Phase
Condition
Hearing Loss
Neurofibromatosis
Vestibular Hypofunction
Treatment
Microsurgical resection of VS
Stereotactic radiosurgery
PREHAB
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 aninternal auditory canal (IAC) MRI, in accordance with standard or institutionalpractice
VS patients who present with a tumor size ≤2.5 cm and will be treated with surgeryor SRS
Eastern Cooperative Oncology Group (ECOG) Performance Status <2
Within 14 days of study registration, participants must have normal laboratoryvalues that support safe treatment, at the discretion of the treating investigator
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).
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:
Subjects less than 18 years of age
Prior treatment of VS including radiotherapy or surgery or treatment for diseaserecurrence or planned salvage procedure
Pre-existing, secondary vestibular diagnoses (e.g., Meniere's, intractable benignparoxysmal positional vertigo (BPPV), vestibular migraine, 3PD).
Other medical comorbidities know to significantly impair/affect balance and/orvestibular function testing (e.g., prior stroke, uncorrected visual impairment orblindness, 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 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
Study Description
Connect with a study center
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting

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