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Trial record 3 of 4 for:    "Neuroma" | "Gentamicins"

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

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ClinicalTrials.gov Identifier: NCT02963896
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Zdeněk Čada, University Hospital, Motol

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.

Condition or disease Intervention/treatment Phase
Vestibular Schwannoma Drug: gentamicin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma With Pretreatment Prehabituation by Chemical Vestibular Ablation
Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: gentamicin
intratympanic application of gentamicin 0.5 ml
Drug: gentamicin
intratympanic application of gentamicin 2m/80mg - 3x application -0,5 ml
Other Name: gentamycin




Primary Outcome Measures :
  1. The GBI questionnaire [ Time Frame: 2-3 years ]
    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.

  2. The GHSI questionnaire [ Time Frame: 2-3 years ]
    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.

  3. The DHI questionnaire [ Time Frame: 2-3 years ]
    The DHI contains 25 items and the range score is from 0 to +100, with a higher score indicating a more severe handicap.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02963896


Sponsors and Collaborators
University Hospital, Motol
Investigators
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Principal Investigator: Zdeněk Čada, Ph.D. Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University in Prague and Motol University Hospital, Postgraduate Medical School

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zdeněk Čada, M.D., PH.D., University Hospital, Motol
ClinicalTrials.gov Identifier: NCT02963896     History of Changes
Other Study ID Numbers: 13476 FN Motol
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zdeněk Čada, University Hospital, Motol:
vestibular rehabilitation
Additional relevant MeSH terms:
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Neuroma, Acoustic
Neuroma
Gentamicins
Neurilemmoma
Vertigo
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors