Virtual Reality Attention Training in Stroke Patients

NCT03458611 | Terminated

• 1 other identifier: VRAT001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

Hemispatial neglect is a post-stroke condition in which patients fail to detect stimuli presented on the side of space opposite to the damaged brain hemisphere (contralesional space). To date, there is no established effective treatment for this condition. A virtual reality (VR) behavioral training for the attention deficits characteristic of patients with hemispatial neglect was developed. Patients are stimulated in the visual and auditory modality to orient towards the contralesional side and are rewarded for detecting targets on this side in this training. In the current study the researchers aim to answer two main questions: 1) how feasible is a VR game-based intervention in stroke patients? and 2) what is the efficacy of the virtual reality game-based intervention in reducing the attention deficits characteristic of hemispatial neglect? To answer these questions a randomized partially double-blind placebo-controlled crossover study will be conducted. Two within-subject conditions will be compared: in the active condition patients will play a VR game in which multisensory stimulation is progressively presented in the neglected region (the location where previously presented targets were missed by the patient) and in the placebo condition patients will play a VR game in which the stimulation is presented in the center of of the VR environment. Neglect symptoms will be measured on a two-daily basis to establish the trend of symptom recovery through time. The hypothesis states that symptoms will recover more quickly when patients receive the active version of the VR intervention compared to the placebo version of the VR intervention.

Conditions

Hemispatial Neglect

Outcome Measures

Primary Outcomes (1)

• Change in the Posner reaction times

  A Posner paradigm is used to measure the primary outcome. Three squares with a size of 1.5°, 2 located at 7° to the left and right of the fixation cross and 1 in the center of the screen are presented. A cue is presented for 100ms. Subsequently, a target is presented 150ms or 1100ms after cue onset for 100ms, in the left or right square (size of 1.4°). Cues and targets appear on the left or right side of the screen with equal probability. The cue can be valid (i.e., same side as target) in 40% of trials, invalid (i.e., opposite to target side) in 40% of trials or not followed by a target in 20% of trials. Patients have to respond as quickly as possible when they see the target. There will be 400 experimental trials that are presented in 4 blocks of 100 trials. The order of the trials is randomized. Our primary outcome measure is the change in the response times on invalid-cued targets for the shortest SOA on the Posner task.

  The primary outcome variable is measured at 8 timepoints: First timepoint = Baseline (pre-intervention), Timepoints 2 until 6 = during intervention, Timepoint 7 = immediately after intervention, Timepoint 8 = 1 week after intervention.

Secondary Outcomes (2)

• Change in the Catherina Bergego Scale (CBS) score

  This outcome variable is measured at 4 time points. Timepoint 1 = Baseline (before intervention), Timepoint 2 = during intervention, Timepoint 3 = Immediately after intervention, Timepoint 4 = 1 week after intervention.

• Change in McIntosh Line Bisection endpoint weighting bias

  This outcome variable is measured at 4 time points. Timepoint 1 = Baseline (before intervention), Timepoint 2 = during intervention, Timepoint 3 = Immediately after intervention, Timepoint 4 = 1 week after intervention.

Study Arms (2)

Group A

EXPERIMENTAL

In period 1 group A will receive the active intervention and in period 2 they will receive the placebo intervention.

Behavioral: Active Intervention; Behavioral: Placebo Intervention

Group B

EXPERIMENTAL

In period 1 group B will receive the placebo intervention and in period 2 they will receive the active intervention.

Behavioral: Active Intervention; Behavioral: Placebo Intervention

Interventions

Active Intervention BEHAVIORAL

An audiovisual expanding (looming) stimulus is presented repeatedly to patients during the intervention (Dent \& Humphreys, 2011). During the game a disk is presented to the player. This disk expands and contracts in size. The presentation of the disk coincides with the presentation of a sound that matches in frequency. The disk predicts the location where the next target will be presented. The player must discriminate between two types of target stimuli that are presented at the center of the disk. To discriminate between the two targets, the player receives a limited time window. The location of the disk and target stimuli are adjusted in real-time as a function of the player's performance. The primary goal of this algorithm is to present the multisensory looming stimuli more frequently in the contralesional field than in the ipsilesional field.

Group A; Group B

Placebo Intervention BEHAVIORAL

The active and placebo intervention are identical in all aspects except for the fact that stimulus presentation will be located in the center of the visual field.

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• They are above 18 years.
• They have had a stroke.

You may not qualify if:

• They or their legal representative are unable to provide informed consent.
• They have a severe comorbid psychiatric (E.g. psychotic symptoms) disorder.
• They have a premorbid neurodegenerative disease (E.g. Alzheimer's dementia, vascular dementia).
• They have severe written language comprehension deficits.
• They have a medical implant, such as a cochlear implant or a pacemaker.
• They have a severe visual or auditory impairment that cannot be corrected for by wearing glasses or a hearing aid while wearing the Oculus Rift headset.
• They are unable to concentrate on a task for more than 15 minutes or are unable to complete a task according to simple task instructions.
• They have a history of epileptic seizures.
• They do not show signs of a spatial asymmetry in performance on a battery of screening tasks.
• The expected discharge of patients is in a period shorter than 7 weeks.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (2)

RevArte

Edegem, Antwerp, 2650, Belgium

Location

University Hospital Leuven Pellenberg

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (11)

• Andersen SW, Millen BA. On the practical application of mixed effects models for repeated measures to clinical trial data. Pharm Stat. 2013 Jan-Feb;12(1):7-16. doi: 10.1002/pst.1548. Epub 2012 Dec 13.

  PMID: 23239585 BACKGROUND

• Azouvi P, Olivier S, de Montety G, Samuel C, Louis-Dreyfus A, Tesio L. Behavioral assessment of unilateral neglect: study of the psychometric properties of the Catherine Bergego Scale. Arch Phys Med Rehabil. 2003 Jan;84(1):51-7. doi: 10.1053/apmr.2003.50062.

  PMID: 12589620 BACKGROUND

• Dent K, Humphreys GW. Neuropsychological evidence for a competitive bias against contracting stimuli. Neurocase. 2011;17(2):112-21. doi: 10.1080/13554794.2010.498381. Epub 2010 Sep 1.

  PMID: 20812139 BACKGROUND

• Green, P., MacLeod, CJ. SIMR: an R package for power analysis of generalized linear mixed models by simulation. Methods in Ecology and Evolution, 7(4): 493-498, 2016.

  BACKGROUND

• Kass, RE., Raftery, AE. Bayes Factors. Journal of the Americal Statistical Association, 90(430): 773-795, 1995.

  BACKGROUND

• Nijboer TC, Kollen BJ, Kwakkel G. Time course of visuospatial neglect early after stroke: a longitudinal cohort study. Cortex. 2013 Sep;49(8):2021-7. doi: 10.1016/j.cortex.2012.11.006. Epub 2012 Dec 19.

  PMID: 23332473 BACKGROUND

• O'Connell RG, Bellgrove MA, Dockree PM, Lau A, Fitzgerald M, Robertson IH. Self-Alert Training: volitional modulation of autonomic arousal improves sustained attention. Neuropsychologia. 2008 Apr;46(5):1379-90. doi: 10.1016/j.neuropsychologia.2007.12.018. Epub 2007 Dec 27.

  PMID: 18249419 BACKGROUND

• Rouder JN, Speckman PL, Sun D, Morey RD, Iverson G. Bayesian t tests for accepting and rejecting the null hypothesis. Psychon Bull Rev. 2009 Apr;16(2):225-37. doi: 10.3758/PBR.16.2.225.

  PMID: 19293088 BACKGROUND

• Schwamm LH, Koroshetz WJ, Sorensen AG, Wang B, Copen WA, Budzik R, Rordorf G, Buonanno FS, Schaefer PW, Gonzalez RG. Time course of lesion development in patients with acute stroke: serial diffusion- and hemodynamic-weighted magnetic resonance imaging. Stroke. 1998 Nov;29(11):2268-76. doi: 10.1161/01.str.29.11.2268.

  PMID: 9804633 BACKGROUND

• Van den Noortgate, W., Onghena, P. Combining Single-Case Experimental Data Using Hierarchical Linear Models. School Psychology Quarterly Fall 2003, 18(3): 325-346, 2003.

  BACKGROUND

• Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.

  PMID: 34196963 DERIVED

MeSH Terms

Conditions

Perceptual Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Céline Gillebert, Prof. Dr.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients are not explicitly explained that a placebo and active version of the intervention will be compared, which makes it more likely for patients not to be aware of the treatment conditions. However they may notice a difference between the two interventions when they switch over from the first to the second intervention condition. In addition, the clinician who will administer the intervention to the patient on a daily basis cannot be blinded to the specific intervention that is administered to the patient, because the clinician will remain present during the intervention to guide the patient through the intervention. However, the clinicians that will perform the evaluation of symptoms using the tasks that are most sensitive to observer bias will be blinded to the treatment condition that is currently applied to the patient to avoid that the measurement of outcome is affected by observer bias.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: The study design is a mix of a within-subject manipulation of the placebo and active intervention conditions and a between-subject manipulation of the order of these two within-subject conditions. To clarify, a placebo and active version of the VR game based attention training will be administered to each patient. The order of these two within-subject conditions is counterbalanced between-subjects to account for differences in order between the two treatment conditions.

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 8, 2018
• Study Start: May 3, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The data will be made available to other researchers upon request.
• Access Criteria: The principal investigator will evaluate a request for sharing of individual participant data. Access criteria to the coded IPD are that the person who requests access has a profession that is associated with professional confidentiality.

Locations

BE (2)