Vestibular Evaluation After Vestibular Schwannoma Treatment (EVTSVCGEC)

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ClinicalTrials.gov Identifier: NCT03670589

Recruitment Status : Completed

First Posted : September 13, 2018

Last Update Posted : September 13, 2018

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

EssaiClinique_EVTSVCGEC, University Hospital, Grenoble

Study Description

Brief 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.

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).

Condition or disease	Intervention/treatment
Dizziness	Radiation: Radiosurgery gammaknife Procedure: Microsurgery resection

Study Design

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Study Type :	Observational
Actual Enrollment :	51 participants
Observational Model:	Case-Control
Time Perspective:	Retrospective
Official Title:	Vestibular Evaluation Before and After Treatment of Vestibular Schwannoma. Comparison of Gamma Knife Radiosurgery and Microsurgical Resection
Actual Study Start Date :	June 28, 2018
Actual Primary Completion Date :	August 24, 2018
Actual Study Completion Date :	August 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acoustic Neuroma Dizziness and Vertigo

Genetic and Rare Diseases Information Center resources: Schwannoma Acoustic Neuroma Neuroendocrine Tumor Neuroepithelioma

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
radiosurgery gammaknife group Patient treated by radiosurgery gammaknife for a one side vestibular schwannoma	Radiation: Radiosurgery gammaknife 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 resection group Patient treated by microsurgery resection for a one side vestibular schwannoma	Procedure: Microsurgery resection Classical surgical approach with oto-neurosurgery procedures

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

Facial fonction [ Time Frame: From 4 years to 6 months ]
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.
Hearing function [ Time Frame: From 4 years to 6 months ]
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.
Tumor control [ Time Frame: From 4 years to 6 months ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

association of gamaknife radiosurgery and microsurgery resection
bilateral vestibular schwannoma

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670589

Locations

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France
CHU Grenoble-Alpes
La Tronche, France, 38700

Sponsors and Collaborators

University Hospital, Grenoble

More Information

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.

Park 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.

Pollock 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.

Coelho 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.

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Responsible Party:	EssaiClinique_EVTSVCGEC, Vestibular Evaluation Before and After Treatment of Vestibular Schwannoma. Comparison of Gamma Knife Radiosurgery and Microsurgical Resection., University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT03670589
Other Study ID Numbers:	38RC18.098 2018-A01208-47 ( Other Identifier: ID RCB )
First Posted:	September 13, 2018 Key Record Dates
Last Update Posted:	September 13, 2018
Last Verified:	September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by EssaiClinique_EVTSVCGEC, University Hospital, Grenoble:


vestibular schwannoma gammaknife radiosurgery vestibular evaluation

Additional relevant MeSH terms:

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Neurilemmoma Neuroma, Acoustic Dizziness Sensation Disorders Neurologic Manifestations Ear Diseases Otorhinolaryngologic Diseases Nervous System Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type	Neoplasms Neuroma Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Cranial Nerve Neoplasms Nervous System Neoplasms Neoplasms by Site Peripheral Nervous System Neoplasms Vestibulocochlear Nerve Diseases Retrocochlear Diseases Otorhinolaryngologic Neoplasms Cranial Nerve Diseases

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