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:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT04417933
Eligibility Criteria:
Inclusion Criteria:
* Patients with pathological diagnosis of glioblastoma at first surgery (WHO Grade IV, supratentorial location);
* Age between 18 and 65 years, male or female;
* Previously completed radiotherapy and at least two cycles of chemotherapy;
* With imaging or pathological evidence of tumor recurrence;
* Karnofsky performance score (KPS) score ≥ 70 before intervention;
* With a life expectancy more than 3 months;
* Adopted effective contraceptive measures at child-bearing age;
* Provided written informed consent.
Exclusion Criteria:
* Patients unwilling to use the equipment ≥ 18h per day;
* With poor compliance or live too far from the research center, who cannot keep regular follow-up or adjust the electrode position of the treatment equipment, and who refuse to receive follow-up to terminal survival;
* With poor healing of scalp wound, poor scalp condition, large skull defect or other cases where electrodes are not suitable for wearing;
* Within 3 months from radiotherapy;
* Within 4 weeks from the last cycle of chemotherapy;
* Within 4 weeks from surgery for recurrence;
* Participated in other clinical trials.
* Pregnant;
* Epilepsy symptoms not effectively controlled;
* Blood and biochemical indicators in the following range: A. Liver function impairment: AST or ALT \> 3 times the upper limit of normal; B. Total bilirubin\> upper limit of normal value; C. Renal impairment: serum creatinine\>1.7mg /dL (\>150 mol/L); D. Coagulopathy: PT or APTT \>1.5 times normal; E. Platelets counts \< 100x10\^9/L; F. Absolute neutrophils count \< 1x10\^9/L; G. Hemoglobin \< 100g/L;
* With severe infectious diseases, such as acute severe infection and HIV positive;
* Other conditions, such as an implanted cardiac pacemaker or deep brain stimulator, severe intracranial edema, increased intracranial pressure resulting in midline shift\>5mm, clinically significant papilledema, or reduced level of consciousness, allergy to conductive coupling agent, gel, and other serious life-threatening diseases.
* Other circumstances considered inappropriate to participate in the research by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04417933
Study Brief:
Protocol Section:
NCT04417933