Vestibular Evaluation After Vestibular Schwannoma Treatment (EVTSVCGEC)

September 12, 2018 updated by: EssaiClinique_EVTSVCGEC, University Hospital, Grenoble

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France, 38700
        • CHU Grenoble-Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From 4 years to 6 months
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.
From 4 years to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From 4 years to 6 months
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.
From 4 years to 6 months
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.
From 4 years to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 28, 2018

Primary Completion (ACTUAL)

August 24, 2018

Study Completion (ACTUAL)

August 24, 2018

Study Registration Dates

First Submitted

August 24, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (ACTUAL)

September 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC18.098
  • 2018-A01208-47 (OTHER: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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