Vestibular Evaluation After Vestibular Schwannoma Treatment

Dizziness Clinical Trial

— EVTSVCGEC  

Official title:

Vestibular Evaluation Before and After Treatment of Vestibular Schwannoma. Comparison of Gamma Knife Radiosurgery and Microsurgical Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670589
• Other study ID #: 38RC18.098
• Secondary ID: 2018-A01208-47
• Status: Completed
• Start date: June 28, 2018
• Est. completion date: August 24, 2018

Study information

• Verified date: September 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 24, 2018
• Est. primary completion date: August 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Neurilemmoma
• Neuroma, Acoustic

Intervention

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

Procedure:
• Microsurgery resection
Classical surgical approach with oto-neurosurgery procedures

Locations

Country	Name	City	State
France	CHU Grenoble-Alpes	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (4)

Carlson ML, Tveiten ØV, 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From 4 years to 6 months
Primary	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.	From 4 years to 6 months
Secondary	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.	From 4 years to 6 months
Secondary	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.	From 4 years to 6 months
Secondary	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.	From 4 years to 6 months