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

March 24, 2020 updated by: University Hospital, Grenoble
New method for speech area cartography in patient individual cortical anatomy in view of improving functional area limit preservation during surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BRAINSPEAK
Electrocorticographical (ECoG) and intracortical electrodes
Device: ECoG and intracortical electrodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
electrophysiological recording
Time Frame: 2 hours
Electrophysiological recording of brain Speech Area, using Cortical Electrode Matrices, in order to improve functional area limit preservation during surgery
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • BRAINSPEAK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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