EpilepsyTITE-EffectNCT07519018
TIS for Drug Resistant TLE
A study testing TI Stimulation in people with Epilepsy, run by Xijing Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- TI Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Study on the Effect of Temporal Interference Stimulation in the Therapy of Drug Resistant Temporal Lobe Epilepsy
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.
- Conditions
- Epilepsy
- Being tested
- TI Stimulation
- Keywords
- TIS, TLE
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TI StimulationDevice
Temporal interference (TI) targeting hippocampus for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Temporal interference | Experimental | Not described Receives: Device: TI Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Frequency Rate Change of One Month
Measured: One month after treatment
Secondary outcomes (2)
Rate of Seizure Frequency Rate Change of Two Month
Measured: Two month after treatment
Electroencephalogram Change
Measured: Baseline, 24 hours after treatment, one month after treatment, two months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519018
- Sponsor's protocol ID
- KY20262074
- Acronym
- TITE-Effect
- Status last verified
- Mar 2026
- First submitted
- 1 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Temporal Interference Stimulation in the Therapy of Drug Resistant Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT07519018
- Acronym / sponsor ID
- TITE-Effect / KY20262074
- Conditions
- Epilepsy
- Keywords
- TIS, TLE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporal interference | Experimental | Device: TI Stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TI StimulationTemporal interference (TI) targeting hippocampus for 5 days. | Device | Temporal interference |
Primary outcome
Seizure Frequency Rate Change of One Month
Time frame: One month after treatment
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TI Stimulation in people with Epilepsy, run by Xijing Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure Frequency Rate Change of One Month (time frame: One month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.