Skip to content

An exploratory study of transcranial alternating current stimulation in the treatment of epileptic encephalopathy in children

An exploratory study of transcranial alternating current stimulation in the treatment of epileptic encephalopathy in children

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083660
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

epileptic encephalopathy

Interventions

test group:High-Definition Transcranial Electrical Stimulation

Sponsors

Shenzhen Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 3 Years

Inclusion criteria

Inclusion criteria: (1) between 1 and 3 years of age, (2) meeting the criteria for EE diagnosis, (3) complete clinical data, (4) insufficient response to the combination of two or more antiepileptic drugs, (5) seizure frequency= 1 time/week, (6) no change in anticonvulsant medication during tACS intervention. Diagnostic criteria for epileptic encephalopathy: (1) Two clinical episodes (at least 24 hours apart) of unprovoked seizures; (2) early age of onset; (3) Obvious abnormality of electroencephalography; (4) progressive neuropsychiatric dysfunction or degeneration; (5) or meet the following diagnostic criteria for epilepsy syndromes: 1)IS: Serial seizures, EEG between episodes shows typical high arrhythmia or variant high arrhythmia, often accompanied by psychomotor retardation or regression, and normal development before the onset of the disease. 2) OS: tonic and spasmodic seizures in early infancy, EEG burst inhibition pattern, severe psychomotor disorders. 3) DS: onset within 1 year of age, the first episode is mostly febrile seizures; within 1 year of age, the main manifestations are fever-induced generalized or hemiclonic convulsions of a long duration, after 1 year of age, various forms of athermic convulsions gradually appear, and the seizures are often heat-sensitive; early development is normal, after 1 year of age, intellectual and motor development is delayed or regressed, ataxia and pyramidal signs may appear; EEG is often not abnormal before 1 year of age, and after 1 year of age, generalized spinous slow waves, multispinous slow waves or focal, Multifocal epileptiform discharge. 4) LGS: multiple types of seizures, generalized slow (1.5-2.5Hz) spike-slow complex wave on EEG, mental retardation. 5) EME: segmental, migratory myoclonus from the first day to the first few weeks after birth, EEG burst inhibition pattern, psychomotor retardation. 6) ECSWS: electroencephalogram (EEG) slow-wave electro-continuous during sleep, various types of seizures, neuropsychological and motor behavior disorders.

Exclusion criteria

Exclusion criteria: (1) Symptomatic epilepsy caused by tumors, trauma, infection, and focal cortical dysplasia was excluded;(2) Anticonvulsant drug therapy was effective;(3) Seizure frequency<1 seizure/week;(4) Changes in anticonvulsant medication during tACS intervention; (5) Refusal of parents to participate in clinical trials;

Design outcomes

Primary

MeasureTime frame
Seizure frequency;Mental development;

Secondary

MeasureTime frame
Changes in the number of spikes and EEG background in patients with interictal EEG;

Countries

China

Contacts

Public ContactDezhi Cao

Shenzhen Children's Hospital

1269888128@qq.com+86 189 3869 1158

Outcome results

None listed

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