Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT05875935
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05875935
Study Brief:
Protocol Section:
NCT05875935