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Prospective Evaluation of the Impact of Pre-operative Device on the Personal Experience of Brain Awake Surgery (EVECHE)

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ClinicalTrials.gov Identifier: NCT02310516
Recruitment Status : Unknown
Verified August 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : December 8, 2014
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

The brain awake surgery has recently boomed in neurosurgical oncology but also in epilepsy surgery. The goal of awake surgery is to allow a more precise localization of sensorimotor functions, languages and cognitive to better respect them. Indeed, the interindividual anatomo-functional variations, the lack of specificity of functional explorations radiological magnetic or nuclear, as well as the reorganization of the areas involved in these functions (mechanisms of brain plasticity) in epileptic patients or patients with cerebral tumor do not allow to identify them in preoperatively. Brain awake surgery allows an analysis and a precise real-time identification of areas and networks involved in these functions through a direct electrical stimulation (inhibitory or activatory). Thus, this surgical technique has become a gold standard in surgery of brain lesions located in functional areas.

However, although the brain awake surgery has been practiced since many years, the confidentiality of these informations until recent years explains probably that very little data to be available on the personal experience of this procedure by patients. Studies that have analyzed the perception of the patient or the satisfaction of the patient after surgery in awake conditions were retrospective and included few patients. The investigators experience of lived of this surgery that the investigators have developed in the investigators team since over four years is that on the whole awake surgery is well tolerated if adequate explanations are provided preoperatively and if a minimum of preoperative precautions are observed.

Thus, the investigators have decided to develop a preoperative device that could improve personal experience and well-being of patients undergoing this surgical approach.


Condition or disease Intervention/treatment Phase
Brain Awake Surgery Device: preoperative adequate explanations about awake surgery Other: no preoperative explanation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Prospective Evaluation of the Impact of Pre-operative Device on the Personal Experience of Brain Awake Surgery: Comparative Study, Randomized
Study Start Date : September 2014
Estimated Primary Completion Date : March 2017

Arm Intervention/treatment
Experimental: Patient with preoperative device
patients undergoing brain awake surgery with adequate explanations which are provided preoperatively. Preoperative device corresponds to a pre/ perioperative coaching involving the provision of a comprehensive information support on the awake surgery (short video and information brochure) and an interview with an operating room nurse
Device: preoperative adequate explanations about awake surgery
Active Comparator: Patient with standard procedure
patients undergoing brain awake surgery with standard procedure (without adequate explanations)
Other: no preoperative explanation



Primary Outcome Measures :
  1. Perioperative experience evaluated postoperatively using a self-administered questionnaire (EVAN LR) [ Time Frame: 6 days ]
    perioperative experience evaluated postoperatively using a self-administered questionnaire (EVAN LR)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject with a low grade glioma targeted for intervention in the awake brain surgery;
  • Subject able to complete a self-administered questionnaire;
  • Subjects who have signed a written informed consent and agreeing to abide by the instructions of the protocol

Exclusion Criteria:

  • Minor, pregnant or lactating women, not affiliated to the social security system;
  • Subject severe respiratory failure;
  • Subjects treated with antipsychotic (neuroleptic or lithium);
  • Subjects with cognitive impairment degenerative previously documented (Alzheimer, dementia other);
  • subject active addict;
  • Subject with personal psychiatric history;

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): NCT02310516


Contacts
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Contact: Mathieu CECCALDI mathieu.ceccaldi@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille cedex 5, France, 13354
Contact: Mathieu CECCALDI       mathieu.ceccaldi@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02310516    
Other Study ID Numbers: 2013-39
RC12_3677 ( Registry Identifier: APHM )
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: August 2015