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Assessment of Awake Surgery With Electrocorticographic Recordings in the Management of Gliomas and Correlation With Imaging Data (ECoG)

R

Ramsay Générale de Santé

Status

Terminated

Conditions

Glioma
Electrocorticography
Karnofski Index

Treatments

Procedure: ECoG : electrocorticography

Study type

Interventional

Funder types

Other

Identifiers

NCT05875935
2019-A02005-52

Details and patient eligibility

About

This study proposes to analyze data from intraoperative ECoG recordings acquired during wakefulness interventions in order to identify the connection networks involved in cognitive functions. This study also proposes to correlate the ECoG data with the imaging data and to analyze the disturbances of the electrophysiological signals induced by the cortical and subcortical brain lesions: this will make it possible to establish a more detailed mapping of the tumor areas and to compare disturbances recorded to those recorded in healthy areas. Thus, this approach should make it possible to improve the quality of excision of glial lesions located in eloquent areas, while reducing the risk of neurological sequelae and thus improve the survival and quality of life of patients.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Man or woman over 18 years-old
  • Subject with a non-recurrent glial lesion requiring surgery in vigilant condition;
  • Brain lesion located in the functional zone;
  • Major not protected within the meaning of the law;
  • Subject affiliated to a Health Insurance scheme;
  • No medical contraindication to performing an MRI (pacemaker);
  • No medical contraindication to surgery and anesthesia;
  • Karnofski index> 70;
  • Subject having signed an informed consent.

Exclusion criteria

  • Minor subject, pregnant or breastfeeding woman;
  • Major subject subject under measure of legal protection, guardianship or deprived of liberty by judicial or administrative decision;
  • Subject hospitalized without consent;
  • Subject treated with antipsychotics (neuroleptic or lithium);
  • Subject who has already been treated for his glial lesion by surgery and / or radiotherapy;
  • Subject refusing to sign an informed consent.
  • Subject wishing to discontinue participation in the study before completion;
  • Subject for which the surgical intervention and / or the ECoG recording could not be carried out after admission to the operating room (whatever the reason).

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1 participants in 1 patient group

Subject with a non-recurrent glial lesion requiring surgery in vigilance
Experimental group
Treatment:
Procedure: ECoG : electrocorticography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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