NCT02869698

Brief Summary

This prospective research aims to develop the use of Spectral Imaging in addition Dynamics of cortical electrical stimulation to identify major anatomical and functional networks in epileptic patients candidates for surgery and explored by stereoencephalography, to minimize risk of post-surgical cognitive deficits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

7.9 years

First QC Date

August 4, 2016

Last Update Submit

October 25, 2017

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Functional brain mapping procedure using the EEG signal intracranial to minimize the risk of cognitive deficits associated with resection of the epileptogenic zone.

    3 weeks

Study Arms (1)

Evaluation of cognitive functions by Spectral Dynamic Imaging

EXPERIMENTAL

Evaluation of cognitive functions by SDI will be conducted during the exploration SEEG (which usually lasts from 1 to 3 weeks), and started a few days after implantation of intracranial electrodes

Procedure: Spectral Dynamic ImagingDevice: Hybride electrodeDevice: Macro electrode

Interventions

Spectral Dynamic ImagingPROCEDURE
Evaluation of cognitive functions by Spectral Dynamic Imaging
Hybride electrodeDEVICE
Also known as: AdTech Medical Instrument Corporation
Evaluation of cognitive functions by Spectral Dynamic Imaging
Macro electrodeDEVICE
Also known as: DIXI Microtechniques
Evaluation of cognitive functions by Spectral Dynamic Imaging

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Drug-resistant partial epilepsy justifying a SEEG exploration
  • Intellectual capacities compatible with the award of cognitive tasks

You may not qualify if:

  • Pregnant or lactating women
  • Patient deprived of liberty by a judicial or administrative
  • Major patient subject to a measure of legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Grenoble

Grenoble, France

Location

University Hospital Lyon

Lyon, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Philippe KAHANE

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 17, 2016

Study Start

June 1, 2009

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)