Nimodipine in Vestibular Schwanommas
Primary Purpose
Vestibular Schwannoma
Status
Recruiting
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
NiMODipine Injectable Solution
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Vestibular Schwannoma
Eligibility Criteria
Inclusion Criteria:
- Age > 18a
- Vestibular schwannoma with maximum diameter of 10-25mm on MRI
- Pre-operative audiogram
- Informed consent
Exclusion Criteria:
- Contraindication for nimodipine application
- Vestibularis schwannoma diameter <10mm or >25mm on MRI
Sites / Locations
- Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nimodipine
Placebo
Arm Description
During surgery a nimodipine soaked gel foam pad is administered to the cranial nerves VII and VIII
During surgery a sodium chloride soaked gel foam pad is administered to the cranial nerves VII and VIII
Outcomes
Primary Outcome Measures
Facial nerve function
Function of the facial nerve according to House-Brackmann score. The House Brackmann score includes values from 1 to 6: 1 = normal function, 2 = minimal paresis, 3 = noticable paresis, 4 = severe paresis, 5 = minimum fuction, 6 = complete paralysis
Hearing
Serviceable or non-serviceable hearing according to Gardner-Robertson scale. The Gardner-Robertson scale indludes values from 1 to 5: 1 and 2 indicating serviceable hearing, 3-5 indicating non-serviceable hearing. The scores from 1 to 5 differ in values of pure tone audiometry and speech discrimination, 1 indicates best function and 5 worst function.
Secondary Outcome Measures
Full Information
NCT ID
NCT04801953
First Posted
March 13, 2021
Last Updated
October 18, 2023
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04801953
Brief Title
Nimodipine in Vestibular Schwanommas
Official Title
Intraoperative Application of Nimodipine to the Facial and Cochlear Nerves During Vestibular Schwannoma Resection to Avoid Spasm-related Postoperative Facial Paralysis and Deafness - a Prospective Randomized Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
April 9, 2024 (Anticipated)
Study Completion Date
April 9, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Title:
Intraoperative application of nimodipine to the facial and cochlear nerves during vestibular schwannoma resection to avoid spasm-related postoperative facial paralysis and deafness - a prospective randomized study
Background:
In patients undergoing microsurgical resection of a vestibular schwannoma, the facial and vestibulocochlear nerves are at risk. Prior studies suggested positive effects of nimodipine for preservation of the nerve function in these patients. A prospective, randomized, placebo controlled double-blinded study will be conducted to evaluate the neuro-protective effect of locally administered nimodipine during resection of vestibular schwannomas.
Investigational drug:
active group: "Nimotop® 10mg - Infusionsflasche" placebo: "Natrium chloratum physiologicum 0,9% - Medica Infusionslösung"
Rationale for the study: Nimodipine is supposed to counteract the vasoconstriction of cerebral arteries caused by microsurgical manipulation and might thereby preserve facial and cochlear nerve function
Aims of the study: Evaluation of the effect of intraoperative local administration of nimodipine on the postoperative function of the facial and vestibulocochlear nerves after microsurgical resection of vestibular schwannomas
Study design: prospective, double-blinded, single-center, randomized phase III trial
Study population: Patients undergoing microsurgical resection of a vestibularis schwannoma with a maximum diameter of 10-25mm on MRI at the Department of Neurosurgery, Medical university of Vienna.
Number of Patients: 30
Methods: In 15 patients, nimodipine will be administered locally to the facial and vestibulocochlear nerves during resection of a vestibular schwannoma (= treatment group). In another 15 patients, a placebo (sodium chloride solution) will be administered. In both cases, a soaked gel foam pad will be used. The operating team and the patient will both be blinded during the procedure. Facial nerve function and hearing will be assessed prior and three months after surgery.
Outcome variables: Serviceable or non-serviceable hearing according to Gardner-Robertson hearing scale and House-Brackmann score for the assessment of facial nerve function
Statistical analysis: For the evaluation of the postoperative function of the vestibulocochlear nerve, the number of patients with postoperative serviceable hearing (Gardner-Robertson I-II) and postoperative non-serviceable hearing (Gardner-Robertson III-V) will be compared between both groups. For the evaluation of the facial nerve function, the number of patients with favorable postoperative outcome (House-Brackmann I-III) and non-favorable postoperative outcome (House-Brackmann IV-VI) will be compared. In both cases, fisher's exact test will be used.
Expected risks/inconveniences: Administration of nimodipine is associated with the following adverse effects: thrombocytopenia, allergic reactions, headache, tachycardia, hypotension, nausea (occasionally) and bradycardia, ileus, reversibly elevated liver enzymes (seldom)
Risk/benefit assessment: Expected adverse effects of local nimodipine administration are manageable and patients may profit from the use of nimodipine. No severe adverse events are expected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Schwannoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nimodipine
Arm Type
Active Comparator
Arm Description
During surgery a nimodipine soaked gel foam pad is administered to the cranial nerves VII and VIII
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
During surgery a sodium chloride soaked gel foam pad is administered to the cranial nerves VII and VIII
Intervention Type
Drug
Intervention Name(s)
NiMODipine Injectable Solution
Intervention Description
nimodipine solution is applied to cranial nerves during resection of vestibular schwannoma
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Sodium chloride solution is applied to cranial nerves during surgery
Primary Outcome Measure Information:
Title
Facial nerve function
Description
Function of the facial nerve according to House-Brackmann score. The House Brackmann score includes values from 1 to 6: 1 = normal function, 2 = minimal paresis, 3 = noticable paresis, 4 = severe paresis, 5 = minimum fuction, 6 = complete paralysis
Time Frame
90 days after surgery
Title
Hearing
Description
Serviceable or non-serviceable hearing according to Gardner-Robertson scale. The Gardner-Robertson scale indludes values from 1 to 5: 1 and 2 indicating serviceable hearing, 3-5 indicating non-serviceable hearing. The scores from 1 to 5 differ in values of pure tone audiometry and speech discrimination, 1 indicates best function and 5 worst function.
Time Frame
90 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age > 18a
Vestibular schwannoma with maximum diameter of 10-25mm on MRI
Pre-operative audiogram
Informed consent
Exclusion Criteria:
Contraindication for nimodipine application
Vestibularis schwannoma diameter <10mm or >25mm on MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorian Hirschmann, Dr
Phone
+434040025780
Email
dorian.hirschmann@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorian Hirschmann, MD
Organizational Affiliation
University Clinic of Neurosurgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karl Roessler, MD
Organizational Affiliation
University Clinic of Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorian Hirschmann, MD
Phone
+4314040025780
Email
dorian.hirschmann@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Arthur Hosmann, MD
Phone
+4314040025780
Email
arthur.hosmann@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Dorian Hirschmann, MD
First Name & Middle Initial & Last Name & Degree
Karl Roessler, MD
First Name & Middle Initial & Last Name & Degree
Fabian Winter, MD
First Name & Middle Initial & Last Name & Degree
Elisabeth Strasser, MD
First Name & Middle Initial & Last Name & Degree
Arthur Hosmann
12. IPD Sharing Statement
Plan to Share IPD
No
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Nimodipine in Vestibular Schwanommas
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