Drug-Resistant Focal EpilepsyNCT07764718
Temporal Interference Brain Stimulation for Adults With Drug-Resistant Epilepsy Undergoing Stereo-EEG Monitoring
A study testing Temporal Interference Stimulation and Direct Electrical Stimulation in people with Drug-Resistant Focal Epilepsy, run by Duke University at 1 site in United States.
Trial summary
This study evaluates whether a non-invasive brain stimulation technique called Temporal Interference (TI) can reduce epilepsy-related abnormal brain activity and influence sleep-related brain rhythms in adults with focal drug-resistant epilepsy undergoing stereo-EEG monitoring for clinical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-Resistant Focal Epilepsy
- What is being tested?
- Temporal Interference Stimulation and Direct Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2026to 14 Aug 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with focal DRE who will undergo presurgical evaluation with sEEG
- Availability of at least one sEEG electrode inserted into the thalamus for clinical purposes
- sEEG performed with the indication to identify one single epileptic focus
- Ability to provide written informed consent and comply with the study protocol
Who cannot join
- Remote resective/ablative brain surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
Birgit Frauscher, MD, 919-597-1523, birgit.frauscher@duke.edu
Bruna Kfoury, Pharm.D., 470-312-7573, bk282@duke.edu
About this study
Official title: Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy - Effect of Temporal Interference on Biomarkers of Epilepsy
This study evaluates whether a non-invasive brain stimulation technique called Temporal Interference (TI) can reduce epilepsy-related abnormal brain activity and influence sleep-related brain rhythms in adults with focal drug-resistant epilepsy undergoing stereo-EEG monitoring for clinical care. Up to 30 participants will complete stimulation sessions during wakefulness and, when possible, natural non-REM sleep. Brain activity will be recorded using scalp EEG and implanted sEEG electrodes before, during, and after TI stimulation. Some participants may also receive subthreshold direct stimulation through implanted electrodes for comparison. The study aims to determine whether TI can reduce epilepsy biomarkers, alter sleep-related brain activity, and compare favorably with conventional direct electrical stimulation while remaining within established safety limits.
- Conditions
- Drug-Resistant Focal Epilepsy
- Being tested
- Temporal Interference Stimulation, Direct Electrical Stimulation
- Keywords
- Drug-Resistant Epilepsy, Temporal Interference Stimulation, Stereo-EEG
- 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 Interference StimulationDevice
Non-invasive electrical stimulation delivered through scalp electrodes using paired sinusoidal currents with differential carrier frequencies to create a low-frequency envelope targeting deep brain structures including the epileptic focus or thalamus.
Direct Electrical StimulationDevice
Subthreshold biphasic electrical stimulation delivered through implanted stereo-EEG contacts, remaining below thresholds for after-discharges and perceptual sensations.
| Study group | Role | What they receive |
|---|---|---|
| Temporal Interference Stimulation to Epileptic Focus | Experimental | Temporal Interference stimulation delivered through scalp electrodes targeting the epileptic focus during wakefulness and/or natural NREM sleep. Receives: Device: Temporal Interference Stimulation |
| Temporal Interference Stimulation to Thalamus | Experimental | Temporal Interference stimulation delivered through scalp electrodes targeting the thalamus during wakefulness and/or natural NREM sleep. Receives: Device: Temporal Interference Stimulation |
| Direct Electrical Stimulation | Active comparator | Subthreshold direct electrical stimulation delivered through implanted sEEG contacts. Receives: Device: Direct Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interictal epileptiform discharge rate
The interictal epileptiform discharge (IED) rate per minute is a classical biomarker of epilepsy. It is derived from sEEG macro- and microcontacts.
Measured: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
Single-unit firing rate
single unit firing rate is the number of action potentials ("spikes") that an isolated neuron emits per second. It is derived from sEEG microcontacts.
Measured: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
Secondary outcomes (3)
High-frequency oscillations
The high-frequency oscillation rate per minute (frequency >80 Hz) is an alternative biomarker of epilepsy. it is derived from sEEG macro- and microcontacts.
Measured: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
local field potential spectral power
The power of local field potentials in defined frequency bands (theta: 4-8 Hz, beta: 13-30 Hz, gamma: 30-100 Hz) will be measured from macro- and microcontacts.
Measured: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
Sleep microstructure
Sleep microstructure is comprised of sleep spindles (sleep specific transients of 10-16 Hz exceeding 0.5 seconds) and slow oscillations (delta wave transients < 0.5 Hz) measured in scalp EEG and sEEG macrocontacts. Rates are provided per minute
Measured: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start16 Sep 2026
- Primary completion14 Aug 2031 (estimated)
- Study completion14 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Resistant Focal EpilepsyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Birgit Frauscher, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764718
- Sponsor's protocol ID
- PRO00119776
- Other IDs
- 1R56NS148323-01
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Annotated preprocessed datasets and final research data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy - Effect of Temporal Interference on Biomarkers of Epilepsy
- ClinicalTrials.gov ID
- NCT07764718
- Acronym / sponsor ID
- PRO00119776
- Conditions
- Drug-Resistant Focal Epilepsy
- Keywords
- Drug-Resistant Epilepsy, Temporal Interference Stimulation, Stereo-EEG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- 14 Aug 2031 (estimated)
- Study completion
- 14 Aug 2031 (estimated)
- First posted
- 14 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 study evaluates whether a non-invasive brain stimulation technique called Temporal Interference (TI) can reduce epilepsy-related abnormal brain activity and influence sleep-related brain rhythms in adults with focal drug-resistant epilepsy undergoing stereo-EEG monitoring for clinical care. Up to 30 participants will complete stimulation sessions during wakefulness and, when possible, natural non-REM sleep. Brain activity will be recorded using scalp EEG and implanted sEEG electrodes before, during, and after TI stimulation. Some participants may also receive subthreshold direct stimulation through implanted electrodes for comparison. The study aims to determine whether TI can reduce epilepsy biomarkers, alter sleep-related brain activity, and compare favorably with conventional direct electrical stimulation while remaining within established safety limits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Temporal Interference Stimulation to Epileptic Focus | Experimental | Device: Temporal Interference StimulationTemporal Interference stimulation delivered through scalp electrodes targeting the epileptic focus during wakefulness and/or natural NREM sleep. |
| Temporal Interference Stimulation to Thalamus | Experimental | Device: Temporal Interference StimulationTemporal Interference stimulation delivered through scalp electrodes targeting the thalamus during wakefulness and/or natural NREM sleep. |
| Direct Electrical Stimulation | Active comparator | Device: Direct Electrical StimulationSubthreshold direct electrical stimulation delivered through implanted sEEG contacts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with focal DRE who will undergo presurgical evaluation with sEEG
- Availability of at least one sEEG electrode inserted into the thalamus for clinical purposes
- sEEG performed with the indication to identify one single epileptic focus
- Ability to provide written informed consent and comply with the study protocol
Key exclusion criteria (1 listed)
- Remote resective/ablative brain surgery
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 StimulationNon-invasive electrical stimulation delivered through scalp electrodes using paired sinusoidal currents with differential carrier frequencies to create a low-frequency envelope targeting deep brain structures including the epileptic focus or thalamus. | Device | Temporal Interference Stimulation to Epileptic Focus, Temporal Interference Stimulation to Thalamus |
| Direct Electrical StimulationSubthreshold biphasic electrical stimulation delivered through implanted stereo-EEG contacts, remaining below thresholds for after-discharges and perceptual sensations. | Device | Direct Electrical Stimulation |
Primary outcome
Interictal epileptiform discharge rate
Time frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
The interictal epileptiform discharge (IED) rate per minute is a classical biomarker of epilepsy. It is derived from sEEG macro- and microcontacts.
Single-unit firing rate
Time frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
single unit firing rate is the number of action potentials ("spikes") that an isolated neuron emits per second. It is derived from sEEG microcontacts.
3 secondary outcomes
High-frequency oscillations
Time frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
local field potential spectral power
Time frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
Sleep microstructure
Time frame: 20-minute baseline, 20-minute stimulation, 20-minute post-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 15 Oct 2026.
- Individual participant dataSharing planned: Yes. Annotated preprocessed datasets and final research data will be shared.
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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.
Birgit Frauscher principal investigator
Duke University
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 and Direct Electrical Stimulation in people with Drug-Resistant Focal Epilepsy, run by Duke University at 1 site in United States.
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 15 Oct 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 United States. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interictal epileptiform discharge rate (time frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation). The study lists 2 primary outcomes in all. 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 15 Oct 2026.