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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Evaluation of the Impact of Pre-operative Device on the Personal Experience of Brain Awake Surgery: Comparative Study, Randomized

Conditions
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Brain Awake Surgery

Intervention / Treatment
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* Device: preoperative adequate explanations about awake surgery
* Other: no preoperative explanation


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with preoperative device<br>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<br> <br> |
| Active Comparator: Patient with standard procedure<br>patients undergoing brain awake surgery with standard procedure (without adequate explanations) | Other: no preoperative explanation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative experience evaluated postoperatively using a self-administered questionnaire (EVAN LR) | perioperative experience evaluated postoperatively using a self-administered questionnaire (EVAN LR) | 6 days |