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NCT Number: NCT03670589

Vestibular Evaluation After Vestibular Schwannoma Treatment

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble-Alpes

La Tronche, 38700, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Microsurgery resection

Procedure

Classical surgical approach with oto-neurosurgery procedures

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: EVTSVCGEC

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2018
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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