Recruiting

Temporal Interference

Sponsor:

Duke University

Code:

NCT07764718

Conditions

Drug-Resistant Focal Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Temporal Interference Stimulation

Direct Electrical Stimulation

Study Details

Brief 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. 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

Study ID

NCT07764718

Start date

Sep 16, 2026

Status verified date

Aug, 2026

Completion date

Aug 14, 2031

Anticipated

Primary completion date

Aug 14, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

\- Remote resective/ablative brain surgery

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Temporal Interference Stimulation to Epileptic Focus

Temporal Interference stimulation delivered through scalp electrodes targeting the epileptic focus during wakefulness and/or natural NREM sleep.

experimental: Temporal Interference Stimulation to Thalamus

Temporal Interference stimulation delivered through scalp electrodes targeting the thalamus during wakefulness and/or natural NREM sleep.

active comparator: Direct Electrical Stimulation

Subthreshold direct electrical stimulation delivered through implanted sEEG contacts.

Interventions

Temporal Interference 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.

Direct Electrical Stimulation

Subthreshold biphasic electrical stimulation delivered through implanted stereo-EEG contacts, remaining below thresholds for after-discharges and perceptual sensations.

Primary outcome measure

  • Interictal epileptiform discharge rate [ Time Frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation ]
  • Single-unit firing rate [ Time Frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation ]

Central Contacts and Locations

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Birgit Frauscher, MD

919-597-1523birgit.frauscher@duke.edu

Bruna Kfoury, Pharm.D.

470-312-7573bk282@duke.edu

More Information

Sponsor

Duke University

Last update posted

Oct 15, 2026

Last verified

Aug, 2026

Keywords

  • Drug-Resistant Epilepsy
  • Temporal Interference Stimulation
  • Stereo-EEG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Duke University on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.