Vestibular SchwannomaRIC-VSNCT05567341
Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery
A study testing Remote ischemic preconditioning in people with Vestibular Schwannoma, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Vestibular schwannomas are primarily benign (WHO grade I) tumors originating from the Schwann cells of the vestibular nerve and are among the most common tumors of the skull base. Common treatment options are surgical tumor resection or targeted radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Schwannoma
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- total or gross-total resection of a vestibular schwannoma is planned
- Functional hearing is still present on the affected side preoperatively (AEP evocable and Gardner-Robertson grade I, II, or III).
- Preoperatively, facial function is unimpaired or mildly impaired (House and Brackmann grade I or II).
Who cannot join
- Symptomatic peripheral artery disease.
- Active or previous thrombosis in the extremity where the RIC procedure is to be performed.
- Neurofibromatosis type 2
- Only planned decompression of the internal auditory canal without relevant tumor resection
- Pregnant or breastfeeding females
- Previous radiotherapy of the vestibular schwannoma that will be resected
Trial locations and contacts
1 site in 1 country.
Constantin Roder, Prof., MD contact
Germany1 site
University Hospital Tuebingen
Tübingen, 72076
Helene V Hurth, MD, +49 7071 29 80325, helene.hurth@med.uni-tuebingen.de
Constantin Roder, Prof., MD, constantin.roder@med.uni-tuebingen.de
About this study
Official title: Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery and Its Neuroprotective Effect on the Cochlear and Facial Nerve Function
Vestibular schwannomas are primarily benign (WHO grade I) tumors originating from the Schwann cells of the vestibular nerve and are among the most common tumors of the skull base. Common treatment options are surgical tumor resection or targeted radiation therapy. The special challenge of surgical treatment is the functional preservation of the cranial nerves, especially the cochlear and facial nerves. Perioperative ischemia of the cochlea and cochlear nerve is postulated as the underlying mechanism of postoperative hearing loss. Ischemic preconditioning is a non-invasive procedure that triggers the release of vasoactive cytokines and mediators by repeated short-term induction of limb ischemia. Improved perfusion of critically perfused end organs as well as a reduction of cerebral infarct volumes has already been shown in other pathologies. In the planned study, possible neuroprotective effects of remote ischemic preconditioning on postoperative hearing as well as facial nerve function in patients with vestibular schwannomas will be examined.
Read the detailed description
Purpose: Does remote ischemic preconditioning improve hearing and/or facial nerve palsy after resection of vestibular schwannomas?
Study Design: Prospective, randomized, double-blind, single-center.
Case number: The study should include 120 patients (60 treatment arm, 60 control arm). Case number calculation (mean effect sizes, chi-square test, alpha error = 0.05, beta error = 20%) results in a necessary total patient number of 100 with 50 patients per group. Including the expected dropout rate (approx. 20%), the required total number of study participants is set at 120 patients. With approximately 55 patients/year in whom anatomic preservation of the cochlear nerve is possible intraoperatively, the total study duration is estimated to be approximately 2-2.5 years.
Study procedure: Day 1
- Preoperative pure tone audiometry including speech discrimination and preoperative AEP measurement
- preoperative assessment of facial nerve function according to House and Brackmann and photo documentation
- Preoperative blood sample (Hg, WBC, platelet count, creatinine, sodium, potassium, CRP, PCT, IL-6, INR, Quick, aPTT, d-dimer)
- Evaluation of inclusion and exclusion criteria, informed consent
Day 2
- Randomization
- At skin incision RIC procedure or sham control.
- RIC arm: 5 minutes inflation of a blood pressure cuff to 200mmHg on the right arm, then 5 minutes rest, the procedure will be performed 4 times in total.
- Control arm: 5 minutes inflation of a blood pressure cuff to 0mmHg on the right arm, then 5 minutes rest, the procedure will be performed 4 times in total.
- Performance of tumor resection under electrophysiological monitoring.
- blood sample (Hg, WBC, platelet count, creatinine, sodium, potassium, CRP, PCT, IL-6, INR, Quick, aPTT, d-dimer)
Day 3
- blood sample (Hg, WBC, platelet count, creatinine, sodium, potassium, CRP, PCT, IL-6, INR, Quick, aPTT, d-dimer)
- Clinical assessment of facial nerve function
- Evaluation of complications
Before discharge
- Clinical assessment of facial nerve function and photo documentation
- Evaluation of complications occurring in the course of the procedure
- Postoperative AEP measurement and pure tone audiometry incl. speech discrimination
Outpatient follow-up after 3 months
- Evaluation of postoperative pure tone audiometry incl. speech discrimination
- Clinical assessment of facial nerve function and photo documentation
Objective:
Primary outcome: patients undergoing RIC will show better hearing 3 months postoperatively than the sham control group.
Secondary outcome hypothesis: patients undergoing RIC will show better postoperative facial nerve function than the sham control group before discharge and 3 months postoperatively.
- Conditions
- Vestibular Schwannoma
- Being tested
- Remote ischemic preconditioning, Sham-control
- Keywords
- remote ischemic preconditioning, cochlear nerve, facial nerve, hearing, vestibular schwannoma surgery
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningProcedure or surgery
A blood pressure cuff is inflated to 200 mmHg for 4x5 min (5 min rest between cycles) at the right upper extremity when the vestibular schwannoma surgery is started
Sham-controlProcedure or surgery
A blood pressure cuff is inflated to 0 mmHg for 4x5 min (5 min rest between cycles) at the right upper extremity when the vestibular schwannoma surgery is started
| Study group | Role | What they receive |
|---|---|---|
| RIC | Experimental | On the right upper extremity a blood pressure cuff is inflated to 200mmHg for 4x5min at the beginning of the surgery Receives: Procedure: Remote ischemic preconditioning |
| Control | Sham comparator | On the right upper extremity a blood pressure cuff is inflated to 0mmHg for 4x5min at the beginning of the surgery Receives: Procedure: Sham-control |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative hearing
hearing on pure tone audiometry according to AAO-HNS/Gardner-Robertson
Measured: 3 months (± 6 weeks) after surgery
Secondary outcomes (2)
postoperative facial nerve function
facial nerve function according to House and Brackmann
Measured: up to 8 days after surgery
postoperative facial nerve function
facial nerve function according to House and Brackmann
Measured: 3 months (± 6 weeks) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group 1: intervention, remote ischemic preconditioning for 4x5 minutes at the beginning of the surgery group 2: sham-control (4x5 min without compression of the extremity)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Contantin Roder, Prof., MD, Principal investigator, Department of Neurosurgery TuebingenHelene V Hurth, MD, Principal investigator, Department of Neurosurgery Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567341
- Sponsor's protocol ID
- 489-0-0
- Acronym
- RIC-VS
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD may be shared on request after completion of the study and as soon as data will be published.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery and Its Neuroprotective Effect on the Cochlear and Facial Nerve Function
- ClinicalTrials.gov ID
- NCT05567341
- Acronym / sponsor ID
- RIC-VS / 489-0-0
- Conditions
- Vestibular Schwannoma
- Keywords
- remote ischemic preconditioning, cochlear nerve, facial nerve, hearing, vestibular schwannoma surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vestibular schwannomas are primarily benign (WHO grade I) tumors originating from the Schwann cells of the vestibular nerve and are among the most common tumors of the skull base. Common treatment options are surgical tumor resection or targeted radiation therapy. The special challenge of surgical treatment is the functional preservation of the cranial nerves, especially the cochlear and facial nerves. Perioperative ischemia of the cochlea and cochlear nerve is postulated as the underlying mechanism of postoperative hearing loss. Ischemic preconditioning is a non-invasive procedure that triggers the release of vasoactive cytokines and mediators by repeated short-term induction of limb ischemia. Improved perfusion of critically perfused end organs as well as a reduction of cerebral infarct volumes has already been shown in other pathologies. In the planned study, possible neuroprotective effects of remote ischemic preconditioning on postoperative hearing as well as facial nerve function in patients with vestibular schwannomas will be examined.
Detailed description
Purpose: Does remote ischemic preconditioning improve hearing and/or facial nerve palsy after resection of vestibular schwannomas?
Study Design: Prospective, randomized, double-blind, single-center.
Case number: The study should include 120 patients (60 treatment arm, 60 control arm). Case number calculation (mean effect sizes, chi-square test, alpha error = 0.05, beta error = 20%) results in a necessary total patient number of 100 with 50 patients per group. Including the expected dropout rate (approx. 20%), the required total number of study participants is set at 120 patients. With approximately 55 patients/year in whom anatomic preservation of the cochlear nerve is possible intraoperatively, the total study duration is estimated to be approximately 2-2.5 years.
Study procedure: Day 1
- Preoperative pure tone audiometry including speech discrimination and preoperative AEP measurement
- preoperative assessment of facial nerve function according to House and Brackmann and photo documentation
- Preoperative blood sample (Hg, WBC, platelet count, creatinine, sodium, potassium, CRP, PCT, IL-6, INR, Quick, aPTT, d-dimer)
- Evaluation of inclusion and exclusion criteria, informed consent
Day 2
- Randomization
- At skin incision RIC procedure or sham control.
- RIC arm: 5 minutes inflation of a blood pressure cuff to 200mmHg on the right arm, then 5 minutes rest, the procedure will be performed 4 times in total.
- Control arm: 5 minutes inflation of a blood pressure cuff to 0mmHg on the right arm, then 5 minutes rest, the procedure will be performed 4 times in total.
- Performance of tumor resection under electrophysiological monitoring.
- blood sample (Hg, WBC, platelet count, creatinine, sodium, potassium, CRP, PCT, IL-6, INR, Quick, aPTT, d-dimer)
Day 3
- blood sample (Hg, WBC, platelet count, creatinine, sodium, potassium, CRP, PCT, IL-6, INR, Quick, aPTT, d-dimer)
- Clinical assessment of facial nerve function
- Evaluation of complications
Before discharge
- Clinical assessment of facial nerve function and photo documentation
- Evaluation of complications occurring in the course of the procedure
- Postoperative AEP measurement and pure tone audiometry incl. speech discrimination
Outpatient follow-up after 3 months
- Evaluation of postoperative pure tone audiometry incl. speech discrimination
- Clinical assessment of facial nerve function and photo documentation
Objective:
Primary outcome: patients undergoing RIC will show better hearing 3 months postoperatively than the sham control group.
Secondary outcome hypothesis: patients undergoing RIC will show better postoperative facial nerve function than the sham control group before discharge and 3 months postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- group 1: intervention, remote ischemic preconditioning for 4x5 minutes at the beginning of the surgery group 2: sham-control (4x5 min without compression of the extremity)
| Arm | Type | Receives |
|---|---|---|
| RIC | Experimental | Procedure: Remote ischemic preconditioningOn the right upper extremity a blood pressure cuff is inflated to 200mmHg for 4x5min at the beginning of the surgery |
| Control | Sham comparator | Procedure: Sham-controlOn the right upper extremity a blood pressure cuff is inflated to 0mmHg for 4x5min at the beginning of the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- total or gross-total resection of a vestibular schwannoma is planned
- Functional hearing is still present on the affected side preoperatively (AEP evocable and Gardner-Robertson grade I, II, or III).
- Preoperatively, facial function is unimpaired or mildly impaired (House and Brackmann grade I or II).
Key exclusion criteria (6 listed)
- Symptomatic peripheral artery disease.
- Active or previous thrombosis in the extremity where the RIC procedure is to be performed.
- Neurofibromatosis type 2
- Only planned decompression of the internal auditory canal without relevant tumor resection
- Pregnant or breastfeeding females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic preconditioningA blood pressure cuff is inflated to 200 mmHg for 4x5 min (5 min rest between cycles) at the right upper extremity when the vestibular schwannoma surgery is started | Procedure or surgery | RIC |
| Sham-controlA blood pressure cuff is inflated to 0 mmHg for 4x5 min (5 min rest between cycles) at the right upper extremity when the vestibular schwannoma surgery is started | Procedure or surgery | Control |
Primary outcome
postoperative hearing
Time frame: 3 months (± 6 weeks) after surgery
hearing on pure tone audiometry according to AAO-HNS/Gardner-Robertson
2 secondary outcomes
postoperative facial nerve function
Time frame: up to 8 days after surgery
postoperative facial nerve function
Time frame: 3 months (± 6 weeks) after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Individual participant dataSharing planned: No. IPD may be shared on request after completion of the study and as soon as data will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constantin Roder, Prof., MD contact
Contantin Roder, Prof., MD principal investigator
Department of Neurosurgery Tuebingen
Helene V Hurth, MD principal investigator
Department of Neurosurgery Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning in people with Vestibular Schwannoma, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helene V Hurth, MD (+49 7071 29 80325, helene.hurth@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative hearing (time frame: 3 months (± 6 weeks) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.