StrokeNCT05309148
Oculomotor and Cognitive Rehabilitation Using Visual Feedback in Stroke Patients
A study testing Training on eye tracker based device, Training with a neuropsychologist and Training on eye tracker based device and with a neuropsychologist in people with Stroke and Oculomotor; Disorder, run by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health at 1 site in Russia.
Trial summary
Investigators will test the effectiveness of oculomotor cognitive training using eye tracker-based device during rehabilitation course in patients with a degree of disability no more than 3 points on a scale Rankin. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Oculomotor; Disorder, Attention Disturbances
- What is being tested?
- Training on eye tracker based device, Training with a neuropsychologist and Training on eye tracker based device and with a neuropsychologist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jan 2022to 20 Dec 2024
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- signed consent
- at least 3 points on the Rankin scale;
- the presence of disorders of the visual-oculomotor system, visual attention;
- understanding and following instructions; stable vegetative and hemodynamic parameters;
- on the MOOCA scale >22;
- patients should be fully examined for the underlying and concomitant disease (examination by a neurologist, ophthalmologist, physiotherapist);
Who cannot join
- 4, 5 points on the Rankin scale;
- unstable hemodynamics;
- time after stroke is less than 2 weeks;
- presence of epileptic activity;
- serious ophthalmological disorders (for example, partial atrophy of the optic nerve);
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
Moscow, 117513
Galina Ivanova, Prof, reabilivanova@mail.ru
Alina Aizenshtein, alinaaiz@yandex.ru
About this study
Official title: Investigation of the Effectiveness of Rehabilitation Equipment Based on Visual Feedback Technology (Eye Tracking) in Patients Who Have Suffered a Cerebral Stroke
Investigators will test the effectiveness of oculomotor cognitive training using eye tracker-based device during rehabilitation course in patients with a degree of disability no more than 3 points on a scale Rankin.
Read the detailed description
After a stroke, a wide range of neurological disorders can occur. One of them is impairments of the visual-oculomotor system in 8-31% of cases. Such patients experience loss of visual fields, hemianopia, tunnel vision, diplopia. All this causes great difficulties for returning to everyday life, as well as to professional activity. The eye tracking method allows to diagnose and evaluate the effectiveness of training aimed at improving the functioning of the saccadic system, reducing the volume of visual deficit. Currently, eye tracking is represented by a variety of technological solutions, but not all of them are used in the clinic.
The aim of the study is the application of an eye tracking-based device in cerebral stroke survivors for the correction of oculomotor disorders and visual attention functions.
Stroke patients participate in the study in Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency, Moscow, Russia. The study has been conducted since January, 10 and was approved by a local ethic committee and followed principles of the Declaration of Helsinki. The patients stay in a 24-hour hospital and undergo a rehabilitation course. For 3 weeks, patients receive daily training on the C-Eye Pro device, AssisTech Sp. z. o. o, Poland. The patients interact with the device only by using eye movements. Participants undergo a primary assessment of cognitive functions (memory, thinking skills, language, visual-spatial and communicative functions). According to the results of the diagnosis, participants are offered a scheme of correctional training and secondary assessment at the end of the training. Correction training consists, firstly, of 10-minute exercise at the beginning of each session, aimed at improving visual functions and attention. Patients have to follow the spontaneously moving object. The result is evaluated qualitatively using heat and scanpath maps. Secondly, the correctional training includes a block of neurorehabilitation (simple cognitive exercises similar to the tasks presented in assessment).
- Conditions
- Stroke, Oculomotor; Disorder, Attention Disturbances
- Being tested
- Training on eye tracker based device, Training with a neuropsychologist, Training on eye tracker based device and with a neuropsychologist
- Keywords
- Eye tracking, Visual feedback, Cognitive functions, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on eye tracker based deviceBehavioural
The intervention is based on the principle of visual biofeedback. The patient sees where his gaze is and can objectively assess and correct his visual error.
Training with a neuropsychologistBehavioural
The intervention is based on classical neuropsychological techniques aimed at correcting oculomotor disorders and improving visual attention (blank, psychometric, etc.)
Training on eye tracker based device and with a neuropsychologistBehavioural
This is combination of the first and second interventions
| Study group | Role | What they receive |
|---|---|---|
| Training on eye tracker based device | Experimental | Patients will undergo a primary diagnostics of cognitive functions (memory, thinking skills, language, visual-spatial and communicative functions) and an diagnostics of the visual attention index on an eye tracker-based device. Based on the results of the diagnosis, participants will be offered a scheme of correctional training and secondary diagnostics at the end of training. Correctional training on an eye tracker-based device consists, firstly, of a 10-minute exercise at the beginning of each lesson aimed at improving visual functions and attention. Patients had to follow a spontaneously moving object. Secondly, correctional training includes a block of neurorehabilitation (simple cognitive exercises similar to the tasks presented in the assessment). Receives: Behavioral: Training on eye tracker based device |
| Training with a neuropsychologist | Active comparator | Patients will undergo primary and secondary diagnostics on an eye tracker-based device, then participants will have a conventional correctional training with a neuropsychologist according to an individual correction plan. Receives: Behavioral: Training with a neuropsychologist |
| Training on eye tracker based device and with a neuropsychologist | Active comparator | Patients will undergo primary and secondary diagnostics and correctional training on an eye tracker-based device, in the same time participants will have a conventional correctional training with a neuropsychologist according to an individual correction plan. Receives: Behavioral: Training on eye tracker based device and with a neuropsychologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consciousness Test
It is necessary to monitor the emerging stimuli (red circles) and keep eyes in the center of each of them. The quantitative indicator of visual attention as a percentage will be measured.
Measured: Change from baseline at 2 weeks
Cognitive function scale: memory scale
Diagnostics of memory functions. Scale is evaluated as a percentage (min - 0%, max - 100%), the higher score means better performance
Measured: Change from baseline at 2 weeks
Cognitive function scale: language scale
Diagnostics of language functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Measured: Change from baseline at 2 weeks
Cognitive function scale: visual-spatial scale
Diagnostics of visual-spatial functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Measured: Change from baseline at 2 weeks
Cognitive function scale: communicative scale
Diagnostics of communicative functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Measured: Change from baseline at 2 weeks
Cognitive function scale: thinking skills scale
Diagnostics of thinking skills functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Measured: Change from baseline at 2 weeks
Assessment of a neuropsychologist
Screening for cognitive impairment: MoCA (Montreal Cognitive Assessment), the results vary between 0 and 30 points. A score of 26 points or more is considered the norm. The lower the score, the worse the result
Measured: Change from baseline at 2 weeks
Assessment of a neuropsychologist
Qualitative assessment of neuropsychological examination data (Luria-Nebraska neuropsychological battery)
Measured: Change from baseline at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start10 Jan 2022
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marina Shurupova, Ph.D., Principal investigator, Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309148
- Sponsor's protocol ID
- Eye001
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Rehabilitation Equipment Based on Visual Feedback Technology (Eye Tracking) in Patients Who Have Suffered a Cerebral Stroke
- ClinicalTrials.gov ID
- NCT05309148
- Acronym / sponsor ID
- Eye001
- Conditions
- Stroke, Oculomotor; Disorder, Attention Disturbances
- Keywords
- Eye tracking, Visual feedback, Cognitive functions, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of HealthUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 4 Apr 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.
Investigators will test the effectiveness of oculomotor cognitive training using eye tracker-based device during rehabilitation course in patients with a degree of disability no more than 3 points on a scale Rankin.
Detailed description
After a stroke, a wide range of neurological disorders can occur. One of them is impairments of the visual-oculomotor system in 8-31% of cases. Such patients experience loss of visual fields, hemianopia, tunnel vision, diplopia. All this causes great difficulties for returning to everyday life, as well as to professional activity. The eye tracking method allows to diagnose and evaluate the effectiveness of training aimed at improving the functioning of the saccadic system, reducing the volume of visual deficit. Currently, eye tracking is represented by a variety of technological solutions, but not all of them are used in the clinic.
The aim of the study is the application of an eye tracking-based device in cerebral stroke survivors for the correction of oculomotor disorders and visual attention functions.
Stroke patients participate in the study in Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency, Moscow, Russia. The study has been conducted since January, 10 and was approved by a local ethic committee and followed principles of the Declaration of Helsinki. The patients stay in a 24-hour hospital and undergo a rehabilitation course. For 3 weeks, patients receive daily training on the C-Eye Pro device, AssisTech Sp. z. o. o, Poland. The patients interact with the device only by using eye movements. Participants undergo a primary assessment of cognitive functions (memory, thinking skills, language, visual-spatial and communicative functions). According to the results of the diagnosis, participants are offered a scheme of correctional training and secondary assessment at the end of the training. Correction training consists, firstly, of 10-minute exercise at the beginning of each session, aimed at improving visual functions and attention. Patients have to follow the spontaneously moving object. The result is evaluated qualitatively using heat and scanpath maps. Secondly, the correctional training includes a block of neurorehabilitation (simple cognitive exercises similar to the tasks presented in assessment).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training on eye tracker based device | Experimental | Behavioral: Training on eye tracker based devicePatients will undergo a primary diagnostics of cognitive functions (memory, thinking skills, language, visual-spatial and communicative functions) and an diagnostics of the visual attention index on an eye tracker-based device. Based on the results of the diagnosis, participants will be offered a scheme of correctional training and secondary diagnostics at the end of training. Correctional training on an eye tracker-based device consists, firstly, of a 10-minute exercise at the beginning of each lesson aimed at improving visual functions and attention. Patients had to follow a spontaneously moving object. Secondly, correctional training includes a block of neurorehabilitation (simple cognitive exercises similar to the tasks presented in the assessment). |
| Training with a neuropsychologist | Active comparator | Behavioral: Training with a neuropsychologistPatients will undergo primary and secondary diagnostics on an eye tracker-based device, then participants will have a conventional correctional training with a neuropsychologist according to an individual correction plan. |
| Training on eye tracker based device and with a neuropsychologist | Active comparator | Behavioral: Training on eye tracker based device and with a neuropsychologistPatients will undergo primary and secondary diagnostics and correctional training on an eye tracker-based device, in the same time participants will have a conventional correctional training with a neuropsychologist according to an individual correction plan. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- signed consent
- at least 3 points on the Rankin scale;
- the presence of disorders of the visual-oculomotor system, visual attention;
- understanding and following instructions; stable vegetative and hemodynamic parameters;
- on the MOOCA scale >22;
Key exclusion criteria (5 listed)
- 4, 5 points on the Rankin scale;
- unstable hemodynamics;
- time after stroke is less than 2 weeks;
- presence of epileptic activity;
- serious ophthalmological disorders (for example, partial atrophy of the optic nerve);
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 |
|---|---|---|
| Training on eye tracker based deviceThe intervention is based on the principle of visual biofeedback. The patient sees where his gaze is and can objectively assess and correct his visual error. | Behavioural | Training on eye tracker based device |
| Training with a neuropsychologistThe intervention is based on classical neuropsychological techniques aimed at correcting oculomotor disorders and improving visual attention (blank, psychometric, etc.) | Behavioural | Training with a neuropsychologist |
| Training on eye tracker based device and with a neuropsychologistThis is combination of the first and second interventions | Behavioural | Training on eye tracker based device and with a neuropsychologist |
Primary outcome
Consciousness Test
Time frame: Change from baseline at 2 weeks
It is necessary to monitor the emerging stimuli (red circles) and keep eyes in the center of each of them. The quantitative indicator of visual attention as a percentage will be measured.
Cognitive function scale: memory scale
Time frame: Change from baseline at 2 weeks
Diagnostics of memory functions. Scale is evaluated as a percentage (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: language scale
Time frame: Change from baseline at 2 weeks
Diagnostics of language functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: visual-spatial scale
Time frame: Change from baseline at 2 weeks
Diagnostics of visual-spatial functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: communicative scale
Time frame: Change from baseline at 2 weeks
Diagnostics of communicative functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Cognitive function scale: thinking skills scale
Time frame: Change from baseline at 2 weeks
Diagnostics of thinking skills functions. Scale is evaluated as a percentage. (min - 0%, max - 100%), the higher score means better performance
Assessment of a neuropsychologist
Time frame: Change from baseline at 2 weeks
Screening for cognitive impairment: MoCA (Montreal Cognitive Assessment), the results vary between 0 and 30 points. A score of 26 points or more is considered the norm. The lower the score, the worse the result
Assessment of a neuropsychologist
Time frame: Change from baseline at 2 weeks
Qualitative assessment of neuropsychological examination data (Luria-Nebraska neuropsychological battery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Marina Shurupova, Ph.D. principal investigator
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training on eye tracker based device, Training with a neuropsychologist and Training on eye tracker based device and with a neuropsychologist in people with Stroke and Oculomotor; Disorder, run by Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health 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 6 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: status not confirmed, as of the sponsor's last update on 4 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Galina Ivanova, Prof (+7(499) 280-35-50, reabilivanova@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consciousness Test (time frame: Change from baseline at 2 weeks). The study lists 8 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 4 Apr 2022.