Clinical trial NCT05702749: Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients with Vestibular Schwannomas
Official title: Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients with Vestibular Schwannomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vestibular Schwannoma
Keywords: stereotactic radiosurgery
Vestibular Schwannoma
sensory organization test
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Study Design: This is a pilot randomized study with enrollment of 9 patients each to 4 groups: PREHAB+Surgery, No PREHAB+Surgery, PREHAB+Radiosurgery, and No PREHAB+Radiosurgery. Eighteen patients will be enrolled to receive each treatment type: surgery and radiosurgery. Within each type, patients will be randomized to PREHAB or NO PREHAB at a 1:1 ratio using stratified permuted blocks. The treatment modality will be determined by the patient and investigator(s) based upon collective consultations with neuro-otology, neurosurgery, and radiation oncology aligned with the Medical College of Wisconsin sporadic VS treatment guidelines.

Study Intervention: A PREHAB visit will be done once weekly for three 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). Standard surgical approaches including retrosigmoid, translabyrinthine, and middle fossa and radiosurgical (SRS) delivery will be determined based on current VS management guidelines and followed by study randomization to PREHAB.

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.

Primary outcomes:
measure: Sensory Organization Test Score at Post-Treatment Assessments
timeFrame: Post-treatment 1 week
measure: Sensory Organization Test Score at Post-Treatment Assessments
timeFrame: Post-treatment 6 weeks
measure: Sensory Organization Test Score at Post-Treatment Assessments
timeFrame: Post-treatment six months
measure: Sensory Organization Test Score at Post-Treatment Assessments
timeFrame: Post-treatment 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Michael Harris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whitney SL, Marchetti GF, Schade AI. The relationship between falls history and computerized dynamic posturography in persons with balance and vestibular disorders. Arch Phys Med Rehabil. 2006 Mar;87(3):402-7. doi: 10.1016/j.apmr.2005.11.002.
citation: Wrisley DM, Stephens MJ, Mosley S, Wojnowski A, Duffy J, Burkard R. Learning effects of repetitive administrations of the sensory organization test in healthy young adults. Arch Phys Med Rehabil. 2007 Aug;88(8):1049-54. doi: 10.1016/j.apmr.2007.05.003.
citation: Hall CD, Herdman SJ, Whitney SL, Anson ER, Carender WJ, Hoppes CW, Cass SP, Christy JB, Cohen HS, Fife TD, Furman JM, Shepard NT, Clendaniel RA, Dishman JD, Goebel JA, Meldrum D, Ryan C, Wallace RL, Woodward NJ. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Updated Clinical Practice Guideline From the Academy of Neurologic Physical Therapy of the American Physical Therapy Association. J Neurol Phys Ther. 2022 Apr 1;46(2):118-177. doi: 10.1097/NPT.0000000000000382.