Epilepsy
Conditions
Keywords
TIS, TLE
Brief summary
Temporal interference (TI) stimulation is a new neuromodulation method. Compared with traditional neuromodulation therapy, TI has deep targeting and focusing, and it has been confirmed to modulate sleep, cognition, and movement disorders. Recent study shown that TI stimulation targeting the hippocampus could significantly reduce epileptiform discharges, but its efficacy on seizures was still unclear. Therefore, the aim of this study is to observe the therapeutic effect of TI stimulation targeting the hippocampus in patients with refractory temporal lobe epilepsy (TLE) for 5 days, and to provide support for clinical trials of non-invasive treatment of refractory TLE.
Interventions
DEVICETI Stimulation
Temporal interference (TI) targeting hippocampus for 5 days.
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 65 years old; 2. According to the 2010 International League Against Epilepsy (ILAE) diagnostic criteria for drug-resistant epilepsy; 3. Temporal lobe epilepsy assessed by semiology, video electroencephalogram, and imaging; 4. The duration of epilepsy was ≥2 years, and the average seizure frequency was ≥2 times per month in the 3 months before enrollment; 5. Taking two or more antiepileptic drugs and continuing the same drug regimen for the duration of the trial; 6. Could cooperate with the completion of treatment and related examinations; 7. Patients and their family members fully understood and voluntarily signed the informed consent.
Exclusion criteria
1. The anti-seizure medication therapy was adjusted during the treatment and follow-up period; 2. Patient in status epilepticus; 3. Patient with other systemic diseases leading to nervous system involvement and seizures; 4. Patients with severe infection, cerebrovascular disease, malignant tumor and other diseases, accompanied by severe dysfunction of heart, liver, kidney and other organs, or accompanied by severe mental or cognitive impairment, or intractable hyperglycemia, or long-term use of corticosteroids; 5. Patient with pregnant or lactating; 6. Patients with contraindications to TI stimulation, fMRI examination or EEG examination, metal implants (pacemakers, metal dentures, metal IUD rings, etc.), or claustrophobia; 7. Participating in other clinical trials; 8. Patients or their family members withdrew informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure Frequency Rate Change of One Month | One month after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Seizure Frequency Rate Change of Two Month | Two month after treatment |
| Electroencephalogram Change | Baseline, 24 hours after treatment, one month after treatment, two months after treatment |
Outcome results
None listed