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New treatment option for Vestibular Schwannoma
Official title Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas
ClinicalTrials.gov ID: NCT05702749
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- people less than 18 years of age
- Prior treatment of VS including radiotherapy or surgery or treatment for disease recurrence or planned salvage procedure
- Pre-existing, secondary vestibular diagnoses (e.g., Meniere's, intractable benign paroxysmal positional vertigo (BPPV), vestibular migraine, 3PD).
- Other medical comorbidities know to significantly impair/affect balance and/or vestibular function testing (e.g., prior stroke, uncorrected visual...
- Anticipated radiation other than stereotactic (fractionated)
- Inability to undergo MRI scans safely
See the full eligibility 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...
- people less than 18 years of age
- Prior treatment of VS including radiotherapy or surgery or treatment for disease recurrence or planned salvage procedure
- Pre-existing, secondary vestibular diagnoses (e.g., Meniere's, intractable benign paroxysmal positional vertigo (BPPV), vestibular migraine, 3PD).
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.