Vestibular Schwannoma and Psychological Factors

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Central Hospital, Nancy, France
Sponsor:
Collaborator:
University of Lorraine
Information provided by (Responsible Party):
Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01743248
First received: September 28, 2012
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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.


Condition
Vestibular Schwannoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Influence of Psychological Factors on Balance Control Compensation After Vestibular Schwannoma Surgery

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • psycholgical factors measures [ Time Frame: one year ] [ Designated as safety issue: No ]

    The same evaluation protocole will be performed 5 times (3 days before surgery, 8 days, 30 days, 90 days and one year after surgery), with this measures:

    -score of psychological questionnaires:Revised NEO Personality Inventory (NEO PI-R), Bref Cope (coping questionnaire), Revised Illness Perception Questionnaire (IPQ-R),World Health Organisation quality of life(WHOQOL-Bref) and Hospital Anxiety and Depression Scale (HADS)


  • balance control performance [ Time Frame: one year ] [ Designated as safety issue: No ]
    The same evaluation protocole will be performed 5 times (3 days before surgery, 8 days, 30 days, 90 days and one year after surgery), with the measures of the score of balance performance with sensory organisation test

  • vestibular performance [ Time Frame: one year ] [ Designated as safety issue: No ]
    The same evaluation protocole will be performed 5 times (3 days before surgery, 8 days, 30 days, 90 days and one year after surgery), with the measures of the score of vestibular performance with videonystagmography


Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with vestibular schwanomma with an indication for surgery.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743248

Contacts
Contact: Cécile Parietti-Winkler, MD, PhD +33 3 83 85 20 32 c.parietti@chu-nancy.fr
Contact: Gérome GAUCHARD, Phd +33 3 83 68 39 26 gerome.gauchard@inserm.fr

Locations
France
Centre Hospitalier Universitaire de Nancy Recruiting
Nancy, France, 54035
Contact: Cécile Parietti-Winkler, MD, PhD    +33 3 83 85 20 32    c.parietti@chu-nancy.fr   
Contact: Gérome Gauchard, PhD    +33 3 83 68 39 26    gerome.gauchard@inserm.fr   
Sub-Investigator: Gerome GAUCHARD, PhD         
Sub-Investigator: Philippe PERRIN, MD, PhD         
Sub-Investigator: Elisabeth SPITZ, PhD         
Sub-Investigator: Laurence RIBEYRE         
Sub-Investigator: Alexis LION, PhD         
Sponsors and Collaborators
Central Hospital, Nancy, France
University of Lorraine
Investigators
Principal Investigator: Cécile PARIETTI-WINKLER, MD, PhD Central Hospital, Nancy, France
  More Information

No publications provided

Responsible Party: Cecile PARIETTI-WINKLER, Principal Investigator, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01743248     History of Changes
Other Study ID Numbers: 2012-A00522-41
Study First Received: September 28, 2012
Last Updated: December 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Central Hospital, Nancy, France:
vestibular schwannoma
balance
psychological factors

Additional relevant MeSH terms:
Neurilemmoma
Neuroma, Acoustic
Cranial Nerve Diseases
Cranial Nerve Neoplasms
Ear Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nerve Sheath Neoplasms
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors
Neuroendocrine Tumors
Neuroma
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Peripheral Nervous System Neoplasms
Retrocochlear Diseases
Vestibulocochlear Nerve Diseases

ClinicalTrials.gov processed this record on October 23, 2014