RECRUITING

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

Conditions

Vestibular Schwannoma stereotactic radiosurgery sensory organization test

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-22

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05702749

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505

cccto@mcw.edu

Principal Investigator

Michael Harris, MD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Michael Harris, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-22

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-01-22

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

stereotactic radiosurgery
Vestibular Schwannoma
sensory organization test

Additional Relevant MeSH Terms

Vestibular Schwannoma