Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas (NCT05702749) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas
United States36 participantsStarted 2024-01-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of signed and dated informed consent form
. Male or female participants ≥18 years of age.
. Initial diagnosis of a Vestibular Schwannoma confirmed by a physician with an internal auditory canal (IAC) MRI, in accordance with standard or institutional practice
. VS patients who present with a tumor size ≤2.5 cm and will be treated with surgery or SRS
. Eastern Cooperative Oncology Group (ECOG) Performance Status \<2
. Within 14 days of study registration, participants must have normal laboratory values that support safe treatment, at the discretion of the treating investigator
. 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).
. 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
. Subjects less than 18 years of age
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensory Organization Test Score at Post-Treatment Assessments
Timeframe: Post-treatment 1 week
2
Sensory Organization Test Score at Post-Treatment Assessments
Timeframe: Post-treatment 6 weeks
3
Sensory Organization Test Score at Post-Treatment Assessments
Timeframe: Post-treatment six months
4
Sensory Organization Test Score at Post-Treatment Assessments
Timeframe: Post-treatment 12 months
Trial details
NCT IDNCT05702749
SponsorMedical College of Wisconsin
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-07
Contact for this trial
Medical College of Wisconsin Cancer Center Clinical Trials Office
. Other medical comorbidities know to significantly impair/affect balance and/or vestibular function testing (e.g., prior stroke, uncorrected visual impairment or blindness, etc.)
. Anticipated radiation other than stereotactic (fractionated)
. Inability to undergo MRI scans safely
. Allergy to Gadolinium contrast used for MRI scans
. 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.