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Relationship between the time point of reducing/stopping antiepileptic drugs after epilepsy surgery in children and the prognosis of epilepsy

Relationship between the time point of reducing/stopping antiepileptic drugs after epilepsy surgery in children and the prognosis of epilepsy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092043
Enrollment
Unknown
Registered
2024-11-07
Start date
2022-08-01
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-refractory epilepsy

Interventions

Group 1 (early reduction group):Antiepileptic drugs were reduced after operation (no seizures occurred at 3, 6 and 12 months after operation, and one antiepileptic drug was stopped every three months)
Group 2(late early reduction group):Antiepileptic drugs were reduced after operation (there was no seizure at 12, 18 and 24 months after operation, and one antiepileptic drug was stopped every three m

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) The operative age is =2 kinds of ASM; before operation; (3) There was no seizure within two weeks after epilepsy operation; (4) The lesion is located on one side, and MRI after operation shows that the lesion structure is completely removed/severed or the epileptogenic zone is completely removed/Isolation; (5) 24-hour scalp EEG after 7-14 days meets the following criteria: no persistent, disconnected from the diseased side. Except for sexual surgery) consistent and rhythmic epileptiform discharge or slow wave (local rhythmic epileptiform discharge or Slow wave, local persistent epileptiform discharge or slow wave). Note: 1) Complete resection/amputation of diseased structures: According to postoperative MRI of the head, abnormal areas of structures were completely excised or amputated; 2) Complete excision/disconnection of epileptogenic focus: The intraoperative electrocorticogram after excision did not show continuous and rhythmic epileptiform discharge consistent with the lesion.

Exclusion criteria

Exclusion criteria: (1) The patient is over 12 years old at the time of operation; (2) Oral administration of <=1 ASM; before operation; (3) Epilepsy occurred within two weeks after operation; (4) Brain MRI showed bilateral lesions; (5) The lesion is located in the functional area, and the excision/disconnection of the structural lesion or epileptogenic area is incomplete due to functional protection; (6) Postoperative MRI showed that the lesion was not completely resected/severed; (7) Intraoperative EEG monitoring showed that the epileptogenic zone was not completely excised/severed; (8) There were persistent, rhythmic epileptiform discharges or slow waves (local rhythmic epileptiform discharges or slow waves, local persistent epileptiform discharges or slow waves) in scalp EEG 24 hours after operation 7-14 days.

Design outcomes

Primary

MeasureTime frame
Comparison of seizure-free rate between the two groups after one-year follow-up;

Secondary

MeasureTime frame
Changes of developmental quotient/IQ;

Countries

China

Contacts

Public ContactTaoyun Ji

Peking University First Hospital

jitaoyun@163.com+86 138 1149 2088

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026