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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT05019404
Eligibility Criteria:
Inclusion Criteria:
1. male or female aged between 18 and 60 years;
2. drug- resistant temporal lobe epilepsy, remaining seizures after two or more tolerated and appropriately chosen antiepileptic drugs;
3. monthly or more seizures during the preceding year prior to trial;
4. the full- scale intelligence quotient (IQ) more than 70, understanding and completing the trial;
5. signing the informed consent;
6. good compliance, at least 12- month follow- up after surgery.
Exclusion Criteria:
1. tumor in temporal lobe;
2. extratemporal epilepsy and temporal plus epilepsy;
3. drug- responsive epilepsy, seizure freedom with current drugs in recent one year;
4. pseudoseizures;
5. seizures arising from bilateral temporal lobes;
6. significant comorbidities including progressive neurological disorders, active psychosis, and drug abuse;
7. a full- scale IQ lower than 70, unable to complete tests;
8. previous epilepsy surgery;
9. poor compliance and inadequate follow- up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05019404
Study Brief:
Protocol Section:
NCT05019404