The study is a pilot efficacy study. The investigators aim to estimate mean baseline and post-treatment balance scores among Vestibular Schwannomas (VS) patients undergoing pretreatment rehab (PREHAB) or no PREHAB when managed with either surgery or radiosurgery.
Provision of signed and dated informed consent form
Male or female participants ≥18 years of age.
Initial diagnosis of a Vestibular Schwannoma confirmed by a physician with an internal auditory canal (IAC) MRI, in accordance with standard or institutional practice
VS patients who present with a tumor size ≤2.5 cm and will be treated with surgery or SRS
Subjects less than 18 years of age
Prior treatment of VS including radiotherapy or surgery or treatment for disease recurrence or planned salvage procedure
Pre-existing, secondary vestibular diagnoses (e.g., Meniere's, intractable benign paroxysmal positional vertigo (BPPV), vestibular migraine, 3PD).
Other medical comorbidities know to significantly impair/affect balance and/or vestibular function testing (e.g., prior stroke, uncorrected visual impairment or blindness, etc.)
Parallel
Microsurgical resection of VS
Procedure/SurgeryMicrosurgical resection of VSs can be accomplished by three approaches including middle cranial fossa, retrosigmoid, and translabyrinthine. The surgical approach utilized is typically selected on the basis of tumor location and size, and patient age and hearing status.
Stereotactic radiosurgery
RadiationRadiation therapy will be delivered using single fraction stereotactic radiosurgery with Gamma knife technology, or linear accelerator following institutional standard of care.
PREHAB
Other interventionA PREHAB visit will be done once weekly for 3 weeks to determine exercise regimen prior to surgery or radiotherapy. Therapy includes balance exercises (twice daily), gaze stabilization exercises (12-20 minutes daily), and habituation exercises (as applicable).
Sensory Organization Test Score at Post-Treatment Assessments
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Sensory Organization Test Score at Post-Treatment Assessments
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Sensory Organization Test Score at Post-Treatment Assessments
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Sensory Organization Test Score at Post-Treatment Assessments
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Click on the lead sponsor to view all of their trials.
