Oculomotor and Cognitive Rehabilitation Using Visual Feedback in Stroke Patients

March 24, 2022 updated by: Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 117513
        • Recruiting
        • Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marina Shurupova, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training on eye tracker based device
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).
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.
Active Comparator: Training with a neuropsychologist
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.
Behavioral: Training with a neuropsychologist
The intervention is based on classical neuropsychological techniques aimed at correcting oculomotor disorders and improving visual attention (blank, psychometric, etc.)
Active Comparator: Training on eye tracker based device and with a neuropsychologist
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.
Behavioral: Training on eye tracker based device and with a neuropsychologist
This is combination of the first and second interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at 2 weeks
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
Change from baseline at 2 weeks
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
Change from baseline at 2 weeks
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
Change from baseline at 2 weeks
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
Change from baseline at 2 weeks
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
Change from baseline at 2 weeks
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
Change from baseline at 2 weeks
Assessment of a neuropsychologist
Time Frame: Change from baseline at 2 weeks
Qualitative assessment of neuropsychological examination data (Luria-Nebraska neuropsychological battery)
Change from baseline at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Marina Shurupova, Ph.D., Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Anticipated)

December 20, 2022

Study Completion (Anticipated)

December 20, 2024

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eye001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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