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

Last updated: March 20, 2026
Sponsor: Medical College of Wisconsin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Loss

Neurofibromatosis

Vestibular Hypofunction

Treatment

Microsurgical resection of VS

Stereotactic radiosurgery

PREHAB

Clinical Study ID

NCT05702749
PRO00046306
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated informed consent form

  2. Male or female participants ≥18 years of age.

  3. Initial diagnosis of a Vestibular Schwannoma confirmed by a physician with aninternal auditory canal (IAC) MRI, in accordance with standard or institutionalpractice

  4. VS patients who present with a tumor size ≤2.5 cm and will be treated with surgeryor SRS

  5. Eastern Cooperative Oncology Group (ECOG) Performance Status <2

  6. Within 14 days of study registration, participants must have normal laboratoryvalues that support safe treatment, at the discretion of the treating investigator

  7. Be willing to adhere to outlined study protocol criteria and complete self-reportedquestionnaires (translations may be made available if the patient' primary languageis not English).

  8. For females of reproductive potential: must have a negative urine or serum pregnancytest 7 prior to enrollment and agreement to use of highly effective contraceptionmethod during study participation and for an additional 24 weeks after thecompletion of stereotactic radiosurgery.

Exclusion

Exclusion Criteria:

  1. Subjects less than 18 years of age

  2. Prior treatment of VS including radiotherapy or surgery or treatment for diseaserecurrence or planned salvage procedure

  3. Pre-existing, secondary vestibular diagnoses (e.g., Meniere's, intractable benignparoxysmal positional vertigo (BPPV), vestibular migraine, 3PD).

  4. Other medical comorbidities know to significantly impair/affect balance and/orvestibular function testing (e.g., prior stroke, uncorrected visual impairment orblindness, etc.)

  5. Anticipated radiation other than stereotactic (fractionated)

  6. Inability to undergo MRI scans safely

  7. Allergy to Gadolinium contrast used for MRI scans

  8. Women of childbearing potential who are known to be pregnant or are unwilling to usean acceptable method of contraception from the time of informed consent untilcompletion of study related treatment and additional 24 weeks following stereotacticradiosurgery administration.

Study Design

Total Participants: 36
Treatment Group(s): 3
Primary Treatment: Microsurgical resection of VS
Phase:
Study Start date:
January 22, 2024
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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