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Trial record 5 of 52 for:    "Acoustic neuroma"

Vestibular Schwannoma and Psychological Factors

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ClinicalTrials.gov Identifier: NCT01743248
Recruitment Status : Unknown
Verified December 2012 by Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Sponsor:
Collaborator:
University of Lorraine
Information provided by (Responsible Party):
Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France

Brief Summary:

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 or disease
Vestibular Schwannoma

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.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Influence of Psychological Factors on Balance Control Compensation After Vestibular Schwannoma Surgery
Study Start Date : August 2012
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2016





Primary Outcome Measures :
  1. psycholgical factors measures [ Time Frame: one year ]

    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)


  2. balance control performance [ Time Frame: one year ]
    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

  3. vestibular performance [ Time Frame: one year ]
    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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

Keywords provided by Cecile PARIETTI-WINKLER, Central Hospital, Nancy, France:
vestibular schwannoma
balance
psychological factors

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