NCT02310516

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	preoperative adequate explanations about awake surgery
OTHER	no preoperative explanation

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-03-01
• First posted: 2014-12-08
• Last updated: 2015-11-17

Locations

1 site across 1 country: France