Vestibular Schwannoma and Psychological Factors

NCT ID: NCT01743248

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-08-31

Brief Summary

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The surgery of a vestibular schwannoma induces balance disorders which have a an impact on the patient's daily life and disrupt their quality of life.

But the balance disorders don't seem to be the only ones factors that impaired the patient's quality of life. It has been alrealdy shown that emotional and psychological factors are also related to patient's quality of life.

This study evaluates the relationship between the balance control compensation and these factors (i.e. emotional and psychological) in the vestibular schwannoma resection process.

Detailed Description

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The research protocol is based on 5 evaluation: 3 days before surgery, 8 days, 30 days, 90 days and 360 days after surgery including posturographic tests, videonystagmography and psychological questionnaires at each evaluation.

Conditions

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Vestibular Schwannoma

Keywords

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vestibular schwannoma balance psychological factors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* patients with unilateral vestibular schwannoma (stage I to IV according to the Koos classification) with an indication for surgery.
* age between 18 and 75 years
* patients with written informed consent
* patients with Social Security affiliation

Exclusion Criteria

* patients with psychiatrics pathologies
* ear pathology different from vestibular schwannoma (cholesteatoma of the middle ear, tympanic membrane perforation)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lorraine

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Cecile PARIETTI-WINKLER

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cécile PARIETTI-WINKLER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

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Centre Hospitalier Universitaire de Nancy

Nancy, Nancy, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cécile Parietti-Winkler, MD, PhD

Role: CONTACT

Phone: +33 3 83 85 20 32

Email: [email protected]

Gérome GAUCHARD, Phd

Role: CONTACT

Phone: +33 3 83 68 39 26

Email: [email protected]

Facility Contacts

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Cécile Parietti-Winkler, MD, PhD

Role: primary

Gérome Gauchard, PhD

Role: backup

Other Identifiers

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2012-A00522-41

Identifier Type: -

Identifier Source: org_study_id