Refractory epilepsy
Conditions
Interventions
treatment group:transcranial plasma stimulation
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age 6-60 years old; 2.When 2 first-line antiepileptic drugs alone or in combination reach the therapeutic dose, there are still 2 (or more) seizures per month; 3.Confirmed focal seizures, secondary or non-secondary bilateral tonic-clonic seizures (according to ILAE 2017 seizure classification); 4.History of epilepsy greater than 1 year; 5.There was no change in daily antiepileptic medication in the 1 month prior to the baseline period, and participants agreed to keep their antiepileptic medication unchanged throughout the study; 6.The subjects had good compliance and were able to meet the requirements of post-treatment follow-up; 7.Sign informed consent;
Exclusion criteria
Exclusion criteria: 1.False epileptic seizure; 2.Progressive brain disease or serious systemic disease other than epilepsy; 3.Severe depression, anxiety, compulsion or other mental illness or drug or poison abuse; 4.lactation or pregnancy; 5.Doctors with sufficient experience will make a comprehensive determination of those who are not suitable for treatment after synthesizing the relevant conditions of the patient;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage reduction in seizure frequency from baseline by week4 post-treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| (Treatment Emergent Symptom Scale, TESS)?(Adverse Event Scale,AES)?;The percentage reduction in seizure frequency from baseline by week 8 and week 12 post-treatment.;Changes in peripheral blood inflammatory cytokine levels from baseline to immediately after treatment and to the end of the 12th week after treatment.;Change in quantity of interictal epileptiform discharges (spikes, sharp waves) post-treatment versus baseline.;Changes in TSPO-PET and FDG-PET signals in the regions of interest at immediate post-treatment compared to baseline.; | — |
Countries
China
Contacts
Public ContactYuing Wang
Xuanwu Hospital Capital Medical University
Outcome results
None listed