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
About this trial
This is an interventional supportive care trial for Vestibular Schwannoma focused on measuring vestibular rehabilitation
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
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
NCT ID
NCT02963896
First Posted
November 1, 2016
Last Updated
November 14, 2016
Sponsor
University Hospital, Motol
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
Learn more about this trial
Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma
We'll reach out to this number within 24 hrs