Oculomotor and Cognitive Rehabilitation Using Visual Feedback in Stroke Patients

Stroke Clinical Trial

Official title:

Investigation of the Effectiveness of Rehabilitation Equipment Based on Visual Feedback Technology (Eye Tracking) in Patients Who Have Suffered a Cerebral Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05309148
• Other study ID #: Eye001
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: March 2022
• Source: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
• Contact: Galina Ivanova, Prof
• Phone: +7(499) 280-35-50
• Email: reabilivanova[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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);

Exclusion Criteria:

• 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);

Related Conditions & MeSH terms

• Attention Disturbances
• Oculomotor; Disorder
• Stroke

Intervention

Behavioral:
• Training on eye tracker based device
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 neuropsychologist
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 neuropsychologist
This is combination of the first and second interventions

Locations

Country	Name	City	State
Russian Federation	Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline at 2 weeks
Primary	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	Change from baseline at 2 weeks
Primary	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	Change from baseline at 2 weeks
Primary	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	Change from baseline at 2 weeks
Primary	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	Change from baseline at 2 weeks
Primary	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	Change from baseline at 2 weeks
Primary	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	Change from baseline at 2 weeks
Primary	Assessment of a neuropsychologist	Qualitative assessment of neuropsychological examination data (Luria-Nebraska neuropsychological battery)	Change from baseline at 2 weeks