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ClinicalTrials.gov ID

NCT07558395

Lead Sponsor

Institut National de la Santé Et de la Recherche Médicale, FranceOTHER_GOV

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

120Estimated

Last Update Posted

Apr 30, 2026Actual

Start Date

May 15, 2026Estimated

Primary Completion Date

Sep 2029Estimated

Completion Date

Sep 2029Estimated

Official Title

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

Brief Summary

Evaluate the efficiency of audiovisual stimulation in virtual reality for improving the visual perception of children, adolescents, and young adults with hemianopia resulting from pediatric brain tumors. These individuals can lose up to 50% of their visual field, significantly impacting their independence, mobility, and daily lives.

• Hemianopsia
• Virtual Reality
• Visual Rehabilitation
• Pediatric Brain Tumor

• Visual Stimulation
• standard of care

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Male and Female
• 10 - 40 years old
• Diagnosed hemianopsia (>12 months)
• History of diagnosis brain tumour
• Being stable for the tumour for > 6 months (either on therapy or not)
• Visual acuity ≤ 0.7 LogMAR
• Ability to follow the visual and auditory stimuli and training instructions
• Home WiFi access
• Ability to attend all on site visits
• Affiliation to the Social Security or beneficiary of such social protection

Exclusion Criteria:

• Age< 10 years old of > 40 years old
• Ocular disease
• Inability to perform during testing or training
• 3 consecutive VRISE scores < 25 at inclusion
• History of vertigo
• Prior vision rehabilitation interventions
• Recreational or medicinal consumption of psychoactive drugs
• Persons under court protection
• Interpupillary distance < 54mm

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Institut National de la Santé Et de la Recherche Médicale, FranceOTHER_GOV

Collaborators

Fight Kids CancerOTHER

Natacha.Entz-Werle@chru-strasbourg.fr0388128396

enrico.opocher@aopd.veneto.it390498211493

miriam.pavon@sjd.es34610570117