EpilepsyNCT07790224
Multi-Parameter Temporal Interference Stimulation in Patients With Epilepsy Undergoing SEEG Monitoring
A study testing Temporal Interference Stimulation in people with Epilepsy, run by Beijing Sanbo Brain Hospital at 1 site in China.
Trial summary
This prospective exploratory interventional study aims to investigate the neurophysiological effects and safety of multi-parameter temporal interference (TI) stimulation in patients undergoing stereoelectroencephalography (SEEG) monitoring. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Temporal Interference Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2026to 31 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years, inclusive, with no restriction on sex.
- Has undergone stereoelectroencephalography (SEEG) electrode implantation, with electrode contacts covering the target deep brain region(s), such as the thalamus, hippocampus, amygdala, or cingulate cortex.
- Is in the postoperative SEEG monitoring period, is clinically stable, and is able to comply with the study procedures.
- The participant or the participant's legally authorized representative is able to fully understand the purpose and procedures of the study and voluntarily provides written informed consent.
Who cannot join
- Contraindications to magnetic resonance imaging (MRI), such as incompatible metallic implants or a cardiac pacemaker.
- Psychiatric disorders or severe cognitive impairment.
- Structural brain abnormalities, such as cerebral infarction, hydrocephalus, or severe thalamic atrophy.
- Other severe neurological disorders that may interfere with participation in the study.
- Medical or psychiatric contraindications, including recent myocardial infarction, cardiac arrhythmia, stroke, autonomic dysfunction, endocrine disorders, uncontrolled or difficult-to-control hypertension or hypotension, deep brain stimulation for other reasons, degenerative central nervous system disorders, or severe electrolyte disturbances.
- Pregnancy or breastfeeding.
- Participation in another drug or medical device clinical study within 3 months before screening.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
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
Beijing Sanbo Brain Hospital
Beijing, Beijing Municipality, 100018
Jian Zhou, +86（10）85130669, zhoujian5151@163.com
About this study
Official title: A Stereoelectroencephalography-Based Study of Brain Functional Modulation by Multi-Parameter Temporal Interference Stimulation in Patients With Epilepsy
This prospective exploratory interventional study aims to investigate the neurophysiological effects and safety of multi-parameter temporal interference (TI) stimulation in patients undergoing stereoelectroencephalography (SEEG) monitoring. Participants who have already undergone SEEG electrode implantation for clinical indications will receive non-invasive TI stimulation targeting selected deep brain regions according to their individual electrode coverage and neuroimaging data. Multiple stimulation frequencies will be tested while intracranial SEEG signals are recorded before, during, and after stimulation. The study will characterize frequency-dependent changes in local and distributed brain activity and explore the relationship between TI stimulation parameters and neurophysiological responses, providing in vivo evidence for parameter optimization of non-invasive deep brain stimulation.
- Conditions
- Epilepsy
- Being tested
- Temporal Interference Stimulation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference StimulationDevice
Participants will receive individualized temporal interference (TI) stimulation targeting one or two deep brain regions selected according to SEEG electrode coverage and individual neuroimaging data. Scalp electrode placement and stimulation intensity will be optimized using individualized finite-element modeling. Multiple beat-frequency conditions corresponding to delta, theta, alpha, beta, gamma, and high-gamma frequency ranges will be administered in randomized order. SEEG activity will be recorded before, during, and after stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Parameter Temporal Interference Stimulation | Experimental | Participants will receive multi-parameter temporal interference (TI) stimulation targeting one or two individualized deep brain regions selected according to SEEG electrode coverage and neuroimaging data. For each target, multiple stimulation frequencies will be administered in a randomized within-participant sequence, with SEEG activity recorded before, during, and after each stimulation condition. Repeated stimulation sequences and cortical-cortical evoked potential measurements will be performed to characterize the reproducibility and neurophysiological effects of TI stimulation. Receives: Device: Temporal Interference Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Pre-stimulation Baseline in SEEG Power Spectral Density
Measured: On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before each TI stimulation condition, during the 90-second stimulation period, and immediately after completion of the stimulation condition.
Secondary outcomes (1)
Change in Cortical-Cortical Evoked Potential (CCEP) Amplitude Following TI Stimulation
Measured: On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before and immediately after each 90-second TI stimulation condition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants are assigned to a single study arm and receive multiple temporal interference stimulation conditions in a within-participant design. For each selected deep brain target, multiple stimulation frequencies are administered in a randomized order, with SEEG activity recorded before, during, and after each stimulation condition.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sanbo Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhou, Beijing Sanbo Brain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790224
- Sponsor's protocol ID
- SBNK-YJ-2026-013-02
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stereoelectroencephalography-Based Study of Brain Functional Modulation by Multi-Parameter Temporal Interference Stimulation in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT07790224
- Acronym / sponsor ID
- SBNK-YJ-2026-013-02
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Sanbo Brain HospitalUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Aug 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.
This prospective exploratory interventional study aims to investigate the neurophysiological effects and safety of multi-parameter temporal interference (TI) stimulation in patients undergoing stereoelectroencephalography (SEEG) monitoring. Participants who have already undergone SEEG electrode implantation for clinical indications will receive non-invasive TI stimulation targeting selected deep brain regions according to their individual electrode coverage and neuroimaging data. Multiple stimulation frequencies will be tested while intracranial SEEG signals are recorded before, during, and after stimulation. The study will characterize frequency-dependent changes in local and distributed brain activity and explore the relationship between TI stimulation parameters and neurophysiological responses, providing in vivo evidence for parameter optimization of non-invasive deep brain stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants are assigned to a single study arm and receive multiple temporal interference stimulation conditions in a within-participant design. For each selected deep brain target, multiple stimulation frequencies are administered in a randomized order, with SEEG activity recorded before, during, and after each stimulation condition.
| Arm | Type | Receives |
|---|---|---|
| Multi-Parameter Temporal Interference Stimulation | Experimental | Device: Temporal Interference StimulationParticipants will receive multi-parameter temporal interference (TI) stimulation targeting one or two individualized deep brain regions selected according to SEEG electrode coverage and neuroimaging data. For each target, multiple stimulation frequencies will be administered in a randomized within-participant sequence, with SEEG activity recorded before, during, and after each stimulation condition. Repeated stimulation sequences and cortical-cortical evoked potential measurements will be performed to characterize the reproducibility and neurophysiological effects of TI stimulation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 70 years, inclusive, with no restriction on sex.
- Has undergone stereoelectroencephalography (SEEG) electrode implantation, with electrode contacts covering the target deep brain region(s), such as the thalamus, hippocampus, amygdala, or cingulate cortex.
- Is in the postoperative SEEG monitoring period, is clinically stable, and is able to comply with the study procedures.
- The participant or the participant's legally authorized representative is able to fully understand the purpose and procedures of the study and voluntarily provides written informed consent.
Key exclusion criteria (8 listed)
- Contraindications to magnetic resonance imaging (MRI), such as incompatible metallic implants or a cardiac pacemaker.
- Psychiatric disorders or severe cognitive impairment.
- Structural brain abnormalities, such as cerebral infarction, hydrocephalus, or severe thalamic atrophy.
- Other severe neurological disorders that may interfere with participation in the study.
- Medical or psychiatric contraindications, including recent myocardial infarction, cardiac arrhythmia, stroke, autonomic dysfunction, endocrine disorders, uncontrolled or difficult-to-control hypertension or hypotension, deep brain stimulation for other reasons, degenerative central nervous system disorders, or severe electrolyte disturbances.
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 Interference StimulationParticipants will receive individualized temporal interference (TI) stimulation targeting one or two deep brain regions selected according to SEEG electrode coverage and individual neuroimaging data. Scalp electrode placement and stimulation intensity will be optimized using individualized finite-element modeling. Multiple beat-frequency conditions corresponding to delta, theta, alpha, beta, gamma, and high-gamma frequency ranges will be administered in randomized order. SEEG activity will be recorded before, during, and after stimulation. | Device | Multi-Parameter Temporal Interference Stimulation |
Primary outcome
Change From Pre-stimulation Baseline in SEEG Power Spectral Density
Time frame: On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before each TI stimulation condition, during the 90-second stimulation period, and immediately after completion of the stimulation condition.
1 secondary outcome
Change in Cortical-Cortical Evoked Potential (CCEP) Amplitude Following TI Stimulation
Time frame: On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before and immediately after each 90-second TI stimulation condition.
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 27 Aug 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.
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 Stimulation in people with Epilepsy, run by Beijing Sanbo Brain 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 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 27 Aug 2026. 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 Jian Zhou (+86（10）85130669, zhoujian5151@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Pre-stimulation Baseline in SEEG Power Spectral Density (time frame: On each stimulation day (Day 1 and, if applicable, Day 2), assessed immediately before each TI stimulation condition, during the 90-second stimulation period, and immediately after completion of the stimulation condition.). 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 27 Aug 2026.