Vestibular Evaluation After Vestibular Schwannoma Treatment

NCT03670589 | Completed

• 2 other identifiers: 38RC18.0982018-A01208-47
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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).

Conditions

Dizziness

Keywords

vestibular schwannoma; gammaknife radiosurgery; vestibular evaluation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Facial fonction

  From 4 years to 6 months

• Hearing function

  From 4 years to 6 months

• Tumor control

  From 4 years to 6 months

Study Arms (2)

radiosurgery gammaknife group

Patient treated by radiosurgery gammaknife for a one side vestibular schwannoma

Radiation: Radiosurgery gammaknife

microsurgery resection group

Patient treated by microsurgery resection for a one side vestibular schwannoma

Procedure: Microsurgery resection

Interventions

Radiosurgery gammaknife RADIATION

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

radiosurgery gammaknife group

Microsurgery resection PROCEDURE

Classical surgical approach with oto-neurosurgery procedures

microsurgery resection group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• association of gamaknife radiosurgery and microsurgery resection
• bilateral vestibular schwannoma

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble-Alpes

La Tronche, 38700, France

Location

Related Publications (4)

• 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.

  PMID: 25273693 BACKGROUND

• 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.

  PMID: 21479879 BACKGROUND

• 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.

  PMID: 16823303 BACKGROUND

• 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.

  PMID: 18849856 BACKGROUND

MeSH Terms

Conditions

Dizziness; Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurilemmoma; 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; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vestibular Evaluation Before and After Treatment of Vestibular Schwannoma. Comparison of Gamma Knife Radiosurgery and Microsurgical Resection.

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: September 13, 2018
• Study Start: June 28, 2018
• Primary Completion: August 24, 2018
• Study Completion: August 24, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)