Back to resultsEvaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas (VS PREHAB)
Primary Purpose
Vestibular Schwannoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microsurgical resection of VS
Stereotactic radiosurgery
PREHAB
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Schwannoma focused on measuring stereotactic radiosurgery, Vestibular Schwannoma, sensory organization test
Eligibility Criteria
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 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 weeks following stereotactic radiosurgery administration.
Sites / Locations
- Froedtert Hospital and the Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
Intervention: PREHAB and Surgery
Control: Surgery (No PREHAB)
Intervention: PREHAB and SRS
Control: SRS (No PREHAB)
Arm Description
PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo microsurgical resection of VS.
Subjects will undergo microsurgical resection of VS.
PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo stereotactic radiosurgery.
Subjects will undergo stereotactic radiosurgery.
Outcomes
Primary Outcome Measures
Sensory Organization Test Score at Post-Treatment Assessments
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Sensory Organization Test Score at Post-Treatment Assessments
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Sensory Organization Test Score at Post-Treatment Assessments
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Sensory Organization Test Score at Post-Treatment Assessments
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Secondary Outcome Measures
Full Information
NCT ID
NCT05702749
First Posted
January 9, 2023
Last Updated
August 1, 2023
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT05702749
Brief Title
Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas
Acronym
VS PREHAB
Official Title
Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
July 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Schwannoma
Keywords
stereotactic radiosurgery, Vestibular Schwannoma, sensory organization test
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention: PREHAB and Surgery
Arm Type
Active Comparator
Arm Description
PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo microsurgical resection of VS.
Arm Title
Control: Surgery (No PREHAB)
Arm Type
Placebo Comparator
Arm Description
Subjects will undergo microsurgical resection of VS.
Arm Title
Intervention: PREHAB and SRS
Arm Type
Active Comparator
Arm Description
PREHAB exercises will be determined during the physical therapy visit (1x/week) and completed daily with varying frequency for three weeks. Subjects will undergo stereotactic radiosurgery.
Arm Title
Control: SRS (No PREHAB)
Arm Type
Placebo Comparator
Arm Description
Subjects will undergo stereotactic radiosurgery.
Intervention Type
Procedure
Intervention Name(s)
Microsurgical resection of VS
Intervention 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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiosurgery
Intervention Description
Radiation therapy will be delivered using single fraction stereotactic radiosurgery with Gamma knife technology, or linear accelerator following institutional standard of care.
Intervention Type
Other
Intervention Name(s)
PREHAB
Intervention 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).
Primary Outcome Measure Information:
Title
Sensory Organization Test Score at Post-Treatment Assessments
Description
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Time Frame
Post-treatment 1 week
Title
Sensory Organization Test Score at Post-Treatment Assessments
Description
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Time Frame
Post-treatment 6 weeks
Title
Sensory Organization Test Score at Post-Treatment Assessments
Description
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Time Frame
Post-treatment six months
Title
Sensory Organization Test Score at Post-Treatment Assessments
Description
The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. The primary endpoint is the SOT at post-treatment assessments. This is measured by a composite score. A higher score equals greater stability. The measurement is made by a Bertec machine.
Time Frame
Post-treatment 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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 weeks following stereotactic radiosurgery administration.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical College of Wisconsin Cancer Center Clinical Trials Office
Phone
866-680-0505
Ext
8900
Email
cccto@mcw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Harris, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert Hospital and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Harris, MD
Email
msharris@mcw.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16500176
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.
Results Reference
background
PubMed Identifier
17678669
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.
Results Reference
background
PubMed Identifier
34864777
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.
Results Reference
background
Learn more about this trial
Evaluating Pre-Treatment Vestibular Physical Therapy Rehab for Patients With Vestibular Schwannomas
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