Vestibular Evaluation After Vestibular Schwannoma Treatment

Completed

• Conditions: Dizziness
• Interventions: Procedure: Microsurgery resection; Radiation: Radiosurgery gammaknife

• Registration Number: NCT03670589
• Lead Sponsor: University Hospital, Grenoble

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-28
• Primary Completion: 2018-08-24
• Study Completion: 2018-08-24
• Study First Submitted: 2018-08-24
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-12
• Last Update Submitted: 2018-09-12
• Study First Posted: 2018-09-13
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
microsurgery resection group	Microsurgery resection	Patient treated by microsurgery resection for a one side vestibular schwannoma
radiosurgery gammaknife group	Radiosurgery gammaknife	Patient treated by radiosurgery gammaknife for a one side vestibular schwannoma

Primary Outcome Measures

Name	Time	Method
Vestibular evaluation DHI	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	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

Name	Time	Method
Tumor control	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.
Facial fonction	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	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.

Trial Locations

Locations (1)

CHU Grenoble-Alpes; 🇫🇷 La Tronche, France