An interventional study of Temporal Interference Stimulation and Direct Electrical Stimulation in Drug-Resistant Focal Epilepsy, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Duke University · Not applicable, Interventional, and Basic science
Among 78 studies in Drug Resistant Epilepsy with a site in United States — 30 open to participants now, 35 under way, 2 of them phase 3. Drug Resistant Epilepsy · United States.
Among the 78 studies in Drug Resistant Epilepsy with a site in United States, this one is the 30th largest by planned enrollment of the 67 interventional ones, is one of 7 that started in 2026, is one of 38 with no phase, reaches primary completion later than 32 of the 33 other live ones, and was the 76th registered.
257 studies on the registry are indexed under Drug Resistant Epilepsy; 108 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 202 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →30 of the 78 studies in Drug Resistant Epilepsy with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 66 Drug Resistant Epilepsy studies recruiting now, 26 (39%) set no upper age limit and 39 (59%) stop at 75 or younger; 25 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →78 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 7 started in 2026.
Median enrollment 27 across the 67 interventional studies, 100 across the 7 observational. Of the 34 that completed or were terminated, 14 (41%) have results posted.
20 of 78 have an industry lead sponsor. The 10 most frequent:
Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Duke University has 5 studies filed under Drug Resistant Epilepsy — fewer than ten, so there is no comparison to draw.
13 of the studies in Drug Resistant Epilepsy with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06132893Phase 3Biohaven Therapeutics Ltd.A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy | 2026-12 |
| NCT06443463Biohaven Therapeutics Ltd.Long-term Safety and Tolerability of BHV-7000 | 2026-12 |
| NCT06425029Dartmouth-Hitchcock Medical CenterSelf-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application | 2026-12 |
| NCT06138808Duke University5-SENSE Score Validation Study | 2027-01 |
| NCT05273970University of ArizonaElectrochemical and Electrophysiological Study | 2027-02 |
Among the 78 studies in Drug Resistant Epilepsy with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Remote resective/ablative brain surgery
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Temporal Interference stimulation delivered through scalp electrodes targeting the epileptic focus during wakefulness and/or natural NREM sleep.
Device: Temporal Interference Stimulation
Temporal Interference stimulation delivered through scalp electrodes targeting the thalamus during wakefulness and/or natural NREM sleep.
Device: Temporal Interference Stimulation
Subthreshold direct electrical stimulation delivered through implanted sEEG contacts.
Device: Direct Electrical Stimulation
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.
Subthreshold biphasic electrical stimulation delivered through implanted stereo-EEG contacts, remaining below thresholds for after-discharges and perceptual sensations.
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.
Time frame: 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.
Time frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
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.
Time frame: 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.
Time frame: 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
Time frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
Plan to share: Yes — Annotated preprocessed datasets and final research data will be shared.
Supporting information: Clinical study report, Analytic code
Time frame: IPD will be shared upon their initial online publication or 1-year following the end of the project.
Access criteria: Data Archive for the BRAIN Initiative (DABI)
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Aug 2031, 58 months after the start.
Of 90 non-industry interventional studies with no phase under Drug Resistant Epilepsy, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21. This study's planned 58 months is above that.
Counting every sponsor, half of 102 studies reached it within 34 months; a quarter within 21 and three quarters within 50.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Oct 15, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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