Clinical trial NCT06264713: Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Via Eye-tracking Biofeedback
Official title: Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Due to Stroke Via Eye-tracking Biofeedback (IRENE Project): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neglect, Hemispatial
Stroke
Keywords: Neglect
Stroke
Rehabilitation
Virtual Reality
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Clinical Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in the Behavioural Inattention Test
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Secondary outcomes:
measure: Changes in the Copying drawings with or without programming elements
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
measure: Changes in the Barrage Test
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
measure: Changes in the Wundt Justrow area illusion test
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
measure: Changes in the Kessler Foundation Neglect Assessment Process
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
measure: Changes in the Stroke Specific Quality of Life Scale
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
measure: Changes in the Fugl-Meyer Assessment scale
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
measure: Changes in reaction time e time of fixation
timeFrame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS Santa Lucia Foundation
state: Lazio
Study officials:
References:
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