Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery

Vestibular Schwannoma Clinical Trial

Official title:

Assessment of Visual Sensitivity, Psychiatric Profile and Quality of Life Following Vestibular Schwannoma Surgery in Patients Prehabituated by Chemical Vestibular Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638310
• Other study ID #: 13943 FN Motol
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: June 1, 2018

Study information

• Verified date: August 2018
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess effect of psychiatric profile on visual sensitivity and overall health status in patients who underwent surgery for vestibular schwannoma and were prehabituated by chemical vestibular ablation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• T3, T4 vestibular schwannoma

• recorded growth of a tumour

• hearing loss greater than 50% in PTA

Exclusion Criteria:

• T1 vestibular schwannomas

• no growth progression

• normal hearing

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Diseases
• Vestibular Function Disorder
• Vestibular Schwannoma

Intervention

Procedure:
• intratympanic application of gentamicin
under local anesthesia is gentamicin instilled through tympanic membrane to tympanic cavity
• microsurgical removal of vestibular schwannoma
surgery under general anesthesia

Locations

Country	Name	City	State
Czechia	Charles University	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Cada Z, Balatková Z, Chovanec M, Cakrt O, Hrubá S, Jerábek J, Zverina E, Profant O, Fík Z, Komarc M, Betka J, Kluh J, Cerný 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of optokinetic nystagmus measurement	During electronystagmography gain of optokinetic nystagmus is measured before and after the intervention	change of the gain of optokinetic nystagmus among 3 time points is measured: before intervention, 1 week after intervention, 3 months after intervention