Recruiting

Temporal Interference

Sponsor:

Duke University

Code:

NCT07434986

Conditions

Temporal Lobe Epilepsy (TLE)

Drug Resistant Epilepsy

Sleep

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi

Study Details

Brief summary:

The goal of this clinical trial is to gauge whether overnight, non-invasive temporal interference (TI) stimulation aimed at the hippocampus can reduce abnormal brain activity linked to seizures and improve sleep in adults with drug-resistant temporal lobe epilepsy. The main questions are:

Does overnight TI stimulation lower seizure-related EEG activity during sleep?

Does overnight TI stimulation improve sleep quality and sleep patterns measured overnight in the lab?

Researchers will compare each participant's nights without stimulation to nights with active stimulation, and will also look at a night after stimulation ends to see whether any changes last.

Participants will:

Stay in-lab for six days for overnight sleep and EEG monitoring

Have one night of monitoring without stimulation

Receive TI stimulation during sleep for several nights

Have another night of monitoring without stimulation after the stimulation nights

Complete brief questionnaires and thinking/memory tasks before and after the stimulation nights

Be checked for side effects and comfort during the study and at follow-up

Conditions

Temporal Lobe Epilepsy (TLE)

Drug Resistant Epilepsy

Sleep

Study ID

NCT07434986

Start date

Oct 15, 2026

Status verified date

Feb, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 - 70 years
  • Diagnosis of focal drug-resistant temporal lobe epilepsy
  • Candidate for in-laboratory overnight monitoring with PSG and scalp EEG, with ability to comply with study procedures
  • Stable antiseizure medication regimen for at least 1 week prior to admission
  • Capacity to provide consent

Exclusion Criteria:

  • Generalized epilepsy syndromes or primary generalized seizures
  • Recent status epilepticus, seizure clusters requiring emergency intervention, or other features indicating unacceptable risk for monitored participation
  • Uncontrolled psychiatric illness (e.g., acute psychosis, severe untreated depression with high suicide risk)
  • Implanted electronic or metallic devices incompatible with TI (e.g., certain pacemakers, cochlear implants) as per device manual
  • Severe obstructive sleep apnea requiring immediate CPAP initiation and not yet treated
  • Dermatologic disease at electrode sites or known contact allergy to electrode materials
  • Pregnancy or breastfeeding
  • Concurrent enrollment in other interventional neuromodulation or pharmacological trials likely to confound EEG or sleep outcomes

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Group: Overnight TI Stimulation and Within-Subject No-Stimulation Control Nights

Single-group, within-subject protocol with in-laboratory overnight PSG and scalp EEG. Participants complete one baseline night with no stimulation, followed by three consecutive nights of active overnight temporal interference (TI) stimulation targeting bilateral hippocampi, then one post-treatment night with no stimulation to assess persistence. Evening and morning EEG biomarker recordings are collected throughout, with safety/tolerability monitoring and pre/post cognitive and mood assessments.

Interventions

Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi

Non-invasive temporal interference (TI) electrical stimulation delivered overnight to target the bilateral hippocampi during in-laboratory polysomnography and scalp EEG monitoring.

Stimulation is applied via a multi-channel, current-controlled stimulator using a scalp electrode montage planned with MRI-guided modeling. TI is delivered continuously from lights-off to lights-on for three consecutive nights, with gradual ramp-up and ramp-down at the start and end of each session. Stimulation parameters use kilohertz carrier currents arranged to produce an amplitude-modulated envelope at 130 Hz at each hippocampal target, with current adjusted within preset safety limits based on tolerability and impedance.

Primary outcome measure

  • Change in Overnight Interictal Epileptiform Discharge (IED) Rate on Scalp EEG [ Time Frame: Baseline (Night 1, no stimulation) and during active TI stimulation nights (average of Nights 2-4, overnight sleep period). ]

Central Contacts and Locations

Central contacts

Birgit Frauscher, MD, PhD

919-613-9386birgit.frauscher@duke.edu

Bruna Kfoury, Pharm.D.

470-312-7573bk282@duke.edu

Locations

Anphy Lab - Inside Hock Plaza

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Birgit Frauscher, MD, PhD

919-613-9386birgit.frauscher@duke.edu

Bruna Kfoury, Pharm.D.

470-312-7573bk282@duke.edu

More Information

Sponsor

Duke University

Last update posted

Oct 16, 2026

Last verified

Feb, 2026

Keywords

  • Epilepsy
  • Temporal Lobe
  • Epilepsy and Sleep
  • Drug Resistant Epilepsy
  • Temporal Interference
  • Stimulation
  • Hippocampus
  • Sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Duke University on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.