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Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma (ITG)

Primary Purpose

Vestibular Schwannoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gentamicin
Sponsored by
University Hospital, Motol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vestibular Schwannoma focused on measuring vestibular rehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of vestibular schwannoma
  • hearing loss on affected side
  • preserved vestibular reactivity of labyrinths on the affected side

Exclusion Criteria:

  • allergy to gentamicin
  • vestibular areflexia on the affected side

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    gentamicin

    Arm Description

    intratympanic application of gentamicin 0.5 ml

    Outcomes

    Primary Outcome Measures

    The GBI questionnaire
    The GBI questionnaire consists of 18 questions. The response to each question is based on a five-point Likert scale, ranging from a large deterioration to a large improvement in health status. The GBI questionnaire is scored into a total score, and also three subscales: a general subscale (12 questions), a social support subscale (three questions), and a physical health subscale (three questions). Score ranges were calculated and varied from -100 to +100. Score all questions so that a score of 1 is given to the answer with the worst change in health status and 5 to the answer with the best change in health status.
    The GHSI questionnaire
    The GHSI questionnaire contains of 18 questions; again, the response to each question is based on a five-point Likert scale ranging from high to low health status. It is also scored into a total score and three subscales: general, social, and physical health subscales. All these scores range from 0 to +100. Score all questions so that a score of 1 is given to the answer with the worst change in health status and 5 to the answer with the best change in health status.
    The DHI questionnaire
    The DHI contains 25 items and the range score is from 0 to +100, with a higher score indicating a more severe handicap.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 2016
    Last Updated
    November 14, 2016
    Sponsor
    University Hospital, Motol
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02963896
    Brief Title
    Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma
    Acronym
    ITG
    Official Title
    Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma With Pretreatment Prehabituation by Chemical Vestibular Ablation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Motol

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Surgical removal of vestibular schwannoma causes acute vestibular symptoms, including postoperative vertigo and oscilopsia due to nystagmus. In general, the dominant symptom postoperatively is vertigo. Preoperative chemical vestibular ablation can reduce vestibular symptoms postoperatively.
    Detailed Description
    Surgical removal of vestibular schwannoma causes acute vestibular symptoms, including postoperative vertigo and oscilopsia due to nystagmus. In general, the dominant symptom postoperatively is vertigo. Preoperative chemical vestibular ablation can reduce vestibular symptoms postoperatively. We used 1.0 ml of 40 mg/ml nonbuffered gentamicin in three intratympanic installations over 2 days, 2 months preoperatively in 10 patients. Reduction of vestibular function was measured by the head impulse test and the caloric test. Reduction of vestibular function was found in all gentamicin patient groups. After gentamicin vestibular ablation, patients underwent home vestibular exercising for two months. The control group consisted of 10 patients who underwent only home vestibular training two months preoperatively. Postoperative rate of recovery and vertigo in both groups were evaluated with the Glasgow Benefit Inventory (GBI), the Glasgow Health Status Inventory (GHSI) and the Dizziness Handicap Inventory questionnaires, as well as survey of visual symptoms by specific questionnaire developed by us.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vestibular Schwannoma
    Keywords
    vestibular rehabilitation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    gentamicin
    Arm Type
    Experimental
    Arm Description
    intratympanic application of gentamicin 0.5 ml
    Intervention Type
    Drug
    Intervention Name(s)
    gentamicin
    Other Intervention Name(s)
    gentamycin
    Intervention Description
    intratympanic application of gentamicin 2m/80mg - 3x application -0,5 ml
    Primary Outcome Measure Information:
    Title
    The GBI questionnaire
    Description
    The GBI questionnaire consists of 18 questions. The response to each question is based on a five-point Likert scale, ranging from a large deterioration to a large improvement in health status. The GBI questionnaire is scored into a total score, and also three subscales: a general subscale (12 questions), a social support subscale (three questions), and a physical health subscale (three questions). Score ranges were calculated and varied from -100 to +100. Score all questions so that a score of 1 is given to the answer with the worst change in health status and 5 to the answer with the best change in health status.
    Time Frame
    2-3 years
    Title
    The GHSI questionnaire
    Description
    The GHSI questionnaire contains of 18 questions; again, the response to each question is based on a five-point Likert scale ranging from high to low health status. It is also scored into a total score and three subscales: general, social, and physical health subscales. All these scores range from 0 to +100. Score all questions so that a score of 1 is given to the answer with the worst change in health status and 5 to the answer with the best change in health status.
    Time Frame
    2-3 years
    Title
    The DHI questionnaire
    Description
    The DHI contains 25 items and the range score is from 0 to +100, with a higher score indicating a more severe handicap.
    Time Frame
    2-3 years

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: clinical diagnosis of vestibular schwannoma hearing loss on affected side preserved vestibular reactivity of labyrinths on the affected side Exclusion Criteria: allergy to gentamicin vestibular areflexia on the affected side
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zdeněk Čada, Ph.D.
    Organizational Affiliation
    Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University in Prague and Motol University Hospital, Postgraduate Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    7603726
    Citation
    Herdman SJ, Clendaniel RA, Mattox DE, Holliday MJ, Niparko JK. Vestibular adaptation exercises and recovery: acute stage after acoustic neuroma resection. Otolaryngol Head Neck Surg. 1995 Jul;113(1):77-87. doi: 10.1016/s0194-5998(95)70148-6.
    Results Reference
    background
    PubMed Identifier
    28053986
    Citation
    Cada Z, Balatkova Z, Chovanec M, Cakrt O, Hruba S, Jerabek J, Zverina E, Profant O, Fik Z, Komarc M, Betka J, Kluh J, Cerny R. Vertigo Perception and Quality of Life in Patients after Surgical Treatment of Vestibular Schwannoma with Pretreatment Prehabituation by Chemical Vestibular Ablation. Biomed Res Int. 2016;2016:6767216. doi: 10.1155/2016/6767216. Epub 2016 Dec 8.
    Results Reference
    derived

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    Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma

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