ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 109 for:    "Schwannoma"

Vestibular Evaluation After Vestibular Schwannoma Treatment (EVTSVCGEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03670589
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
EssaiClinique_EVTSVCGEC, 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).


Condition or disease Intervention/treatment
Dizziness Radiation: Radiosurgery gammaknife Procedure: Microsurgery resection

Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Vestibular Evaluation Before and After Treatment of Vestibular Schwannoma. Comparison of Gamma Knife Radiosurgery and Microsurgical Resection
Actual Study Start Date : June 28, 2018
Actual Primary Completion Date : August 24, 2018
Actual Study Completion Date : August 24, 2018


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670589


Locations
France
CHU Grenoble-Alpes
La Tronche, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble

Publications:
Responsible Party: EssaiClinique_EVTSVCGEC, Vestibular Evaluation Before and After Treatment of Vestibular Schwannoma. Comparison of Gamma Knife Radiosurgery and Microsurgical Resection., University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03670589     History of Changes
Other Study ID Numbers: 38RC18.098
2018-A01208-47 ( Other Identifier: ID RCB )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by EssaiClinique_EVTSVCGEC, University Hospital, Grenoble:
vestibular schwannoma
gammaknife radiosurgery
vestibular evaluation

Additional relevant MeSH terms:
Neurilemmoma
Dizziness
Neuroma, Acoustic
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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