NCT02963896

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

1.9 years

First QC Date

November 1, 2016

Last Update Submit

November 14, 2016

Conditions

Vestibular Schwannoma

Keywords

vestibular rehabilitation

Outcome Measures

Primary Outcomes (3)

  • 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.

    2-3 years

  • 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.

    2-3 years

  • 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.

    2-3 years

Study Arms (1)

gentamicin

EXPERIMENTAL

intratympanic application of gentamicin 0.5 ml

Drug: gentamicin

Interventions

gentamicinDRUG

intratympanic application of gentamicin 2m/80mg - 3x application -0,5 ml

Also known as: gentamycin
gentamicin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • allergy to gentamicin
  • vestibular areflexia on the affected side

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 7603726BACKGROUND

  • 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.

    PMID: 28053986DERIVED

MeSH Terms

Conditions

Neuroma, Acoustic

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., PH.D.

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 15, 2016

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share