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

NCT06264713 | Unknown

• 1 other identifier: CE/2023_041
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neglect, Hemispatial; Stroke

Keywords

Neglect; Stroke; Rehabilitation; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Changes in the Behavioural Inattention Test

  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 Outcomes (7)

• Changes in the Copying drawings with or without programming elements

  Baseline, 4 weeks from baseline, 8 weeks from baseline

• Changes in the Barrage Test

  Baseline, 4 weeks from baseline, 8 weeks from baseline

• Changes in the Wundt Justrow area illusion test

  Baseline, 4 weeks from baseline, 8 weeks from baseline

• Changes in the Kessler Foundation Neglect Assessment Process

  Baseline, 4 weeks from baseline, 8 weeks from baseline

• Changes in the Stroke Specific Quality of Life Scale

  Baseline, 4 weeks from baseline, 8 weeks from baseline

Study Arms (2)

Experimental Immersive Virtual Reality

EXPERIMENTAL

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

Sham Immersive Virtual Reality

ACTIVE COMPARATOR

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

Interventions

Immersive Virtual Reality 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.

Experimental Immersive Virtual Reality

Sham Immersive Virtual Reality 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.

Sham Immersive Virtual Reality

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

IRCCS Santa Lucia Foundation

Rome, Lazio, 00142, Italy

RECRUITING

Related Publications (12)

• Esposito E, Shekhtman G, Chen P. Prevalence of spatial neglect post-stroke: A systematic review. Ann Phys Rehabil Med. 2021 Sep;64(5):101459. doi: 10.1016/j.rehab.2020.10.010. Epub 2021 Sep 24.

  PMID: 33246185 RESULT

• Navarro MD, Llorens R, Noe E, Ferri J, Alcaniz M. Validation of a low-cost virtual reality system for training street-crossing. A comparative study in healthy, neglected and non-neglected stroke individuals. Neuropsychol Rehabil. 2013;23(4):597-618. doi: 10.1080/09602011.2013.806269. Epub 2013 Jun 14.

  PMID: 23767963 RESULT

• De Luca R, Lo Buono V, Leo A, Russo M, Aragona B, Leonardi S, Buda A, Naro A, Calabro RS. Use of virtual reality in improving poststroke neglect: Promising neuropsychological and neurophysiological findings from a case study. Appl Neuropsychol Adult. 2019 Jan-Feb;26(1):96-100. doi: 10.1080/23279095.2017.1363040. Epub 2017 Sep 22.

  PMID: 28937807 RESULT

• Yasuda K, Kato R, Sabu R, Kawaguchi S, Iwata H. Development and proof of concept of an immersive virtual reality system to evaluate near and far space neglect in individuals after stroke: A brief report. NeuroRehabilitation. 2020;46(4):595-601. doi: 10.3233/NRE-203014.

  PMID: 32508332 RESULT

• Choi HS, Shin WS, Bang DH. Application of digital practice to improve head movement, visual perception and activities of daily living for subacute stroke patients with unilateral spatial neglect: Preliminary results of a single-blinded, randomized controlled trial. Medicine (Baltimore). 2021 Feb 12;100(6):e24637. doi: 10.1097/MD.0000000000024637.

  PMID: 33578583 RESULT

• Heyse J, Carlier S, Verhelst E, Vander Linden C, De Backere F, De Turck F. From Patient to Musician: A Multi-Sensory Virtual Reality Rehabilitation Tool for Spatial Neglect. Applied Sciences. 2022; 12(3):1242. https://doi.org/10.3390/app12031242

  RESULT

• Smith J, Hebert D, Reid D. Exploring the effects of virtual reality on unilateral neglect caused by stroke: Four case studies. Technol. Disabil. 2007;19:29-40. doi: 10.3233/TAD-2007-19104.

  RESULT

• Kim J, Kim K, Kim DY, Chang WH, Park CI, Ohn SH, Han K, Ku J, Nam SW, Kim IY, Kim SI. Virtual environment training system for rehabilitation of stroke patients with unilateral neglect: crossing the virtual street. Cyberpsychol Behav. 2007 Feb;10(1):7-15. doi: 10.1089/cpb.2006.9998.

  PMID: 17305443 RESULT

• Ogourtsova T, Souza Silva W, Archambault PS, Lamontagne A. Virtual reality treatment and assessments for post-stroke unilateral spatial neglect: A systematic literature review. Neuropsychol Rehabil. 2017 Apr;27(3):409-454. doi: 10.1080/09602011.2015.1113187. Epub 2015 Dec 1.

  PMID: 26620135 RESULT

• Martino Cinnera A, Bisirri A, Chioccia I, Leone E, Ciancarelli I, Iosa M, Morone G, Verna V. Exploring the Potential of Immersive Virtual Reality in the Treatment of Unilateral Spatial Neglect Due to Stroke: A Comprehensive Systematic Review. Brain Sci. 2022 Nov 20;12(11):1589. doi: 10.3390/brainsci12111589.

  PMID: 36421913 RESULT

• Katz N, Ring H, Naveh Y, Kizony R, Feintuch U, Weiss PL. Interactive virtual environment training for safe street crossing of right hemisphere stroke patients with unilateral spatial neglect. Disabil Rehabil. 2005 Oct 30;27(20):1235-43. doi: 10.1080/09638280500076079.

  PMID: 16298925 RESULT

• Pedroli E, Serino S, Cipresso P, Pallavicini F, Riva G. Assessment and rehabilitation of neglect using virtual reality: a systematic review. Front Behav Neurosci. 2015 Aug 25;9:226. doi: 10.3389/fnbeh.2015.00226. eCollection 2015.

  PMID: 26379519 RESULT

MeSH Terms

Conditions

Perceptual Disorders; Stroke

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Valeria Verna, MSc

CONTACT

0651501907; v.verna@hsantalucia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind randomisation. The patients and their families/caregivers are blinded with respect to the group allocation. The assessors are not informed about the group allocation for the entire period of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Clinical Trial

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 22, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)