Neoplasms

Nervous System Diseases

All Conditions

Eye Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Rare Diseases

Brain Neoplasms

Hemianopsia

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Vision Disorders

Sensation Disorders

Neurologic Manifestations

Blindness

Quality of Life

Brain Tumor, Childhood

8-week audiovisual stimulation followed by 8-week no intervention

8-week no intervention followed by 8-week audiovisual stimulation

The MOT IVR audiovisual stimulation task involves the 3D multiple-object-tracking paradigm composed of 6-8 high-contrast spheres which features are adapted to the visual ability of individuals with low-vision (luminosity = 80 nits, size = 1° to 3° visual angle). The spheres move for 20s. following random linear paths, bouncing on one another and on the walls of a virtual 3D cube when collisions occur. The participant, comfortably seated, is asked to track the moving cued target among moving distractors for 20s. A spatial sound is correlated to the movement of the cued target. After 20s., the movement stops and the participant is asked to select, using a laser pointer, the cued sphere among the distractors (mark-all procedure). Speed of the spheres is regulated by a staircase 1:1 procedure. The stimulation can here be stopped by the participant if required. After 3 blocks of 15x20s., the system stops and goes on stand-by mode until the next session. Data are collected in real time.

Audiovisual stimulation

Michael Reber, PhD

Eric Bouffet, MD

Lucie Lafay-Cousin, MD

Sylvia Cheng, MD

Uri Tabori, MD

Inci Yaman Bajin, MD

Sebastien Perreault, MD

Valerie Larouche, MD

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 Re:Vision program on visual fields, visual perception and quality of life.

Our objective is to evaluate the effectiveness of Re:Vision, 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 IIa/b 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.

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 optimize/improve 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 report/series 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 bio/neuromarkers. 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 patient's 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. Target/head/eye-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 IIa/b, single blind (to assessor), prospective, randomized, controlled, multi-centre, cross-over study involving 5 academic centres in Canada (St Justine - Montreal, CHUL - Quebec, Alberta Children's Hospital - Calgary, BC Children's 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 subject's 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 Screening/inclusion visit: 2-3 hours (visit 1) Period change visit: 1.5 hours (visit 2) Final visit: 2 hours (visit 3) Follow-up visit 1 month: 1.5 hours (visit 4) Follow-up visit 6 months: 1.5 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 and/or 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, partner/caregiver and/or healthcare staff,
* by 3 consecutive VRISE scores \< 25,
* by observation (by the investigators and/or 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.

Visual Telerehabilitation in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour

Effectiveness of a Visual Telerehabilitation Program on Visual Perception in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour.

It is not yet known if there will be a plan to make IPD available. Will decide after consulting with all site lead investigators.

Difference in brain activity (VEP EEG) between intervention and non-intervention groups and pre/post-intervention. Measures of N75, P100 and N175 latency (ms) and amplitude (microV) during monocular pattern reversal stimulation.

Difference in retinal fiber layer thickness (RNFL) between intervention and non-intervention groups and pre/post-intervention

Measures of optic tract density will be performed by diffusion tensor MRI (DTI - fractional anisotropy, tractography) between intervention and non-intervention groups and pre/post-intervention

Retinotopic visual stimulation will be performed by visual stimulation at 4 different retinal positions and measured using population receptive field (voxels value) between intervention and non-intervention groups and pre/post-intervention

Head position during the 3D-MOT will be measured as a function of time along the horizontal and vertical axes in degree and compared between each session.

Eyes positions during the 3D-MOT will be measured as a function of time along the horizontal and vertical axes in degree and compared between each session.

Difference in the number of points perceived in the Esterman binocular field test between intervention and non-intervention groups and pre/post-intervention

Difference in quality of vision questionnaire scores between intervention and non-intervention groups and pre/post-intervention. Scores are from 0 to 100. High scores represents better outcome.

Difference in the number of words per minute (at critical print size) between intervention and non-intervention groups and pre/post-intervention

Difference in fixation stability (BCEA 63%, degree square) between intervention and non-intervention groups and pre/post-intervention

Difference in contrast sensitivity (logit) bewteen intervention and non-intervention groups and pre/post-intervention

Alberta Children's Hospital

St. Justine's Hospital

The Hospital for Sick Children

British Columbia Children's Hospital

University Health Network, Toronto

Principal Investigator

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

One experimental group of NF1 children with 3 reading levels (1st grade, 2nd grade and 3rd grade). For this research they will pass :

* Neuropsychological evaluation
* Evaluation of the reading assistance technique

Neuropsychological evaluation (about 60 min) the same day realized by a student in Science Thesis under the responsibility of Prof. Yves Chaix and including:

* Process evaluation:
* Oculomotors: DEM test (5min)
* Visuo-attention: computerized STROOP (15min)
* Visuo-Perceptive: DTVP3 (30min)
* Phonological \& lexical: Exalang (10min)

Neuropsychological evaluation

Evaluation of the reading assistance technique (about 30 min) and comprising:

- Reading evaluation:Test lark (3min) Experimental task: 3-way help with reading (without help, color help and highlight help (25 min)

Evaluation of the reading assistance technique

Yves Chaix, MD

Isabelle Olivier, PhD

Isabelle Olivier, MD

The present project will therefore focus upon those processes related to visual attention and perceptual abilities and on their potential to explain reading behavior and reading problems in NF1. The main objective of this study is to clarify the specificity and heterogeneity of reading profiles and the causes of its disturbance in NF1. In particular, this project allow the investigators to study more precisely the relations between perceptual, oculomotor and visuo-attentional skills in NF1 children and reading abilities. In addition, a new oculomotor/perceptual reading aid for NF1 children will be evaluated. The investigators believe that the early intervention for perceptual, visuo-attentional or oculomotor problems may promote academic skill development.

Although some NF1 children manage in the end to exhibit "expert" reading behavior, a non-negligible number of them have real problems learning this skill. Today's estimates indicate that 30-60% of NF1 children suffer from written-language learning disorder. Studies of the effects of the neurocognitive deficit on academic performance are relatively rare, owing to the small size of the populations concerned. However, research is needed to develop effective rehabilitation programs. At the current time, most tools available to professionals are designed for the evaluation and remediation of child language problems, particularly difficulties related to the acquisition of meta-phonological skills. The findings from dyslexics and typically developing readers however suggest a strong relationship between reading ability and visual processing. The main goal of this study is to investigate the occurrence of perceptual, visuo-attentional and oculomotor deficits in NF1 children and their potential to explain reading behavior and reading problems in this population. The investigators hope to contribute to the process of clarifying the specificity and heterogeneity of reading profiles and the causes of its disturbance in NF1. The second objective of the study is to evaluate an oculomotor/perceptual reading aid for NF1 children; in particular, the idea of the training is to help the readers to land their saccades at the optimal viewing position1 (OVP) of each word (highlighting the letter at the OVP or putting it in color, so that the saccades they make would land near the centre of the word, at the OVP). Eye movement control during reading is a highly automated process; people are not aware of most of the saccades and fixations they make. This tool is a way to train children to control these subconscious saccades and fixations. Note that, our team has already demonstrated the usefulness of this reading aid for beginning readers. This project have important implications from a clinical perspective, by providing the opportunity to gain insight into the reading difficulties of NF1 children, in view of establishing thorough and accurate assessment procedures and proposing child-specific guidelines and remediation methods that take into account the particular processes affected. Providing a clearer picture of visuo-attentional and perceptual skills in children with NF1 would be of considerable clinical benefit, not least for supporting targeted clinical practices. Moreover, NF1 children could benefit from a new remediation tool that allow them to have feedback on their reading ability, and to read more easily, more rapidly, and with better comprehension. If appropriate interventions are implemented at an early age, academic skill development could be altered, preventing subtle learning difficulties from becoming more pronounced over time.

Vision, Attention and Reading in Neurofibromatosis Type 1 (NF1) Children

The visual process : Oculomotor Processes : Vertical,Horizontal Time with the Ratio with the Developmental Eye Movement Test (DEM test) : a standard of evaluation oculomotor in children with reading difficulties

The visual process : Visuo-perceptual process : it's a composite score : Composite score of perceptual treatment with pure visual perception score and visuo-motor integration with a Developmental Test of Visual Perception, 3rd (DTVP3) test is Visual perception development test

Visual-attentional process : reaction time (milli Sec) with the percentage of correct answers to the computerized Stroop to show that attention is a selective process and that it is very difficult to read and name colors at the same time

To evaluate language skills like phonological awareness with lexical stock Alouette Reading Test's aim is for the accuracy index and CTL speed index :The Alouette test is a reading test that evaluates the level of lexical decoding (automaticity). It consists of reading a standard text aloud and count the number of words read and errors in a given time

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Visual Telerehabilitation in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour	NCT06362434	Hemianopsia	Audiovisual sti...	10 Years - 40 Years	University Health Network, Toronto
Vision, Attention and Reading in Neurofibromatosis Type 1 (NF1) Children	NCT03518710	Neurofibromatos...	Neuropsychologi... Evaluation of t...	7 Years - 9 Years	University Hospital, Toulouse
Visual Telerehabilitation in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour	NCT06362434	Hemianopsia	Audiovisual sti...	10 Years - 40 Years	University Health Network, Toronto

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Spots Global Cancer Trial Database for reading

Every month we try and update this database with for reading cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for reading cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.