Evaluating pre-treatment vestibular therapy for patients with vestibular schwannomas
Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas
This study is testing if doing balance therapy before surgery or radiation can help people with vestibular schwannomas recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05702749 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the efficacy of pre-treatment vestibular physical therapy (PREHAB) for patients diagnosed with vestibular schwannomas. Participants will be randomized into four groups based on whether they receive PREHAB before undergoing surgery or stereotactic radiosurgery. The study will measure balance scores before and after treatment to determine the impact of PREHAB on recovery outcomes. The intervention includes weekly therapy sessions focusing on balance, gaze stabilization, and habituation exercises tailored to individual needs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of vestibular schwannoma measuring 2.5 cm or less, who are scheduled for surgery or radiosurgery.
Not a fit: Patients with vestibular schwannomas larger than 2.5 cm or those with an ECOG performance status of 2 or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance balance recovery and overall quality of life for patients undergoing treatment for vestibular schwannomas.
How similar studies have performed: While this approach is relatively novel, similar studies in vestibular rehabilitation have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milwaukee, Wisconsin
- Froedtert Hospital and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Michael Harris, MD — Medical College of Wisconsin
- Study coordinator: Medical College of Wisconsin Cancer Center Clinical Trials Office
- Email: cccto@mcw.edu
- Phone: 866-680-0505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.