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Non-randomized controlled clinical study of vagal nerve stimulation in the treatment of children with refractory epilepsy spasms

Non-randomized controlled clinical study of vagal nerve stimulation in the treatment of children with refractory epilepsy spasms

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017881
Enrollment
Unknown
Registered
2018-08-20
Start date
2018-08-28
Completion date
Unknown
Last updated
2018-08-27

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

Conditions

refractory epilepsy spasms

Interventions

Case series:vagal nerve stimulation

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 6 Years

Inclusion criteria

Inclusion criteria: 1) <6 years old children with epilepsy; 2) Conforming to the definition of drug refractory epilepsy; 3) Spasticity or spasticity as the main type of seizure; 4) There were no definite lesions in cranial imaging, multiple lesions without definite location of epileptogenic foci, or epileptogenic foci located in functional areas; 5) In addition to epilepsy, the body is in good health and can tolerate vagus nerve stimulation; 6) Parents fully understand the treatment program, and signed informed consent, good compliance, can cooperate with the completion of postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1) Surgical treatment can be performed; 2) Complicated with progressive nervous system diseases, mental disorders, tumors, arrhythmias, heart failure, asthma, peptic ulcer, insulin-dependent diabetes mellitus or poor general condition; 3) Unilateral or bilateral vagus nerves themselves are damaged or damaged; 4) Patients who are currently undergoing clinical trials of other drugs or devices; 5) Incomplete preoperative examination.

Design outcomes

Primary

MeasureTime frame
Seizure frequency;

Secondary

MeasureTime frame
VEEG;GDS-C;PEDI;SAS;SDS;

Countries

China

Contacts

Public ContactFang Fang

Beijing Children's Hospital, Capital Medical University

13910150389@163.com+86 13370115051

Outcome results

None listed

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