Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-29
Brief Title:
Visual Telerehabilitation in Children Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Effectiveness of a Visual Telerehabilitation Program on Visual Perception in Children Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HHREHAB
Brief Summary:
Brain malignancies are the most common cause of death from cancer in the pediatric population and a major source of morbidity amongst survivors Many children with a brain tumour often suffer from visual field defects hemianopia dramatically impacting their daily life with poorer social interaction difficulties learning playing sports and engaging with peers Practically they bump into people and objects and have problems in finding their way in unfamiliar places and in detecting incoming objects in their blind field There is growing recognition of the diverse and deep impact of hemianopia on physical and mental health quality of life and social outcomes of the affected individuals and their family However despite the frequent impact of brain tumours on the visual function and functional vision ophthalmologic evaluations are not standard of care for all brain tumour patients and there are no standardized protocols of vision loss management in the pediatric population with hemianopia There is an unmet need of restoring perception in the blind field in individuals with hemianopia consecutive to pediatric brain tumor
Our laboratory has developed a visual rehabilitation procedure based on the combination of adaptative audio and visual target tracking in a 3D environment in virtual reality Participants perform audiovisual stimulation at home in a headset with remote control from the laboratory Preliminary on data on paediatric patients with hemianopia consecutive to a brain tumour indicate feasibility and potential effectiveness of a 6-week ReVision program on visual fields visual perception and quality of life
Our objective is to evaluate the effectiveness of ReVision an 8-week visual telerehabilitation program on visual perception in 50 individuals aged 10-40 years old with hemianopia consecutive to a pediatric brain tumor in a phase IIab multi-centric clinical study across Canada
This intervention provides more equitable access to individuals with the ability to receive rehabilitation therapy at home without supervision by a healthcare professional meaning that Canadians living outside urban centres could take advantage of specialized therapies with remote supervision This is the first study that could lead to a major change in the management of these patients It could open the door for visual rehabilitation strategies to other population of visually impaired children significantly impacting public health strategies
Our laboratory has developed a visual rehabilitation procedure based on the combination of adaptative audio and visual target tracking in a 3D environment in virtual reality Participants perform audiovisual stimulation at home in a headset with remote control from the laboratory Preliminary on data on paediatric patients with hemianopia consecutive to a brain tumour indicate feasibility and potential effectiveness of a 6-week ReVision program on visual fields visual perception and quality of life
Our objective is to evaluate the effectiveness of ReVision an 8-week visual telerehabilitation program on visual perception in 50 individuals aged 10-40 years old with hemianopia consecutive to a pediatric brain tumor in a phase IIab multi-centric clinical study across Canada
This intervention provides more equitable access to individuals with the ability to receive rehabilitation therapy at home without supervision by a healthcare professional meaning that Canadians living outside urban centres could take advantage of specialized therapies with remote supervision This is the first study that could lead to a major change in the management of these patients It could open the door for visual rehabilitation strategies to other population of visually impaired children significantly impacting public health strategies
Detailed Description:
Central nervous system tumors are the second most common malignancies in childhood A brain tumor and its treatment can affect the visual system at different levels from the optic nerves through compression or infiltration to sub-cortical structures such as the superior colliculus SC and lateral geniculate nuclei LGN to optic tracts optic radiations and visual cortices Children with brain tumors can present visual impairments like decreased visual acuity and contrast sensitivity loss of color vision and visual field loss such as hemianopsias Individuals with hemianopsia present difficulties in detecting stimuli in the defective visual field and show defective scanning and exploration Moreover they show a rotation and compression of the auditory space leading to imprecise localization of sound across both hemispaces Hemianopsia patients naturally develop oculo-3D-MOTor strategies to compensate for visual field loss but visual rehabilitation procedure must still be developed to optimizeimprove visual perception in the blind field Several studies demonstrated that individuals with hemianopsia could improve visual perception in the damaged hemifield after a stimulation procedure where auditory and visual stimuli were temporally and spatially correlated Such repetitive audiovisual stimulation programs induce a functional and anatomical reorganization of the visual connectivity in sub-cortical and cortical structures over time mediated by perceptual learning and synaptic plasticity
The investigators have developed an audiovisual stimulation procedure using immersive virtual reality IVR in head-mounted display HMD as a delivery platform IVR is an emerging and very promising approach for visual and auditory rehabilitation There are currently limited practical results whether this technology is suitable for low-vision patients to use at home and if it can be deployed on a large scale A few case reportseries studies suggested a potential effectiveness of IVR on visual perception in teenagers and young adults but more information as to the potential of use and effectiveness of this technology is necessary
Real-time measurement of task performance and neurophysiological signals while immersed in virtual reality can bring many benefits from monitoring experience-related factors to the development of bioneuromarkers In Multiple Object Tracking in 3D 3D-MOT visual tracking and detection is directly influenced by the speed of the spheres and is tailored to the participants performance using an adapted design to efficiently reach perceptual threshold therefore constantly challenging the patients perceptual abilities Progress made by the participants can be evaluated following real-time measures such as speed of the spheres percentage of positive hits and reaction time These outcomes naturally increase over sessions as a learning effect generally around 5-6 sessions in our settings but then quickly stabilize Further progress of performance is related to improvement in vision as a strong correlation between performance at 3D-MOT and functional vision outcomes is observed in our pilot studies
Eye-tracking measures eye position and movement using pupil position to infer fixation gaze durations saccadic velocities and saccadic amplitudes which altogether reveal strategies that lead to successful detection and tracking Eye-tracking has been extensively used during the 3D-MOT task to describe the strategies of attention allocation during visual tracking Targetheadeye-tracking measures positions recorded every 14 ms - 90Hz will be used to investigate the visual strategies head movement saccades fixation smooth pursuit developed by the participants to track the targets in 3D-MOT
Visual field recovery and restoration from hemianopsia has been postulated to occur from both improved function of perilesional tissue and recruitment of additional cortical structures to assume the function of the permanently damaged centers However longitudinal studies detailing functional and structural changes in the visual system before and after treatment are lacking EEG recordings in individuals with hemianopsia revealed some residual activity in V1 Here brain activity in V1 will be measured before and after treatment and in comparison between control and treated group using visually evoked potential VEP Retinal anatomy changes will be investigated between control and treated group by measuring the ganglion cell complex GCC integrity and the retinal nerve fiber layer RNFL thickness indicative of retinal ganglion cell atrophy using spectral domain optic coherence tomography SD-OCT a non-invasive imaging technique Brain scans Diffusion MRI Retinotopy will be performed using a 3T MRI at the Toronto site Advanced MRI Toronto Western Hospital University Health Network to visualize the integrity optic radiation and activity primary visual cortex of the visual system between control and treated group
Hypothesis Home-based audiovisual 3D-MOT IVR stimulation program will improve visual perception primary outcome Esterman binocular field test 3 points perceived in the blind field of individuals with hemianopsia and increase contrast sensitivity fixation stability reading speed and quality of life secondary outcomes
Following the ORBIT model a phase IIab single blind to assessor prospective randomized controlled multi-centre cross-over study involving 5 academic centres in Canada St Justine - Montreal CHUL - Quebec Alberta Childrens Hospital - Calgary BC Childrens Hospital - Vancouver and Hospital for Sick Children - Toronto will be performed Participants will be randomized into 2 groups Group 1 receives no treatment for the first 8 weeks and then start the 3D-MOT IVR program Group 2 starts with 3D-MOT IVR and then switches to an observation period for 8 weeks Using this cross-over design outcome measures at week 8 W8 - Period 1 will assess the effectiveness of 3D-MOT stimulation between the control non-treated G 1 and treated G 2 groups independent measures Primary outcomes assessment at week 16 W16 - Period 2 will measure the effectiveness of 3D-MOT IVR within Group 1 internal control repeated measures and the sustainability of the treatment in Group 2 repeated measures Visual assessments will be performed at baseline 8 and 16 weeks with follow-ups at 20 and 40 weeks W21 W42
Population
Male and female individuals aged 10 - 40 years old diagnosed with hemianopsia consecutive to a brain tumour with no prior visual rehabilitation interventions
Intervention
3D-MOT in immersive virtual reality
1 session every 2 days 1 day for 8 weeks 28 sessions total
1 session 3 blocks of 15 audiovisual stimulation tasks 2 min break between each block
1 task 20 seconds audiovisual IVR stimulation 3D-MOT correlated sound Rest time is 30 sec to 2 min between blocks 1 session lasts 19 min The duration of subjects participation is 8 months including follow-up Treatment period 8 weeks Follow-up period 6 months The expected frequency and duration of study visits anticipated time commitment for study participants Screeninginclusion visit 2-3 hours visit 1 Period change visit 15 hours visit 2 Final visit 2 hours visit 3 Follow-up visit 1 month 15 hours visit 4 Follow-up visit 6 months 15 hours visit 5
Primary outcome the Esterman binocular field testing will be performed at the ophthalmology clinic of the participating centers at baseline week 8 week 16 and follow-up at week 21 and week 42
There are no risks for participants enrolled in the study The use of IVR may cause moderate dizziness nausea or disorientation for continuous stimulation above 10 minutes If nausea dizziness or disorientation is experienced during IVR stimulation stopping the VR stimulation immediately restores normal condition
Participants will be assessed for IVR sensitivity using the Virtual reality Induced Symptoms and Effects VRISE questionnaire score at inclusion exclusion criteria three 3 consecutive VRISE score 25 At-home continuous VR stimulation will be 5 minutes of continuous stimulation below the critical 10 minutes threshold inducing effects and symptoms
Bias minimization
Selection bias will be addressed by randomly assigning participants to treatment or reference group using a permuted block randomization approach block size 2
Attrition bias will be addressed by including all participants who were randomized into the study intention-to-treat analysis
Performance and detection biases will be partially controlled for as primary outcome assessors will be blind of the assigned group single blinding
Reporting bias will be minimized by reporting all statistically and clinically significant and non-significant results in publications
Procedures for monitoring subject compliance Compliance will be monitored in real-time after each block of tasks Data are sent to dedicated and secured laboratory computer via Wi-Fi in a csv file containing the date time duration and performance of the 3D-MOT IVR stimulation performed If no files received for 72 hours the research team will contact the participants by phone andor email to inquire about the absence of data received Action will be taken accordingly Experience has shown that the main reason for the absence of data for 72 hours is a lost Wi-Fi connection As soon as Wi-Fi connection is restored all non-sent data will be sent automatically with timestamp
Safety parameters
AEs will be the safety endpoints Known AEs induced by IVR stimulation are nausea dizziness and disorientation The severity of these AEs will be scored using the validated VRISE questionnaire40 Three 3 consecutive VRISE scores 25 is considered as an AE
VRISE questionnaire will be recorded electronically csv file after each home-based session every 2 days and sent via Wi-Fi to a dedicated and secured laboratory computer in real-time
AE reporting will begin at the time of signing of the informed consent screening and will continue until discharge from the study AEs will be elicited by
spontaneous report by participants partnercaregiver andor healthcare staff
by 3 consecutive VRISE scores 25
by observation by the investigators andor healthcare staff AEs due to IVR stimulation resolve as soon as the stimulation stops Investigators will follow-up the participant at 24 hours by phone or email assessing the severity of the AEs using the VRISE questionnaire
Statistical methods
Analysis will be performed following an Intention-To-Treat ITT approach Results will be reported using descriptive statistics including frequency distributions a measure of central tendency and a measure of dispersion of the primary outcome average VRISE scores and secondary outcomes Data will be analyzed using the statistical software JASP Statistical comparison between the 2 groups and strata for the primary outcome will be made using Bayesian and frequentist two-way ANOVA with repeated measures
The investigators have developed an audiovisual stimulation procedure using immersive virtual reality IVR in head-mounted display HMD as a delivery platform IVR is an emerging and very promising approach for visual and auditory rehabilitation There are currently limited practical results whether this technology is suitable for low-vision patients to use at home and if it can be deployed on a large scale A few case reportseries studies suggested a potential effectiveness of IVR on visual perception in teenagers and young adults but more information as to the potential of use and effectiveness of this technology is necessary
Real-time measurement of task performance and neurophysiological signals while immersed in virtual reality can bring many benefits from monitoring experience-related factors to the development of bioneuromarkers In Multiple Object Tracking in 3D 3D-MOT visual tracking and detection is directly influenced by the speed of the spheres and is tailored to the participants performance using an adapted design to efficiently reach perceptual threshold therefore constantly challenging the patients perceptual abilities Progress made by the participants can be evaluated following real-time measures such as speed of the spheres percentage of positive hits and reaction time These outcomes naturally increase over sessions as a learning effect generally around 5-6 sessions in our settings but then quickly stabilize Further progress of performance is related to improvement in vision as a strong correlation between performance at 3D-MOT and functional vision outcomes is observed in our pilot studies
Eye-tracking measures eye position and movement using pupil position to infer fixation gaze durations saccadic velocities and saccadic amplitudes which altogether reveal strategies that lead to successful detection and tracking Eye-tracking has been extensively used during the 3D-MOT task to describe the strategies of attention allocation during visual tracking Targetheadeye-tracking measures positions recorded every 14 ms - 90Hz will be used to investigate the visual strategies head movement saccades fixation smooth pursuit developed by the participants to track the targets in 3D-MOT
Visual field recovery and restoration from hemianopsia has been postulated to occur from both improved function of perilesional tissue and recruitment of additional cortical structures to assume the function of the permanently damaged centers However longitudinal studies detailing functional and structural changes in the visual system before and after treatment are lacking EEG recordings in individuals with hemianopsia revealed some residual activity in V1 Here brain activity in V1 will be measured before and after treatment and in comparison between control and treated group using visually evoked potential VEP Retinal anatomy changes will be investigated between control and treated group by measuring the ganglion cell complex GCC integrity and the retinal nerve fiber layer RNFL thickness indicative of retinal ganglion cell atrophy using spectral domain optic coherence tomography SD-OCT a non-invasive imaging technique Brain scans Diffusion MRI Retinotopy will be performed using a 3T MRI at the Toronto site Advanced MRI Toronto Western Hospital University Health Network to visualize the integrity optic radiation and activity primary visual cortex of the visual system between control and treated group
Hypothesis Home-based audiovisual 3D-MOT IVR stimulation program will improve visual perception primary outcome Esterman binocular field test 3 points perceived in the blind field of individuals with hemianopsia and increase contrast sensitivity fixation stability reading speed and quality of life secondary outcomes
Following the ORBIT model a phase IIab single blind to assessor prospective randomized controlled multi-centre cross-over study involving 5 academic centres in Canada St Justine - Montreal CHUL - Quebec Alberta Childrens Hospital - Calgary BC Childrens Hospital - Vancouver and Hospital for Sick Children - Toronto will be performed Participants will be randomized into 2 groups Group 1 receives no treatment for the first 8 weeks and then start the 3D-MOT IVR program Group 2 starts with 3D-MOT IVR and then switches to an observation period for 8 weeks Using this cross-over design outcome measures at week 8 W8 - Period 1 will assess the effectiveness of 3D-MOT stimulation between the control non-treated G 1 and treated G 2 groups independent measures Primary outcomes assessment at week 16 W16 - Period 2 will measure the effectiveness of 3D-MOT IVR within Group 1 internal control repeated measures and the sustainability of the treatment in Group 2 repeated measures Visual assessments will be performed at baseline 8 and 16 weeks with follow-ups at 20 and 40 weeks W21 W42
Population
Male and female individuals aged 10 - 40 years old diagnosed with hemianopsia consecutive to a brain tumour with no prior visual rehabilitation interventions
Intervention
3D-MOT in immersive virtual reality
1 session every 2 days 1 day for 8 weeks 28 sessions total
1 session 3 blocks of 15 audiovisual stimulation tasks 2 min break between each block
1 task 20 seconds audiovisual IVR stimulation 3D-MOT correlated sound Rest time is 30 sec to 2 min between blocks 1 session lasts 19 min The duration of subjects participation is 8 months including follow-up Treatment period 8 weeks Follow-up period 6 months The expected frequency and duration of study visits anticipated time commitment for study participants Screeninginclusion visit 2-3 hours visit 1 Period change visit 15 hours visit 2 Final visit 2 hours visit 3 Follow-up visit 1 month 15 hours visit 4 Follow-up visit 6 months 15 hours visit 5
Primary outcome the Esterman binocular field testing will be performed at the ophthalmology clinic of the participating centers at baseline week 8 week 16 and follow-up at week 21 and week 42
There are no risks for participants enrolled in the study The use of IVR may cause moderate dizziness nausea or disorientation for continuous stimulation above 10 minutes If nausea dizziness or disorientation is experienced during IVR stimulation stopping the VR stimulation immediately restores normal condition
Participants will be assessed for IVR sensitivity using the Virtual reality Induced Symptoms and Effects VRISE questionnaire score at inclusion exclusion criteria three 3 consecutive VRISE score 25 At-home continuous VR stimulation will be 5 minutes of continuous stimulation below the critical 10 minutes threshold inducing effects and symptoms
Bias minimization
Selection bias will be addressed by randomly assigning participants to treatment or reference group using a permuted block randomization approach block size 2
Attrition bias will be addressed by including all participants who were randomized into the study intention-to-treat analysis
Performance and detection biases will be partially controlled for as primary outcome assessors will be blind of the assigned group single blinding
Reporting bias will be minimized by reporting all statistically and clinically significant and non-significant results in publications
Procedures for monitoring subject compliance Compliance will be monitored in real-time after each block of tasks Data are sent to dedicated and secured laboratory computer via Wi-Fi in a csv file containing the date time duration and performance of the 3D-MOT IVR stimulation performed If no files received for 72 hours the research team will contact the participants by phone andor email to inquire about the absence of data received Action will be taken accordingly Experience has shown that the main reason for the absence of data for 72 hours is a lost Wi-Fi connection As soon as Wi-Fi connection is restored all non-sent data will be sent automatically with timestamp
Safety parameters
AEs will be the safety endpoints Known AEs induced by IVR stimulation are nausea dizziness and disorientation The severity of these AEs will be scored using the validated VRISE questionnaire40 Three 3 consecutive VRISE scores 25 is considered as an AE
VRISE questionnaire will be recorded electronically csv file after each home-based session every 2 days and sent via Wi-Fi to a dedicated and secured laboratory computer in real-time
AE reporting will begin at the time of signing of the informed consent screening and will continue until discharge from the study AEs will be elicited by
spontaneous report by participants partnercaregiver andor healthcare staff
by 3 consecutive VRISE scores 25
by observation by the investigators andor healthcare staff AEs due to IVR stimulation resolve as soon as the stimulation stops Investigators will follow-up the participant at 24 hours by phone or email assessing the severity of the AEs using the VRISE questionnaire
Statistical methods
Analysis will be performed following an Intention-To-Treat ITT approach Results will be reported using descriptive statistics including frequency distributions a measure of central tendency and a measure of dispersion of the primary outcome average VRISE scores and secondary outcomes Data will be analyzed using the statistical software JASP Statistical comparison between the 2 groups and strata for the primary outcome will be made using Bayesian and frequentist two-way ANOVA with repeated measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None