to do this (An image of a square with side length 10° will be presented on the monitor and a red circle (diameter ~1°) appeared in the corners sequentially in the clockwise direction.) Study parameters: the total number of saccades completed, the proportions of relatively accurate (A in the range 8.5-11.5°), hypometric (short, A < 8.5°), and hypermetric (long, A > 11.5°), and corrective saccades (occurring only after dysmetric saccades, 1.5° < A < 5°);
1 secondary outcome
Scale for the assessment and rating of ataxia
Time frame: baseline, during the intervention-rehabilitation course (once)
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 Jul 2022.
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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.
Alexander F. Karelin, PhD study director
Clinical Rehabilitation Research Center "Russkoe pole"
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 Ataxia Telangiectasia and Dysmetria, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
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 3 inclusion and 5 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 Jul 2022. 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 Russia. 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?
Gaze holding task (time frame: baseline, during the intervention-rehabilitation course (once)). The study lists 3 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 Jul 2022.