Drug Resistant EpilepsyTIENCT06708143
Temporal Interference for Drug Resistant Epilepsy
A study testing Temporal Interference in people with Drug Resistant Epilepsy, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This single-center prospective study aims to investigate the treatment efficacy of temporal interference (TI) in drug-resistant epilepsy patients aged 6-60. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- Temporal Interference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2024to 30 Nov 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants are between the ages of 6 -60 years of age.
- Patients must be clinically evaluated as having drug resistant epilepsy.
- Persistence of disabling seizures at least 2 times per months or greater.
- Informed consent signed.
Who cannot join
- Psychogenic non-epileptic seizures within 12 months;
- Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
- Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications; IQ < 55 or severe cognitive dysfunction, unable to complete the study; Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
- Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
- Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function; Pregnant, or planning to pregnant within 2 years; Participation in another clinical study within 3 months; Not suitable for enrollment as assessed by the multidisciplinary team of the center.
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
About this study
Official title: Noninvasive Temporal Interference Stimulation for the Treatment of Drug Resistant Epilepsy
This single-center prospective study aims to investigate the treatment efficacy of temporal interference (TI) in drug-resistant epilepsy patients aged 6-60.
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.
This study aims to investigate the treatment efficacy of TI deep brain stimulation by including drug-resistant patients aged 6-60. During and after TI stimulation, clinical and electrophysiology data will be recorded. Clinical, imaging and electrophysiology data will be analyzed and processed to advance the treatment of drug-resistant epilepsy.
- Conditions
- Drug Resistant Epilepsy
- Being tested
- Temporal Interference
- Keywords
- Temporal Interference, 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
Also called TI
Researchers apply temporal interference (TI) stimulation to the deep brain nuclei of drug resistant epilepsy patients.
| Study group | Role | What they receive |
|---|---|---|
| Temporal Interference | Experimental | The investigators perform temporal interference (TI) stimulation to patients with drug-resistant epilepsy. They observe clinical manifestations before, during, and after stimulation to investigate the efficiency of TI. Receives: Other: Temporal Interference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Frequency (SF28)
Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval:
SF28=(Total number of seizures in D days/D)*28. In addition, the baseline seizure frequency is defined as mean of 3- month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100*(double-blind SF28-baseline SF28)/baseline SF28.
Measured: Up to 1 year after TI stimulation
Secondary outcomes (6)
Seizure Responder Rate
The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.
Measured: Up to 1 year after TI stimulation
Life quality evaluation
Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score. The minimum and maximum values, and whether higher scores mean a better or worse outcome.
Measured: Up to 1 year after TI stimulation
Cognitive function evaluation (MMSE)
Percentage change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE score ranges from 0 to 30, with higher scores representing better cognitive function and lower scores indicating greater cognitive impairment.
Measured: Up to 1 year after TI stimulation
Cognitive function evaluation (MoCA)
Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score. The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function and lower scores suggesting greater cognitive impairment.
Measured: Up to 1 year after TI stimulation
Adverse Events
Rate of adverse events which were judged to be study-related throughout the study.
Measured: Up to 1 year after TI stimulation
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up.
Measured: Up to 1 year 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 posted27 Nov 2024
- Study start30 Nov 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant 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
- 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
- NCT06708143
- Sponsor's protocol ID
- 2024-316-002
- Acronym
- TIE
- Status last verified
- Jul 2026
- First submitted
- 23 Nov 2024
- Last updated
- 17 Jul 2026
- 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Temporal Interference Stimulation for the Treatment of Drug Resistant Epilepsy
- ClinicalTrials.gov ID
- NCT06708143
- Acronym / sponsor ID
- TIE / 2024-316-002
- Conditions
- Drug Resistant Epilepsy
- Keywords
- Temporal Interference, Drug Resistant Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 27 Nov 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 treatment efficacy of temporal interference (TI) in drug-resistant epilepsy patients aged 6-60.
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.
This study aims to investigate the treatment efficacy of TI deep brain stimulation by including drug-resistant patients aged 6-60. During and after TI stimulation, clinical and electrophysiology data will be recorded. Clinical, imaging and electrophysiology data will be analyzed and processed to advance the treatment of drug-resistant epilepsy.
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 InterferenceThe investigators perform temporal interference (TI) stimulation to patients with drug-resistant epilepsy. They observe clinical manifestations before, during, and after stimulation to investigate the efficiency of TI. |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Participants are between the ages of 6 -60 years of age.
- Patients must be clinically evaluated as having drug resistant epilepsy.
- Persistence of disabling seizures at least 2 times per months or greater.
- Informed consent signed.
Key exclusion criteria (5 listed)
- Psychogenic non-epileptic seizures within 12 months;
- Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
- Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications; IQ < 55 or severe cognitive dysfunction, unable to complete the study; Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
- Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
- Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function; Pregnant, or planning to pregnant within 2 years; Participation in another clinical study within 3 months; Not suitable for enrollment as assessed by the multidisciplinary team of the center.
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 InterferenceAlso: TIResearchers apply temporal interference (TI) stimulation to the deep brain nuclei of drug resistant epilepsy patients. | Other | Temporal Interference |
Primary outcome
Seizure Frequency (SF28)
Time frame: Up to 1 year after TI stimulation
Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)*28. In addition, the baseline seizure frequency is defined as mean of 3- month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100*(double-blind SF28-baseline SF28)/baseline SF28.
6 secondary outcomes
Seizure Responder Rate
Time frame: Up to 1 year after TI stimulation
Life quality evaluation
Time frame: Up to 1 year after TI stimulation
Cognitive function evaluation (MMSE)
Time frame: Up to 1 year after TI stimulation
Cognitive function evaluation (MoCA)
Time frame: Up to 1 year after TI stimulation
Adverse Events
Time frame: Up to 1 year after TI stimulation
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
Time frame: Up to 1 year after TI stimulation
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 17 Jul 2026.
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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 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 5 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 17 Jul 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 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?
Seizure Frequency (SF28) (time frame: Up to 1 year 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 17 Jul 2026.