Deep Brain StimulationNCT06663969
Evaluating Modulation Effects of Temporal Interference Using SEEG
A study testing Temporal Interference in people with Deep Brain Stimulation and Drug Resistant Epilepsy, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This single-center prospective study aims to investigate the electrophysiological mechanisms of temporal interference (TI) in humans by analyzing clinical, imaging, and electrophysiological data from patients aged 14-60 with drug-resistant epilepsy. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Deep Brain Stimulation, Drug Resistant Epilepsy
- What is being tested?
- Temporal Interference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2024to Oct 2025
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of drug-resistant epilepsy;
- No severe systemic diseases;
- Implantation of stereotactic electrodes;
- Agreement to participate in this study and signs the informed consent form.
Who cannot join
- Hematoma at the scalp electrode site or fluid accumulation under the electrode after intracranial electrode placement.
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, 1 recruiting
- Recruiting
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053
Liankun Ren, MD, +86 13681576621, renlk2022@outlook.com
Liankun Ren, MD
About this study
This single-center prospective study aims to investigate the electrophysiological mechanisms of temporal interference (TI) in humans by analyzing clinical, imaging, and electrophysiological data from patients aged 14-60 with drug-resistant epilepsy.
Read the detailed description
Temporal Interference (TI) technology is a novel non-invasive method for deep brain stimulation (DBS). By generating an overlapping electric field from safe currents, TI creates focused stimulation in targeted deep brain areas. This approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive DBS for clinical treatments.
Stereoelectroencephalography (SEEG) is a method for recording electrical activity from deep brain structures using implanted depth electrodes to provide a three-dimensional view of neuronal activity.
This study aims to investigate the electrophysiological mechanisms of temporal interference (TI) deep brain stimulation by including patients aged 14-60 with implanted intracranial electrodes. During and after TI stimulation, electrophysiological and clinical data will be recorded. Clinical, imaging, and electrophysiological data will be analyzed and processed to advance understanding of TI's effects in deep brain stimulation.
- Conditions
- Deep Brain Stimulation, Drug Resistant Epilepsy
- Being tested
- Temporal Interference
- Keywords
- Temporal Interference, Stereoelectroencephalography, Drug Resistant Epilepsy
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal InterferenceOther
Researchers applied temporal interference (TI) stimulation to the deep brain nuclei of patients who had undergone SEEG monitoring, recording changes in electrical activity detected by SEEG.
| Study group | Role | What they receive |
|---|---|---|
| Temporal Interference | Experimental | The investigators performed temporal interference (TI) stimulation to patients with drug-resistant epilepsy undergoing SEEG monitoring. They observed electrophysiological activity and clinical manifestations before, during, and after stimulation to investigate the electrophysiological mechanisms of TI. Receives: Other: Temporal Interference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological changes
Electrophysiological waveform changes recorded by stereoelectroencephalography (SEEG) before, during, and after TI stimulation.
Measured: During the trial(up to 3 hours for each subject)
Secondary outcomes (1)
Patient's subjective feelings and symptoms
Researchers categorized patients' clinical responses as normal, mild, moderate, or severe based on their subjective clinical response.
Measured: During the trial(up to 3 hours for each subject)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start4 Nov 2024
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Brain StimulationStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liankun_Ren, Xuanwu Hospital, Beijing
- Investigators
- Liankun Ren, MD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663969
- Sponsor's protocol ID
- 2024-258-002
- Status last verified
- Feb 2025
- First submitted
- 26 Oct 2024
- Last updated
- 5 Feb 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Modulation Effects of Temporal Interference Using SEEG
- ClinicalTrials.gov ID
- NCT06663969
- Acronym / sponsor ID
- 2024-258-002
- Conditions
- Deep Brain Stimulation, Drug Resistant Epilepsy
- Keywords
- Temporal Interference, Stereoelectroencephalography, Drug Resistant Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 29 Oct 2024 (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 single-center prospective study aims to investigate the electrophysiological mechanisms of temporal interference (TI) in humans by analyzing clinical, imaging, and electrophysiological data from patients aged 14-60 with drug-resistant epilepsy.
Detailed description
Temporal Interference (TI) technology is a novel non-invasive method for deep brain stimulation (DBS). By generating an overlapping electric field from safe currents, TI creates focused stimulation in targeted deep brain areas. This approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive DBS for clinical treatments.
Stereoelectroencephalography (SEEG) is a method for recording electrical activity from deep brain structures using implanted depth electrodes to provide a three-dimensional view of neuronal activity.
This study aims to investigate the electrophysiological mechanisms of temporal interference (TI) deep brain stimulation by including patients aged 14-60 with implanted intracranial electrodes. During and after TI stimulation, electrophysiological and clinical data will be recorded. Clinical, imaging, and electrophysiological data will be analyzed and processed to advance understanding of TI's effects in deep brain stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporal Interference | Experimental | Other: Temporal InterferenceThe investigators performed temporal interference (TI) stimulation to patients with drug-resistant epilepsy undergoing SEEG monitoring. They observed electrophysiological activity and clinical manifestations before, during, and after stimulation to investigate the electrophysiological mechanisms of TI. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of drug-resistant epilepsy;
- No severe systemic diseases;
- Implantation of stereotactic electrodes;
- Agreement to participate in this study and signs the informed consent form.
Key exclusion criteria (1 listed)
- Hematoma at the scalp electrode site or fluid accumulation under the electrode after intracranial electrode placement.
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 InterferenceResearchers applied temporal interference (TI) stimulation to the deep brain nuclei of patients who had undergone SEEG monitoring, recording changes in electrical activity detected by SEEG. | Other | Temporal Interference |
Primary outcome
Electrophysiological changes
Time frame: During the trial(up to 3 hours for each subject)
Electrophysiological waveform changes recorded by stereoelectroencephalography (SEEG) before, during, and after TI stimulation.
1 secondary outcome
Patient's subjective feelings and symptoms
Time frame: During the trial(up to 3 hours for each subject)
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 5 Feb 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.
Liankun Ren, MD principal investigator
Xuanwu Hospital, Beijing
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 Deep Brain Stimulation and Drug Resistant Epilepsy, run by Xuanwu Hospital, Beijing 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 1 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: looking for participants now, as of the sponsor's last update on 5 Feb 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 Liankun Ren, MD (+86 13681576621, renlk2022@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrophysiological changes (time frame: During the trial(up to 3 hours for each subject)). 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 5 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.