NCT05309148

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

March 15, 2022

Last Update Submit

March 24, 2022

Conditions

StrokeOculomotor; DisorderAttention Disturbances

Keywords

Eye trackingVisual feedbackCognitive functionsRehabilitation

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Assessment of a neuropsychologist

    Qualitative assessment of neuropsychological examination data (Luria-Nebraska neuropsychological battery)

    Change from baseline at 2 weeks

Study Arms (3)

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).

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.

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.

Behavioral: Training on eye tracker based device and with a neuropsychologist

Interventions

Training on eye tracker based deviceBEHAVIORAL

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 on eye tracker based device
Training with a neuropsychologistBEHAVIORAL

The intervention is based on classical neuropsychological techniques aimed at correcting oculomotor disorders and improving visual attention (blank, psychometric, etc.)

Training with a neuropsychologist
Training on eye tracker based device and with a neuropsychologistBEHAVIORAL

This is combination of the first and second interventions

Training on eye tracker based device and with a neuropsychologist

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • , 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency

Moscow, 117513, Russia

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Marina Shurupova, Ph.D.

    Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Galina Ivanova, Prof

CONTACT

+7(499) 280-35-50reabilivanova@mail.ru

Alina Aizenshtein

CONTACT

+79104082769alinaaiz@yandex.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2022

First Posted

April 4, 2022

Study Start

January 10, 2022

Primary Completion

December 20, 2022

Study Completion

December 20, 2024

Last Updated

April 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)