Pre and Per-operative Electrophysiological Cartography of Speech Area With Cortical Electrode Matrices

Not Applicable

• Conditions: Tumoral or Epileptical Cortectomy
• Interventions: Device: ECoG and intracortical electrodes

• Registration Number: NCT02783391
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

New method for speech area cartography in patient individual cortical anatomy in view of improving functional area limit preservation during surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-26
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25
• Primary Completion: 2021-06
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients needing cortectomy
• Male or female aged over 18 years
• Registered in the French social security scheme
• Signed informed consent

Exclusion Criteria

•All categories of protected persons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BRAINSPEAK	ECoG and intracortical electrodes	Electrocorticographical (ECoG) and intracortical electrodes

Primary Outcome Measures

Name	Time	Method
electrophysiological recording	2 hours	Electrophysiological recording of brain Speech Area, using Cortical Electrode Matrices, in order to improve functional area limit preservation during surgery

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 Grenoble, France