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

NCT ID: NCT06264713

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-12-01

Brief Summary

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.

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.

Conditions

Neglect, Hemispatial; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Immersive Virtual Reality

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Sham Immersive Virtual Reality

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Santa Lucia Foundation

Rome, Lazio, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Valeria Verna, MSc

Role: CONTACT

v.verna@hsantalucia.it

0651501907

Facility Contacts

Valeria Verna, MSc

Role: primary

0651501907

References

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Other Identifiers

CE/2023_041

Identifier Type: -

Identifier Source: org_study_id