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Pre-Treatment Physical Therapy for Acoustic Neuroma (VS PREHAB Trial)

N/A

Recruiting

Led By Michael Harris, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Initial diagnosis of a Vestibular Schwannoma confirmed by a physician with an internal auditory canal (IAC) MRI, in accordance with standard or institutional practice

Eastern Cooperative Oncology Group (ECOG) Performance Status <2

Must not have

Prior treatment of VS including radiotherapy or surgery or treatment for disease recurrence or planned salvage procedure

Anticipated radiation other than stereotactic (fractionated)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment 12 months

Summary

This trial will measure balance in patients with Vestibular Schwannomas before and after treatment with surgery or radiotherapy with or without physical therapy.

Who is the study for?

Adults diagnosed with Vestibular Schwannoma (VS) of size ≤2.5 cm, confirmed by MRI, who will undergo surgery or radiosurgery. Participants must be in good health as determined by normal lab values and have an ECOG Performance Status <2. Pregnant women or those not using effective contraception are excluded.

What is being tested?

The trial is testing the effectiveness of pre-treatment vestibular physical therapy (PREHAB) on balance for patients with VS undergoing microsurgical resection or stereotactic radiosurgery compared to no PREHAB.

What are the potential side effects?

Potential side effects may include discomfort from physical therapy exercises, typical surgical risks like infection or bleeding for those undergoing resection, and common radiosurgery side effects such as headaches, nausea, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My doctor confirmed I have a Vestibular Schwannoma with an MRI.

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I can do all or most of my daily activities without help.

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My tumor is 2.5 cm or smaller and will be treated with surgery or stereotactic radiosurgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatment for my VS, including surgery or radiotherapy.

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I am expected to receive radiation therapy that is not stereotactic.

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I do not have health issues like stroke or severe vision problems that affect my balance.

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I have a diagnosed balance disorder like Meniere's or BPPV.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-treatment 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sensory Organization Test Score at Post-Treatment Assessments

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Intervention: PREHAB and SurgeryActive Control2 Interventions

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.

Group II: Intervention: PREHAB and SRSActive Control2 Interventions

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.

Group III: Control: Surgery (No PREHAB)Placebo Group1 Intervention

Subjects will undergo microsurgical resection of VS.

Group IV: Control: SRS (No PREHAB)Placebo Group1 Intervention

Subjects will undergo stereotactic radiosurgery.

0 / 8Eligibility criteria met