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

Launched by MEDICAL COLLEGE OF WISCONSIN · Jan 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how pre-treatment physical therapy can help patients with Vestibular Schwannomas (VS), which are tumors that can affect balance and hearing. The researchers want to see if those who participate in a specific rehab program before their treatment—whether that be surgery or a type of focused radiation called stereotactic radiosurgery—will have better balance outcomes compared to those who do not participate in the rehab program.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of a VS that is 2.5 cm or smaller. They should also be in good overall health and able to complete questionnaires about their health and balance. If you join the study, you will undergo balance assessments before and after your treatment to see how well the pre-treatment rehab worked. It's also important to know that if you are a woman capable of becoming pregnant, you will need to have a negative pregnancy test and use effective birth control during the study. The trial is currently looking for participants, and your involvement could contribute to understanding how to improve care for others with this condition.

Gender

ALL

Eligibility criteria

• 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 an internal auditory canal (IAC) MRI, in accordance with standard or institutional practice
• • 4. VS patients who present with a tumor size ≤2.5 cm and will be treated with surgery or SRS
• • 5. Eastern Cooperative Oncology Group (ECOG) Performance Status \<2
• • 6. Within 14 days of study registration, participants must have normal laboratory values that support safe treatment, at the discretion of the treating investigator
• • 7. 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).
• • 8. 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:
• • 1. Subjects less than 18 years of age
• • 2. Prior treatment of VS including radiotherapy or surgery or treatment for disease recurrence or planned salvage procedure
• • 3. Pre-existing, secondary vestibular diagnoses (e.g., Meniere's, intractable benign paroxysmal positional vertigo (BPPV), vestibular migraine, 3PD).
• • 4. Other medical comorbidities know to significantly impair/affect balance and/or vestibular function testing (e.g., prior stroke, uncorrected visual impairment or blindness, 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 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.