TIS for Drug Resistant TLE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TI Stimulation.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study on the Effect of Temporal Interference Stimulation in the Therapy of Drug Resistant Temporal Lobe Epilepsy
Overview
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
- Device TI Stimulation
Temporal interference (TI) targeting hippocampus for 5 days.
Primary outcome measures
- Seizure Frequency Rate Change of One Month [Time frame: One month after treatment]
Secondary outcome measures (2)
- Rate of Seizure Frequency Rate Change of Two Month [Time frame: Two month after treatment]
- Electroencephalogram Change [Time frame: Baseline, 24 hours after treatment, one month after treatment, two months after treatment]
Eligibility criteria
Inclusion criteria
- 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;
- Taking two or more antiepileptic drugs and continuing the same drug regimen for the duration of the trial;
- Could cooperate with the completion of treatment and related examinations;
- Patients and their family members fully understood and voluntarily signed the informed consent.
Exclusion criteria
- 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;
- Patient with pregnant or lactating;
- Patients with contraindications to TI stimulation, fMRI examination or EEG examination, metal implants (pacemakers, metal dentures, metal IUD rings, etc.), or claustrophobia;
- Participating in other clinical trials;
- Patients or their family members withdrew informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07519018 · KY20262074