Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients with Vestibular Schwannomas

Not Applicable

Recruiting

Interventions: Procedure: Microsurgical resection of VS
Radiation: Stereotactic radiosurgery
Other: PREHAB

Brief Summary: 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.

Detailed Description: Study Design: This is a pilot randomized study with enrollment of 9 patients each to 4 groups: PREHAB+Surgery, No PREHAB+Surgery, PREHAB+Radiosurgery, and No PREHAB+Radiosurgery. Eighteen patients will be enrolled to receive each treatment type: surgery and radiosurgery. Within each type, patients will be randomized to PREHAB or NO PREHAB at a 1:1 ratio using stratified permuted blocks. The treatment modality will be determined by the patient and investigator(s) based upon collective consultations with neuro-otology, neurosurgery, and radiation oncology aligned with the Medical College of Wisconsin sporadic VS treatment guidelines.

Study Intervention: A PREHAB visit will be done once weekly for three 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). Standard surgical approaches including retrosigmoid, translabyrinthine, and middle fossa and radiosurgical (SRS) delivery will be determined based on current VS management guidelines and followed by study randomization to PREHAB.

Recruitment & Eligibility

Inclusion Criteria

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
Eastern Cooperative Oncology Group (ECOG) Performance Status <2
Within 14 days of study registration, participants must have normal laboratory values that support safe treatment, at the discretion of the treating investigator
Be willing to adhere to outlined study protocol criteria and complete self-reported questionnaires (translations may be made available if the patient' primary language is not English).
For females of reproductive potential: must have a negative urine or serum pregnancy test 7 prior to enrollment and agreement to use of highly effective contraception method during study participation and for an additional 24 weeks after the completion of stereotactic radiosurgery.

Exclusion Criteria

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.)
Anticipated radiation other than stereotactic (fractionated)
Inability to undergo MRI scans safely
Allergy to Gadolinium contrast used for MRI scans
Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of study related treatment and additional 24 weeks following stereotactic radiosurgery administration.

Arm && Interventions

Group	Intervention	Description
Intervention: PREHAB and Surgery	PREHAB	PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo microsurgical resection of VS.
Control: Surgery (No PREHAB)	Microsurgical resection of VS	Subjects will undergo microsurgical resection of VS.
Intervention: PREHAB and Surgery	Microsurgical resection of VS	PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo microsurgical resection of VS.
Control: SRS (No PREHAB)	Stereotactic radiosurgery	Subjects will undergo stereotactic radiosurgery.
Intervention: PREHAB and SRS	Stereotactic radiosurgery	PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo stereotactic radiosurgery.
Intervention: PREHAB and SRS	PREHAB	PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo stereotactic radiosurgery.

Primary Outcome Measures

Name	Time	Method
Sensory Organization Test Score at Post-Treatment Assessments	Post-treatment 12 months	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.

Secondary Outcome Measures

Name	Time	Method

Locations (1): Froedtert Hospital and the Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States