Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas
Medical College of Wisconsin
36 participants
Jan 22, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria8
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Microsurgical 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.
Radiation therapy will be delivered using single fraction stereotactic radiosurgery with Gamma knife technology, or linear accelerator following institutional standard of care.
A 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).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05702749