Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Via Eye-tracking Biofeedback (IRENE)

February 21, 2024 updated by: I.R.C.C.S. Fondazione Santa Lucia

Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Due to Stroke Via Eye-tracking Biofeedback (IRENE Project): a Randomized Controlled Trial

The purpose of this study is to evaluate the effects of a treatment using virtual reality on the recovery of unilateral spatial neglect. The investigators hypothesize that the experimental group underwent to a protocol of active exercises within the virtual environment will show an improvement in the exploratory functions of the left hemispace, investigated with specific scales and clinical tests.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebral stroke is the second cause of death and the third cause of disability worldwide, and the first cause of disability in the elderly. One of the most commonly encountered neuropsychological disorders following a stroke is the unilateral spatial neglect. The estimated prevalence of unilateral spatial neglect after stroke is 30%, with a difference in prevalence between subjects with right (38%) and left (18%) lesions. unilateral spatial neglect constitutes a limit in the progression of the patient's rehabilitation, slows down functional recovery and increases stress and burden on the caregiver. In recent decades there has therefore been an appeal to the use of new technologies for the treatment of unilateral spatial neglect. Among these, virtual reality allows us to overcome some limitations of traditional interventions (reduced ecological validity) and has the advantage of using an artificial environment in the virtual space which allows the execution of tasks that simulate the activities of common life. Furthermore, virtual reality systems offer the opportunity to recreate safe, ecological and personalized 3D environments in which patients must perform specific and controlled actions to achieve a goal. Numerous studies have investigated the effectiveness of training with virtual reality showing that it can improve spatial attention in subjects with unilateral spatial neglect and promote the integration of this ability into daily life activities. To date, the studies available in the literature show that through virtual reality treatment it is possible to find significant improvements in the deficit of unilateral spatial neglect.

Specifically, patients undergoing virtual reality training showed an increase in visual perception of the left hemispace and in head movements on the affected side following virtual reality training compared to controls, maintaining the results at the 3-month follow-up. Although encouraging, the data available to date are the result of clinical studies characterized by high heterogeneity, medium methodological value and small sample size. Further investigations are needed to generalize the results. Within virtual environments, performance is measured objectively and the level of difficulty can be adjusted to gradually increase the complexity of the tasks by reducing the support and feedback provided by the therapist. Furthermore, through the immersive virtual reality it is possible to record all the data regarding the actions carried out by the patient within the virtual scenario and this can be used to create performance indices with which to measure, in a quantitative and objective manner, the progress during the rehabilitation process.

Study Type

Interventional

Enrollment (Estimated)

40

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 Locations

  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00142
        • Recruiting
        • IRCCS Santa Lucia Foundation
        • Contact:
          • Valeria Verna, MSc
          • Phone Number: 0651501907
        • Principal Investigator:
          • Valeria Verna, MSc
        • Sub-Investigator:
          • Marco Tramontano, PhD
        • Sub-Investigator:
          • Viviana Betti, PhD
        • Sub-Investigator:
          • Matteo Marucci, PhD
        • Sub-Investigator:
          • Luisa Magnotti, BSc
        • Sub-Investigator:
          • Alessandro Matano, MSc
        • Sub-Investigator:
          • Aurora Tavernese, MSc
        • Sub-Investigator:
          • Paolucci Stefano, MD
        • Sub-Investigator:
          • Alex Martino Cinnera, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ischaemic or hemorrhagic lesion in one hemisphere only (right or left hemiplegia/hemiparesis)
  • Presence of unilateral spatial neglect confirmed by neuropsychological examination
  • Mini Mental State Examination > 23
  • The patient must be able to maintain a sitting position and rotate his head
  • Onset acute event no later than 180 days from the date of enrollment

Exclusion Criteria:

  • Multiple or bilateral lesions
  • Presence of visual difficulties
  • Right neglect with associated aphasic deficit (in comprehension)
  • Mini Mental State Examination < 23
  • Presence of degenerative pathologies, tumors, or other comorbid pathologies
  • Epilepsy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Immersive Virtual Reality
Patients will undergo nine sessions of 20 minutes for three sessions/week, for a total of three weeks of treatment. The training consists of 3 different virtual reality tasks specifically designed for neglect training.
Device: Immersive Virtual Reality
Patients wear a head-mounted-display and will be immersed in a virtual environment. The stimuli will be provided in the left, center and right visual fields. Eye-tracking biofeedback will be provided about the real-time performance during each exercise.
Active Comparator: Sham Immersive Virtual Reality
Patients will undergo nine sessions of 20 minutes for three sessions/week, for a total of three weeks of treatment. The training consists of 3 different virtual reality tasks specifically designed for neglect training.
Device: Sham Immersive Virtual Reality
The patients performed the same protocol of the experimental group, differently to the immersive virtual reality group, from session 2 to session 8 (7 sessions), the stimuli will be provided in the center and right visual fields.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Behavioural Inattention Test
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
The Behavioural Inattention Test (BIT) allows for the assessment of the presence and extent of unilateral spatial neglect through a series of tests comprising "conventional" subtests (paper and pencil tasks) and "behavioural" subtests that reflect aspects of neglect interference during the performance of daily activities. The results of the BIT provide a detailed overview of the presentation of patients with neglect across a wide range of visuo-spatial tasks. The total score resulting from performance on the conventional subtests is considered pathological if it is below the threshold value of 129 (129/146), with lower scores indicating an increased level of impairment.
Baseline, 4 weeks from baseline, 8 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Stroke Specific Quality of Life Scale
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
The Stroke Specific Quality of Life Scale (SSQoL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Total scores range from 49-245 with higher scores indicate better functioning
Baseline, 4 weeks from baseline, 8 weeks from baseline
Changes in the Fugl-Meyer Assessment scale
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment scale. It is designed to assess motor functioning, sensation, balance, joint range of motion and joint pain in patients with post-stroke hemiplegia. Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity. Sensation: ranges from 0 to 24 points. Divided into 8 points for light touch and 16 points for position sense. Balance: ranges from 0 to 14 points. Divided into 6 points for sitting and 8 points for standing. Joint range of motion: ranges from 0 to 44 points. Joint pain: ranges from 0 to 44 points. It determine disease severity, describe motor recovery, and to plan and assess treatment. a score range between 96-99 indicates slight motor discoordination; a score between 85 and 95 indicates hemiparesis; and a score ≤ 84 indicates hemiplegia.
Baseline, 4 weeks from baseline, 8 weeks from baseline
Changes in reaction time e time of fixation
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
The fixation time expressed in percentage and reaction time expressed in millisecond will be recorded via eye-tracking.
Baseline, 4 weeks from baseline, 8 weeks from baseline
Changes in the Copying drawings with or without programming elements
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
The drawing copy test with or without programming elements is used to assess constructive praxis. It comprises three items that the subject must copy freehand or with the assistance of some graphic elements of the model already present on the sheet on which they are copying. The scoring is differentiated: for freehand copying, the range is 0-12, while for copying with programming elements, the range is 0-70. In both cases, lower scores indicate an increased impairment of the function.
Baseline, 4 weeks from baseline, 8 weeks from baseline
Changes in the Barrage Test
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Albert's Test is employed to detect the presence of unilateral spatial neglect in stroke patients. In this test, patients are required to cross out all the lines arranged in random orientations on a sheet of paper (A3 format). The score is determined by the number of segments correctly crossed out, for both the right (10 stimuli) and left (11 stimuli) sides. A difference of 1 omission between the right and left sides is considered pathological.
Baseline, 4 weeks from baseline, 8 weeks from baseline
Changes in the Wundt Justrow area illusion test
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
The Wundt-Jastrow Illusion Test is utilized to assess the presence of unilateral spatial neglect. It employs the Wundt-Jastrow illusion: two sectors of a circle, equal in shape and size, are perceived as different if they are juxtaposed in a way that one of them appears longer. This phenomenon is consistent for all normal subjects but may disappear in the case of neglect. The subject is presented with 40 boards (A3 format), each containing two stimuli, varied in dimensions, convexity orientation (upward or downward), and the position (right or left) of the misaligned margins that induce the illusion. A score is obtained for "expected" responses and one for "unexpected" responses, depending on whether the critical part of the stimulus is on the right or left. A difference greater than 2 between the number of unexpected responses on the right and left indicates neglect.
Baseline, 4 weeks from baseline, 8 weeks from baseline
Changes in the Kessler Foundation Neglect Assessment Process
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
The Kessler Foundation Neglect Assessment Process (KF-NAP™) is used to assess symptoms of spatial neglect in activities of daily living and to assist predicting functional outcomes after a brain damage, such as stroke or traumatic brain injury, in the context of comprehensive clinical evaluation. In addition to the clinical purpose, the KF-NAP™ can be used as an outcome measure in research studies. Behaviours observed in the KF-NAP™ are related to spatial locations in the personal space , the peri-personal space , the extra-personal space, and the mental space. Total scores range from 0 - 30 with higher scores indicating increased disability.
Baseline, 4 weeks from baseline, 8 weeks from baseline

Collaborators and Investigators

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

Sponsor

I.R.C.C.S. Fondazione Santa Lucia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE/2023_041

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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