Recruiting

Vestibular Rehabilitation

Sponsor:

Medical College of Wisconsin

Code:

NCT05702749

Conditions

Vestibular Schwannoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Microsurgical resection of VS

Stereotactic radiosurgery

PREHAB

Study Details

Brief 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.

Conditions

Vestibular Schwannoma

Study ID

NCT05702749

Start date

Jan 22, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Intervention: PREHAB and Surgery

PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo microsurgical resection of VS.

placebo comparator: Control: Surgery (No PREHAB)

Subjects will undergo microsurgical resection of VS.

active comparator: Intervention: PREHAB and SRS

PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo stereotactic radiosurgery.

placebo comparator: Control: SRS (No PREHAB)

Subjects will undergo stereotactic radiosurgery.

Interventions

Microsurgical resection of VS

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.

Stereotactic radiosurgery

Radiation therapy will be delivered using single fraction stereotactic radiosurgery with Gamma knife technology, or linear accelerator following institutional standard of care.

PREHAB

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).

Primary outcome measure

  • Sensory Organization Test Score at Post-Treatment Assessments [ Time Frame: Post-treatment 1 week ]
  • Sensory Organization Test Score at Post-Treatment Assessments [ Time Frame: Post-treatment 6 weeks ]
  • Sensory Organization Test Score at Post-Treatment Assessments [ Time Frame: Post-treatment six months ]
  • Sensory Organization Test Score at Post-Treatment Assessments [ Time Frame: Post-treatment 12 months ]

Central Contacts and Locations

Central contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

866-680-0505cccto@mcw.edu

Locations

Froedtert Hospital and the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Michael Harris, MD

msharris@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

  • stereotactic radiosurgery
  • Vestibular Schwannoma
  • sensory organization test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-03-24.