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

NCT ID: NCT02310516

Last Updated: 2015-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30

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.

Conditions

Brain Awake Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

preoperative adequate explanations about awake surgery

Intervention Type: DEVICE

Patient with standard procedure

patients undergoing brain awake surgery with standard procedure (without adequate explanations)

Group Type: ACTIVE_COMPARATOR

no preoperative explanation

Intervention Type: OTHER

Interventions

preoperative adequate explanations about awake surgery

Intervention Type: DEVICE

no preoperative explanation

Intervention Type: OTHER

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urielle DESALBRES

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Mathieu CECCALDI

Role: CONTACT

mathieu.ceccaldi@ap-hm.fr

Facility Contacts

Mathieu CECCALDI

Role: primary

mathieu.ceccaldi@ap-hm.fr

Other Identifiers

RC12_3677

Identifier Type: REGISTRY

Identifier Source: secondary_id

2013-39

Identifier Type: -

Identifier Source: org_study_id