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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-treatment 12 months
Awards & highlights
VS PREHAB Trial 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.Check my eligibility
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.See study design
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.
VS PREHAB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My doctor confirmed I have a Vestibular Schwannoma with an MRI.
Select...
I can do all or most of my daily activities without help.
Select...
My tumor is 2.5 cm or smaller and will be treated with surgery or stereotactic radiosurgery.
VS PREHAB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-treatment 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-treatment 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sensory Organization Test Score at Post-Treatment Assessments
VS PREHAB 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.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,677 Total Patients Enrolled
Michael Harris, MDPrincipal InvestigatorMedical College of Wisconsin
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatment for my VS, including surgery or radiotherapy.I am 18 years old or older.My doctor confirmed I have a Vestibular Schwannoma with an MRI.I am expected to receive radiation therapy that is not stereotactic.You are allergic to the contrast dye used for MRI scans.I do not have health issues like stroke or severe vision problems that affect my balance.I can do all or most of my daily activities without help.I have a diagnosed balance disorder like Meniere's or BPPV.My tumor is 2.5 cm or smaller and will be treated with surgery or stereotactic radiosurgery.You cannot safely have an MRI scan.I am under 18 years old.
Awards:
This trial has 0 awards, including:Research Study Groups:
This trial has the following groups:- Group 1: Intervention: PREHAB and Surgery
- Group 2: Control: Surgery (No PREHAB)
- Group 3: Intervention: PREHAB and SRS
- Group 4: Control: SRS (No PREHAB)
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings available to participate in this experiment?
"Clinicaltrials.gov reports that this medical trial, which was initial posted on March 1st 2023, is no longer looking for participants. However, 27 other studies are actively recruiting at the moment."
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