Vestibular SchwannomaReveSTANNCT02275325
Preoperative Vestibular Rehabilitation Effectiveness After Vestibular Schwannoma Surgery
A study testing Preoperative vestibular rehabilitation in people with Vestibular Schwannoma, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Vestibular schwannoma (VS) is a benign tumour from Schwann cells surrounding the vestibular nerve, which slowly grows within the internal auditory canal and then into the cerebellopontine angle, leading to a gradual vestibular dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vestibular Schwannoma
- What is being tested?
- Preoperative vestibular rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Apr 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unilateral vestibular schwannoma (stage I to IV according to the Koos classification) with an indication for surgery.
- Patients gave their written informed consent
- Patients are affiliated to the french social welfare
Who cannot join
- Disorders from the motor and/or somesthetic systems (especially the lower limbs)
- Contraindications to the scheduled functional assessments: ear pathology different from vestibular schwannoma such as cholesteatoma of the middle ear, tympanic membrane perforation, etc.
- Refusal of the surgical procedure
Trial locations and contacts
1 site in 1 country.
Gérome Gauchard, PhD contact
France1 site, 1 recruiting
- Recruiting
University Hospital of Nancy
Nancy, 54000
Cécile Parietti-Winkler, MD, PhD, +33 383 852 032, c.parietti@chu-nancy.fr
Gérome Gauchard, PhD, gerome.gauchard@univ-lorraine.fr
About this study
Official title: Assessment of the Preoperative Vestibular Rehabilitation Effectiveness on Balance Control Compensation After Vestibular Schwannoma Surgery
Vestibular schwannoma (VS) is a benign tumour from Schwann cells surrounding the vestibular nerve, which slowly grows within the internal auditory canal and then into the cerebellopontine angle, leading to a gradual vestibular dysfunction. The slowly progressive alteration of vestibular function allows the gradual implementation of central adaptive mechanisms called vestibular compensation. The total unilateral vestibular deafferentation induced by the surgical tumour removal suddenly leads to a decompensation of this previously compensated situation, which explains why most patients report severe vertigo immediately after surgery and which is responsible for perturbations of the postural control (Parietti-Winkler et al., 2006, 2008, 2010, 2011). Recently, Gauchard et al. (2013) suggested that preoperative and regular physical activity would limit the adverse effects of surgical removal on balance control. Also, patients benefited faster and better from the postoperative vestibular rehabilitation.
Thus, preoperative vestibular rehabilitation, including physical and balance exercises, could help to limit postoperative balance disorders and promote postoperative balance compensation. This could lead to a decrease in the duration and cost of the postoperative management and faster improvement of quality of life.
Read the detailed description
To test this hypothesis, the measured and perceived balance control of the patient and the quality of life will be assessed into two groups: one of two groups will receive preoperative vestibular rehabilitation, carried out by a physiotherapist, and the other not. The assessments will be conducted 45 days and 3 days before surgery, and then 8 days, 30 days, 90 days and 365 days after surgery.
- Conditions
- Vestibular Schwannoma
- Being tested
- Preoperative vestibular rehabilitation
- Keywords
- Posture, Unilateral vestibular deafferentation, Medical management, Preoperative vestibular rehabilitation, Neural plasticity
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative vestibular rehabilitationOther
12 one-hour sessions with exercises of balance on unstable conditions (foam, tilt of the platform, biofeedback)
| Study group | Role | What they receive |
|---|---|---|
| Preoperative rehabilitation | Experimental | Patients that have a preoperative vestibular rehabilitation before vestibular schwannoma surgery in addition to the usual postoperative vestibular rehabilitation Receives: Other: Preoperative vestibular rehabilitation |
| Usual | No intervention | Group of patients that solely have a postoperative vestibular rehabilitation after vestibular schwannoma surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute balance compensation
Change in composite equilibrium score from baseline to 8 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and the composite equilibrium (in %) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA).
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: One week after surgery
Secondary outcomes (17)
Balance compensation at short term
Change in composite equilibrium score from baseline to 30 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and the composite equilibrium (in %) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA).
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: One month after surgery
Balance compensation at middle term
Change in composite equilibrium score from baseline to 90 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and the composite equilibrium (in %) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA).
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: Three months after surgery
Balance compensation at long term
Change in composite equilibrium score from baseline to 365 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and the composite equilibrium (in %) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA).
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: One year after surgery
Preoperative balance compensation
Change in composite equilibrium score from baseline to three days before surgery. The baseline corresponds to the day before the preoperative rehabilitation and the composite equilibrium (in %) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA).
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: From baseline to three days before surgery
Acute change in self-rated dizziness (measured with the Dizziness Handicap Inventory)
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) from baseline to 8 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation.
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: One week after surgery
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at short term
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) from baseline to 30 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation.
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: One month after surgery
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at middle term
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) from baseline to 90 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation.
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: Three months after surgery
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at long term
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) from baseline to 365 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation.
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: One year after surgery
Acute change in self-rated quality of life (measured with WHOQOL-Bref questionnaire)
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) from baseline to 8 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation.
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: One week after surgery
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at short term
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) from baseline to 30 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation.
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: One month after surgery
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at middle term
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) from baseline to 90 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation.
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: Three months after surgery
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at long term
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) from baseline to 365 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation.
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: One year after surgery
Acute change in vestibular function
Change in vestibular function (measured by means of videonystagmography) from baseline to 8 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and videonystagmographic tests include both pendular and caloric tests.
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: One week after surgery
Change in vestibular function at short term
Change in vestibular function (measured by means of videonystagmography) from baseline to 30 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and videonystagmographic tests include both pendular and caloric tests.
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: One month after surgery
Change in vestibular function at middle term
Change in vestibular function (measured by means of videonystagmography) from baseline to 90 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and videonystagmographic tests include both pendular and caloric tests.
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: Three months after surgery
Change in vestibular function at long term
Change in vestibular function (measured by means of videonystagmography) from baseline to 365 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and videonystagmographic tests include both pendular and caloric tests.
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: One year after surgery
Preoperative change in vestibular function
Change in vestibular function (measured by means of videonystagmography) from baseline to three days before surgery. The baseline corresponds to the day before the preoperative rehabilitation and videonystagmographic tests include both pendular and caloric tests.
Comparison between both groups (preoperative rehabilitation vs. usual).
Measured: From baseline to three days before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionApr 2018 (estimated)
- Study completionApr 2019 (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 Central Hospital, Nancy, FranceThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine
- Responsible party
- Principal investigator, Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France
- Investigators
- Cécile Parietti-Winkler, MD, PhD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275325
- Sponsor's protocol ID
- 2014-A01189-38
- Other IDs
- 140989B-31
- Acronym
- ReveSTAN
- Status last verified
- Jun 2016
- First submitted
- 17 Oct 2014
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Preoperative Vestibular Rehabilitation Effectiveness on Balance Control Compensation After Vestibular Schwannoma Surgery
- ClinicalTrials.gov ID
- NCT02275325
- Acronym / sponsor ID
- ReveSTAN / 2014-A01189-38
- Conditions
- Vestibular Schwannoma
- Keywords
- Posture, Unilateral vestibular deafferentation, Medical management, Preoperative vestibular rehabilitation, Neural plasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University of Lorraine
- Study start
- Jan 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 27 Oct 2014 (estimated)
- 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 schwannoma (VS) is a benign tumour from Schwann cells surrounding the vestibular nerve, which slowly grows within the internal auditory canal and then into the cerebellopontine angle, leading to a gradual vestibular dysfunction. The slowly progressive alteration of vestibular function allows the gradual implementation of central adaptive mechanisms called vestibular compensation. The total unilateral vestibular deafferentation induced by the surgical tumour removal suddenly leads to a decompensation of this previously compensated situation, which explains why most patients report severe vertigo immediately after surgery and which is responsible for perturbations of the postural control (Parietti-Winkler et al., 2006, 2008, 2010, 2011). Recently, Gauchard et al. (2013) suggested that preoperative and regular physical activity would limit the adverse effects of surgical removal on balance control. Also, patients benefited faster and better from the postoperative vestibular rehabilitation.
Thus, preoperative vestibular rehabilitation, including physical and balance exercises, could help to limit postoperative balance disorders and promote postoperative balance compensation. This could lead to a decrease in the duration and cost of the postoperative management and faster improvement of quality of life.
Detailed description
To test this hypothesis, the measured and perceived balance control of the patient and the quality of life will be assessed into two groups: one of two groups will receive preoperative vestibular rehabilitation, carried out by a physiotherapist, and the other not. The assessments will be conducted 45 days and 3 days before surgery, and then 8 days, 30 days, 90 days and 365 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative rehabilitation | Experimental | Other: Preoperative vestibular rehabilitationPatients that have a preoperative vestibular rehabilitation before vestibular schwannoma surgery in addition to the usual postoperative vestibular rehabilitation |
| Usual | No intervention | –Group of patients that solely have a postoperative vestibular rehabilitation after vestibular schwannoma surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with unilateral vestibular schwannoma (stage I to IV according to the Koos classification) with an indication for surgery.
- Patients gave their written informed consent
- Patients are affiliated to the french social welfare
Key exclusion criteria (3 listed)
- Disorders from the motor and/or somesthetic systems (especially the lower limbs)
- Contraindications to the scheduled functional assessments: ear pathology different from vestibular schwannoma such as cholesteatoma of the middle ear, tympanic membrane perforation, etc.
- Refusal of the surgical procedure
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 |
|---|---|---|
| Preoperative vestibular rehabilitation12 one-hour sessions with exercises of balance on unstable conditions (foam, tilt of the platform, biofeedback) | Other | Preoperative rehabilitation |
Primary outcome
Acute balance compensation
Time frame: One week after surgery
Change in composite equilibrium score from baseline to 8 days after surgery. The baseline corresponds to the day before the preoperative rehabilitation and the composite equilibrium (in %) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA). Comparison between both groups (preoperative rehabilitation vs. usual).
17 secondary outcomes
Balance compensation at short term
Time frame: One month after surgery
Balance compensation at middle term
Time frame: Three months after surgery
Balance compensation at long term
Time frame: One year after surgery
Preoperative balance compensation
Time frame: From baseline to three days before surgery
Acute change in self-rated dizziness (measured with the Dizziness Handicap Inventory)
Time frame: One week after surgery
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at short term
Time frame: One month after surgery
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at middle term
Time frame: Three months after surgery
Change in self-rated dizziness (measured with the Dizziness Handicap Inventory) at long term
Time frame: One year after surgery
Acute change in self-rated quality of life (measured with WHOQOL-Bref questionnaire)
Time frame: One week after surgery
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at short term
Time frame: One month after surgery
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at middle term
Time frame: Three months after surgery
Change in self-rated quality of life (measured with WHOQOL-Bref questionnaire) at long term
Time frame: One year after surgery
Acute change in vestibular function
Time frame: One week after surgery
Change in vestibular function at short term
Time frame: One month after surgery
Change in vestibular function at middle term
Time frame: Three months after surgery
Change in vestibular function at long term
Time frame: One year after surgery
Preoperative change in vestibular function
Time frame: From baseline to three days before surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
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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.
Gérome Gauchard, PhD contact
Cécile Parietti-Winkler, MD, PhD principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative vestibular rehabilitation in people with Vestibular Schwannoma, run by Central Hospital, Nancy, France at 1 site in France.
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 3 inclusion and 3 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 21 Jun 2016. 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 France. 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. 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 Cécile Parietti-Winkler, MD, PhD (+33 383 852 032, c.parietti@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute balance compensation (time frame: One week 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 21 Jun 2016.