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

Trial Title: Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas

NCT ID: NCT05702749

Condition: Vestibular Schwannoma

Conditions: Official terms:
Neurilemmoma
Neuroma, Acoustic

Conditions: Keywords:
stereotactic radiosurgery
Vestibular Schwannoma
sensory organization test

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Microsurgical resection of VS
Description: 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.
Arm group label: Control: Surgery (No PREHAB)
Arm group label: Intervention: PREHAB and Surgery

Intervention type: Radiation
Intervention name: Stereotactic radiosurgery
Description: Radiation therapy will be delivered using single fraction stereotactic radiosurgery with Gamma knife technology, or linear accelerator following institutional standard of care.
Arm group label: Control: SRS (No PREHAB)
Arm group label: Intervention: PREHAB and SRS

Intervention type: Other
Intervention name: PREHAB
Description: 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).
Arm group label: Intervention: PREHAB and SRS
Arm group label: Intervention: PREHAB and Surgery

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Froedtert Hospital and the Medical College of Wisconsin

Address:
City: Milwaukee
Zip: 53226
Country: United States

Status: Recruiting

Contact:
Last name: Michael Harris, MD
Email: msharris@mcw.edu

Start date: January 22, 2024

Completion date: December 2027

Lead sponsor:
Agency: Medical College of Wisconsin
Agency class: Other

Source: Medical College of Wisconsin

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05702749