TIS for Drug Resistant TLE
ConditionEpilepsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXijing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 to 65 years old;
According to the 2010 International League Against Epilepsy (ILAE) diagnostic criteria for drug-resistant epilepsy;
Temporal lobe epilepsy assessed by semiology, video electroencephalogram, and imaging;
The duration of epilepsy was ≥2 years, and the average seizure frequency was ≥2 times per month in the 3 months before enrollment;
Disqualifiers
The anti-seizure medication therapy was adjusted during the treatment and follow-up period;
Patient in status epilepticus;
Patient with other systemic diseases leading to nervous system involvement and seizures;
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;
Trial design
Design model
Single group
Treatments tested in this trial
TI Stimulation
DeviceTemporal interference (TI) targeting hippocampus for 5 days.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Temporal interferenceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Seizure Frequency Rate Change of One Month
Time frame
One month after treatmentSecondary outcomes
1
Rate of Seizure Frequency Rate Change of Two Month
Time frame
Two month after treatment2
Electroencephalogram Change
Time frame
Baseline, 24 hours after treatment, one month after treatment, two months after treatmentOther outcomes
1
fMRI Change
Time frame
Baseline, the moment after the first TI stimulationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: