DizzinessEVTSVCGECNCT03670589
Vestibular Evaluation After Vestibular Schwannoma Treatment
An observational study of Dizziness, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Vestibular schwannoma is a benign tumor located on the vestibular nerve. Patient could present dizziness symptoms cause to the tumor, and at least after the treatment by gamaknife radiosurgery or microsurgery resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dizziness
- What is being tested?
- Radiosurgery gammaknife and Microsurgery resection
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2018to 24 Aug 2018
- Phase
- Observational
- 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
Study population: The popultaion include patients treated by gamaknife radiosurgery or microsurgery resection for a one side vestibular schwannoma between 01/01/2012 and 31/12/2017, follow at the Grenoble University Hospital
Who may be able to join
- patient treated of an one side vestibular schwannoma between 01/01/2012 and 31/12/2017, follow at the Grenoble University Hospital
- treatment : gamaknife radiosurgery or microsurgery resection
- no opposition of the patient
Who cannot join
- association of gamaknife radiosurgery and microsurgery resection
- bilateral vestibular schwannoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vestibular Evaluation Before and After Treatment of Vestibular Schwannoma. Comparison of Gamma Knife Radiosurgery and Microsurgical Resection
Vestibular schwannoma is a benign tumor located on the vestibular nerve. Patient could present dizziness symptoms cause to the tumor, and at least after the treatment by gamaknife radiosurgery or microsurgery resection.
Only few studies keep the interest about dizziness symptoms and treatment modality in vestibular schwannoma.
In the study dizziness symptoms were compared before and after the treatment of vestibular schwannoma by radiosurgery gammaknife or microsurgery resection. 2 scales were used : dizziness handicap inventory (DHI) and dizziness functionnal scale (AAO).
- Conditions
- Dizziness
- Being tested
- Radiosurgery gammaknife, Microsurgery resection
- Keywords
- vestibular schwannoma, gammaknife radiosurgery, vestibular evaluation
- Medical subject headings
- Dizziness, Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiosurgery gammaknifeRadiation
This procedure use intense gamma ray, which are concentrated to the precise volume of the tumor that used to stop the progression of the tumor
Microsurgery resectionProcedure or surgery
Classical surgical approach with oto-neurosurgery procedures
| Study group | Role | What they receive |
|---|---|---|
| radiosurgery gammaknife group | Patient treated by radiosurgery gammaknife for a one side vestibular schwannoma Receives: Radiation: Radiosurgery gammaknife | |
| microsurgery resection group | Patient treated by microsurgery resection for a one side vestibular schwannoma Receives: Procedure: Microsurgery resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular evaluation DHI
The investigator use a standarised scale :
- Dizziness Handicap Inventory (DHI). This scale combines 25 questions with three answers for each proposition about dizzyness in daily life situation : everytime (quote 4), sometimes (quote 2), never (quote 0). The scores are summing to obtain a value on 100.
The scale is completed before and after the treatement. The investigator send the scale to the patient by mail way.
Measured: From 4 years to 6 months
Vestibular evaluation AAO
The investigator use a standarised scale :
- Dizziness Functionnal Scale (AAO), this is a scale quote from 1 (no symptoms of dizzyness) to 6 (major disability). The patient have to choise only one item that correspond to the condition.
The scale is completed before and after the treatement. The investigator send the scale to the patient by mail way.
Measured: From 4 years to 6 months
Secondary outcomes (3)
Facial fonction
House and Brackmann scale :
This scale is a standarised assessment of facial fonction from grade I : normal ; to grade VI : total paralysis.
Each scale is completed after the treatement.
Measured: From 4 years to 6 months
Hearing function
This information is based on a question to the patient about the usefulness of hearing prothesis.
So there are 2 groups : useful hearing (normal hearing or used hearing prothesis) or useless hearing (unsused hearing prothesis)
The information is completed before and after the treatement.
Measured: From 4 years to 6 months
Tumor control
Tumor control is based on MRI size description (in mm):
So there are 2 groups : controled or evolution of the tumor.
- for microsurgery resection group the investigator keeps interest about the remaining size
- for radiosurgery gammaknife group the investigator keeps interest about the stability or the reduction of the tumor
The result is completed after the treatement.
Measured: From 4 years to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start28 Jun 2018
- Primary completion24 Aug 2018
- Study completion24 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DizzinessStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EssaiClinique_EVTSVCGEC, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670589
- Sponsor's protocol ID
- 38RC18.098
- Other IDs
- 2018-A01208-47
- Acronym
- EVTSVCGEC
- Status last verified
- Sep 2018
- First submitted
- 24 Aug 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carlson ML, Tveiten OV, Driscoll CL, Neff BA, Shepard NT, Eggers SD, Staab JP, Tombers NM, Goplen FK, Lund-Johansen M, Link MJ. Long-term dizziness handicap in patients with vestibular schwannoma: a multicenter cross-sectional study. Otolaryngol Head Neck Surg. 2014 Dec;151(6):1028-37. doi: 10.1177/0194599814551132. Epub 2014 Oct 1.
PubMed 25273693Park CE, Park BJ, Lim YJ, Yeo SG. Functional outcomes in retrosigmoid approach microsurgery and gamma knife stereotactic radiosurgery in vestibular schwannoma. Eur Arch Otorhinolaryngol. 2011 Jul;268(7):955-9. doi: 10.1007/s00405-011-1596-9. Epub 2011 Apr 11.
PubMed 21479879Pollock BE, Driscoll CL, Foote RL, Link MJ, Gorman DA, Bauch CD, Mandrekar JN, Krecke KN, Johnson CH. Patient outcomes after vestibular schwannoma management: a prospective comparison of microsurgical resection and stereotactic radiosurgery. Neurosurgery. 2006 Jul;59(1):77-85; discussion 77-85. doi: 10.1227/01.NEU.0000219217.14930.14.
PubMed 16823303Coelho DH, Roland JT Jr, Rush SA, Narayana A, St Clair E, Chung W, Golfinos JG. Small vestibular schwannomas with no hearing: comparison of functional outcomes in stereotactic radiosurgery and microsurgery. Laryngoscope. 2008 Nov;118(11):1909-16. doi: 10.1097/MLG.0b013e31818226cb.
PubMed 18849856
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Evaluation Before and After Treatment of Vestibular Schwannoma. Comparison of Gamma Knife Radiosurgery and Microsurgical Resection
- ClinicalTrials.gov ID
- NCT03670589
- Acronym / sponsor ID
- EVTSVCGEC / 38RC18.098
- Conditions
- Dizziness
- Keywords
- vestibular schwannoma, gammaknife radiosurgery, vestibular evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 24 Aug 2018 (actual)
- First posted
- 13 Sep 2018 (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 schwannoma is a benign tumor located on the vestibular nerve. Patient could present dizziness symptoms cause to the tumor, and at least after the treatment by gamaknife radiosurgery or microsurgery resection.
Only few studies keep the interest about dizziness symptoms and treatment modality in vestibular schwannoma.
In the study dizziness symptoms were compared before and after the treatment of vestibular schwannoma by radiosurgery gammaknife or microsurgery resection. 2 scales were used : dizziness handicap inventory (DHI) and dizziness functionnal scale (AAO).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiosurgery gammaknife group | – | Radiation: Radiosurgery gammaknifePatient treated by radiosurgery gammaknife for a one side vestibular schwannoma |
| microsurgery resection group | – | Procedure: Microsurgery resectionPatient treated by microsurgery resection for a one side vestibular schwannoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The popultaion include patients treated by gamaknife radiosurgery or microsurgery resection for a one side vestibular schwannoma between 01/01/2012 and 31/12/2017, follow at the Grenoble University Hospital
Key inclusion criteria (3 listed)
- patient treated of an one side vestibular schwannoma between 01/01/2012 and 31/12/2017, follow at the Grenoble University Hospital
- treatment : gamaknife radiosurgery or microsurgery resection
- no opposition of the patient
Key exclusion criteria (2 listed)
- association of gamaknife radiosurgery and microsurgery resection
- bilateral vestibular schwannoma
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 |
|---|---|---|
| Radiosurgery gammaknifeThis procedure use intense gamma ray, which are concentrated to the precise volume of the tumor that used to stop the progression of the tumor | Radiation | radiosurgery gammaknife group |
| Microsurgery resectionClassical surgical approach with oto-neurosurgery procedures | Procedure or surgery | microsurgery resection group |
Primary outcome
Vestibular evaluation DHI
Time frame: From 4 years to 6 months
The investigator use a standarised scale : - Dizziness Handicap Inventory (DHI). This scale combines 25 questions with three answers for each proposition about dizzyness in daily life situation : everytime (quote 4), sometimes (quote 2), never (quote 0). The scores are summing to obtain a value on 100. The scale is completed before and after the treatement. The investigator send the scale to the patient by mail way.
Vestibular evaluation AAO
Time frame: From 4 years to 6 months
The investigator use a standarised scale : - Dizziness Functionnal Scale (AAO), this is a scale quote from 1 (no symptoms of dizzyness) to 6 (major disability). The patient have to choise only one item that correspond to the condition. The scale is completed before and after the treatement. The investigator send the scale to the patient by mail way.
3 secondary outcomes
Facial fonction
Time frame: From 4 years to 6 months
Hearing function
Time frame: From 4 years to 6 months
Tumor control
Time frame: From 4 years to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Background: PubMed 25273693Carlson ML, Tveiten OV, Driscoll CL, Neff BA, Shepard NT, Eggers SD, Staab JP, Tombers NM, Goplen FK, Lund-Johansen M, Link MJ. Long-term dizziness handicap in patients with vestibular schwannoma: a multicenter cross-sectional study. Otolaryngol Head Neck Surg. 2014 Dec;151(6):1028-37. doi: 10.1177/0194599814551132. Epub 2014 Oct 1.
- Background: PubMed 21479879Park CE, Park BJ, Lim YJ, Yeo SG. Functional outcomes in retrosigmoid approach microsurgery and gamma knife stereotactic radiosurgery in vestibular schwannoma. Eur Arch Otorhinolaryngol. 2011 Jul;268(7):955-9. doi: 10.1007/s00405-011-1596-9. Epub 2011 Apr 11.
- Background: PubMed 16823303Pollock BE, Driscoll CL, Foote RL, Link MJ, Gorman DA, Bauch CD, Mandrekar JN, Krecke KN, Johnson CH. Patient outcomes after vestibular schwannoma management: a prospective comparison of microsurgical resection and stereotactic radiosurgery. Neurosurgery. 2006 Jul;59(1):77-85; discussion 77-85. doi: 10.1227/01.NEU.0000219217.14930.14.
- Background: PubMed 18849856Coelho DH, Roland JT Jr, Rush SA, Narayana A, St Clair E, Chung W, Golfinos JG. Small vestibular schwannomas with no hearing: comparison of functional outcomes in stereotactic radiosurgery and microsurgery. Laryngoscope. 2008 Nov;118(11):1909-16. doi: 10.1097/MLG.0b013e31818226cb.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dizziness, run by University Hospital, Grenoble 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 2 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: finished, as of the sponsor's last update on 13 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular evaluation DHI (time frame: From 4 years to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03670589, which also lists 4 linked publications.
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 13 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.