Refractory Epilepsy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for DRE as defined by both traditional Chinese medicine and Western medicine; 2. Age between 18 and 80 years, with no restriction on gender; 3. The dosage of antiepileptic drugs taken in accordance with standard guidelines remains unchanged throughout the study period; 4. Right-handedness; 5. The participant is fully informed and provides voluntary written consent.
Exclusion criteria
Exclusion criteria: 1. Status epilepticus occurred within the past year; 2. Progressive brain disease with severe cranial anatomical asymmetry or clear lesions observed on MRI scans; 3. Severe heart, liver, or kidney diseases, or severe neuropsychiatric diseases; 4. Use of psychotropic drugs, history of alcohol abuse, or drug misuse; 5. Pregnant or planning to become pregnant; 6. Implanted with a cardiac pacemaker, vagus nerve stimulator, or metal devices; 7. Allergic constitution, prone to infections or bleeding, or patients with peptic ulcers; 8. Local skin damage in the ear area (e.g., epidermal rupture, scabbing, or scars); 9. Unable to understand or cooperate with the examination, or having claustrophobia or other contraindications for MRI; Note: Any individual meeting one or more of the above nine criteria shall be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure frequency: 50% response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electroencephalogram;Functional magnetic resonance imaging (fMRI), Diffusion Tensor Imaging (DTI);Quality Of Life In Epilepsy, QOLIE-31;Sleep Diary;Traditional Chinese Medicine Constitution Scale; | — |
Countries
China
Contacts
Beijing University of Chinese Medicine Dongzhimen Hospital