EpilepsyTITE-SEEGNCT07082101
Temporal Interference for Temporal Lobe Epilepsy Under SEEG
A study testing temporal interference in people with Epilepsy, run by Xijing Hospital at 1 site in China.
Trial summary
This study evaluates the effect of temporal interference (TI) stimulation on biomarkers in patients with temporal lobe epilepsy (TLE) under stereo-electroencephalography (SEEG), and provides theoretical basis for non-invasive TI treatment of temporal lobe epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- temporal interference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to Aug 2026
- 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
- Clinical diagnosis of drug refractory epilepsy and temporal lobe epilepsy;
- Patients undergoing SEEG;
- Able to cooperate the treatment and related inspection;
- Fully understands and signs informed consent.
Who cannot join
- Patients with temporal plus epilepsy;
- In status epilepticus;
- With other severe disease;
- Pregnancy or lactation women;
- Unable to tolerate SEEG or TI;
- At the same time to participate in other clinical trials;
- Withdraw consent procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xijing Hospital
Xi'an, Shaanxi, 710032
Wen Jiang, +86-02984773664, jiangwen@fmmu.edu.cn
About this study
Official title: Evaluating Biomarkers of Temporal Interference for Temporal Lobe Epilepsy Under SEEG
This study evaluates the effect of temporal interference (TI) stimulation on biomarkers in patients with temporal lobe epilepsy (TLE) under stereo-electroencephalography (SEEG), and provides theoretical basis for non-invasive TI treatment of temporal lobe epilepsy.
Read the detailed description
10 patients aged 18-65 years with TLE assessed by semiology, video electroencephalogram and imaging in Epilepsy Center of Xijing Hospital (Xi'an, China) will be recruited. Clinical baseline data such as general information and history of seizures will be collected. The SEEG electrodes were implanted in the Department of neurosurgery of Xijing Hospital and after 24 hours TI will be performed with continuous SEEG monitoring. Finally, the biomarker changes of EEG signals before and after TI treatment were statistically analyzed.
- Conditions
- Epilepsy
- Being tested
- temporal interference
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temporal interferenceOther
In this intervertion, patients with SEEG operation will take temporal interference (TI) stimulation and the deep brain EEG will be monitorated through the entire experiment.
| Study group | Role | What they receive |
|---|---|---|
| Temporal interference | Experimental | Not described Receives: Other: temporal interference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of interictal electrophysiological biomaker changes in epilepsy
Electrophysiological biomarkers changes recorded by SEEG through the experiment.
Measured: 24 hours after TI stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (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.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- 10 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
- NCT07082101
- Sponsor's protocol ID
- KY20252287
- Acronym
- TITE-SEEG
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Biomarkers of Temporal Interference for Temporal Lobe Epilepsy Under SEEG
- ClinicalTrials.gov ID
- NCT07082101
- Acronym / sponsor ID
- TITE-SEEG / KY20252287
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 24 Jul 2025 (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.
This study evaluates the effect of temporal interference (TI) stimulation on biomarkers in patients with temporal lobe epilepsy (TLE) under stereo-electroencephalography (SEEG), and provides theoretical basis for non-invasive TI treatment of temporal lobe epilepsy.
Detailed description
10 patients aged 18-65 years with TLE assessed by semiology, video electroencephalogram and imaging in Epilepsy Center of Xijing Hospital (Xi'an, China) will be recruited. Clinical baseline data such as general information and history of seizures will be collected. The SEEG electrodes were implanted in the Department of neurosurgery of Xijing Hospital and after 24 hours TI will be performed with continuous SEEG monitoring. Finally, the biomarker changes of EEG signals before and after TI treatment were statistically analyzed.
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 | Other: temporal interference |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of drug refractory epilepsy and temporal lobe epilepsy;
- Patients undergoing SEEG;
- Able to cooperate the treatment and related inspection;
- Fully understands and signs informed consent.
Key exclusion criteria (7 listed)
- Patients with temporal plus epilepsy;
- In status epilepticus;
- With other severe disease;
- Pregnancy or lactation women;
- Unable to tolerate SEEG or TI;
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 |
|---|---|---|
| temporal interferenceIn this intervertion, patients with SEEG operation will take temporal interference (TI) stimulation and the deep brain EEG will be monitorated through the entire experiment. | Other | Temporal interference |
Primary outcome
Number of interictal electrophysiological biomaker changes in epilepsy
Time frame: 24 hours after TI stimulation
Electrophysiological biomarkers changes recorded by SEEG through the experiment.
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 24 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing temporal interference in people with Epilepsy, run by Xijing Hospital at 1 site in China.
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 4 inclusion and 7 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 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Wen Jiang (+86-02984773664, jiangwen@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of interictal electrophysiological biomaker changes in epilepsy (time frame: 24 hours after TI stimulation). 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 24 Jul 2025.