Temporal Lobe Epilepsy (TLE)TI-HPC-TLENCT07434986
Overnight TI in TLE
A study testing Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi in people with Temporal Lobe Epilepsy (TLE) and Drug Resistant Epilepsy, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Temporal Lobe Epilepsy (TLE), Drug Resistant Epilepsy, Sleep
- What is being tested?
- Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 30 Oct 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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
Anphy Lab - Inside Hock Plaza
Durham, North Carolina, 27705
Birgit Frauscher, MD, PhD, 919-613-9386, birgit.frauscher@duke.edu
Bruna Kfoury, Pharm.D., 470-312-7573, bk282@duke.edu
About this study
Official title: Overnight Temporal Interference Stimulation of Bilateral Hippocampi to Reduce Epileptogenic Biomarkers and Improve Sleep in Temporal Lobe Epilepsy
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?
Read more
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
- Being tested
- Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi
- Keywords
- Epilepsy, Temporal Lobe, Epilepsy and Sleep, Drug Resistant Epilepsy, Temporal Interference, Stimulation, Hippocampus, Sleep
- Medical subject headings
- Epilepsy, Temporal Lobe, Drug Resistant Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral HippocampiDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Group: Overnight TI Stimulation and Within-Subject No-Stimulation Control Nights | Experimental | 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. Receives: Device: Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overnight Interictal Epileptiform Discharge (IED) Rate on Scalp EEG
Overnight interictal epileptiform discharge (IED) rate (spikes per minute) computed from scalp EEG during sleep. IEDs will be identified using a standardized scoring pipeline, and the rate will be calculated as total IED count divided by total minutes of sleep (PSG-defined sleep time). Lower values indicate fewer epileptiform discharges (improvement). The primary comparison is baseline no-stimulation night versus the average of the active TI stimulation nights.
Measured: Baseline (Night 1, no stimulation) and during active TI stimulation nights (average of Nights 2-4, overnight sleep period).
Secondary outcomes (11)
PSG sleep outcomes - time in REM (rapid eye movement)
Overnight polysomnography (PSG) measures of sleep stages and sleep quality/continuity. Higher sleep efficiency and lower fragmentation indicate improvement.
Measured: Night 1 (no stimulation), Nights 2-4 (active TI), and Night 5 (no stimulation), assessed over each overnight sleep period.
PSG sleep outcomes - efficiency
Overnight polysomnography (PSG) measures of sleep stages and sleep quality/continuity. Higher sleep efficiency and lower fragmentation indicate improvement.
Measured: Night 1 (no stimulation), Nights 2-4 (active TI), and Night 5 (no stimulation), assessed over each overnight sleep period.
PSG sleep outcomes - wake after sleep onset
Overnight polysomnography (PSG) measures of sleep stages and sleep quality/continuity. Higher sleep efficiency and lower fragmentation indicate improvement.
Measured: Night 1 (no stimulation), Nights 2-4 (active TI), and Night 5 (no stimulation), assessed over each overnight sleep period.
PSG sleep outcomes - arousal index
Overnight polysomnography (PSG) measures of sleep stages and sleep quality/continuity. Higher sleep efficiency and lower fragmentation indicate improvement.
Measured: Night 1 (no stimulation), Nights 2-4 (active TI), and Night 5 (no stimulation), assessed over each overnight sleep period.
Morning and evening scalp EEG biomarker burden
Standardized scalp EEG recordings collected twice daily to quantify seizure-related biomarker burden (e.g., IED rate) and track day-to-day changes during the monitoring week. Lower biomarker burden indicates improvement.
Measured: Evening (~20:00) and morning (~10:00) assessments across the in-lab week (Days 1-6)
Persistence of biomarker changes after stimulation ends - Post treatment night
Biomarker burden on the post-treatment no-stimulation night to assess whether overnight TI effects carry over after stimulation stops, compared with baseline and stimulation nights. Lower biomarker burden indicates improvement
Measured: Night 5 (no stimulation; overnight sleep period), compared with Night 1 and the average of Nights 2-4
Cognitive performance - Rey/Taylor Figure-copy and immediate recall
Scores on Rey/Taylor Figure copy and immediate recall to assess short-term changes in visuospatial construction and memory before versus after the stimulation block. Higher scores indicate better performance
Measured: Pre-stimulation (baseline, prior to Night 2) and post-stimulation (after Night 4 or on Day 6)
Psychiatric symptom measures - Beck Anxiety Inventory (BAI)
Scores on validated anxiety and depression scales to assess changes in symptoms before versus after the stimulation block. Lower scores indicate fewer symptoms.
Measured: Pre-stimulation (baseline, prior to Night 2) and post-stimulation (after Night 4 or on Day 6)
Psychiatric symptom measures - Hamilton Anxiety Rating Scale (HAM-A)
Scores on validated anxiety and depression scales to assess changes in symptoms before versus after the stimulation block. Lower scores indicate fewer symptoms.
Measured: Pre-stimulation (baseline, prior to Night 2) and post-stimulation (after Night 4 or on Day 6)
Psychiatric symptom measures - Hamilton Depression Rating Scale (HAM-D)
Scores on validated anxiety and depression scales to assess changes in symptoms before versus after the stimulation block. Lower scores indicate fewer symptoms.
Measured: Pre-stimulation (baseline, prior to Night 2) and post-stimulation (after Night 4 or on Day 6)
Safety and tolerability - adverse events, skin checks, discomfort
Frequency, type, and severity of device- and study-related adverse events (e.g., skin irritation, headache, dizziness, sleep disturbance), plus tolerability/comfort checks during the admission and at follow-up
Measured: During in-lab monitoring (Nights 1-5) and follow-up (Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Temporal Lobe Epilepsy (TLE)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic
- Responsible party
- Sponsor
- Investigators
- Birgit Frauscher, MD / PD, Principal investigator, Duke UniversityAdam Williamson, PhD, Principal investigator, St. Anne's University Hospital, Brno Czechia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434986
- Sponsor's protocol ID
- Pro00119826
- Acronym
- TI-HPC-TLE
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Acerbo E, Jegou A, Luff C, Dzialecka P, Botzanowski B, Missey F, Ngom I, Lagarde S, Bartolomei F, Cassara A, Neufeld E, Jirsa V, Carron R, Grossman N, Williamson A. Focal non-invasive deep-brain stimulation with temporal interference for the suppression of epileptic biomarkers. Front Neurosci. 2022 Aug 17;16:945221. doi: 10.3389/fnins.2022.945221. eCollection 2022.
PubMed 36061593Roehri N, Pizzo F, Lagarde S, Lambert I, Nica A, McGonigal A, Giusiano B, Bartolomei F, Benar CG. High-frequency oscillations are not better biomarkers of epileptogenic tissues than spikes. Ann Neurol. 2018 Jan;83(1):84-97. doi: 10.1002/ana.25124.
PubMed 29244226Colombet B, Woodman M, Badier JM, Benar CG. AnyWave: a cross-platform and modular software for visualizing and processing electrophysiological signals. J Neurosci Methods. 2015 Mar 15;242:118-26. doi: 10.1016/j.jneumeth.2015.01.017. Epub 2015 Jan 19.
PubMed 25614386McLachlan RS, Pigott S, Tellez-Zenteno JF, Wiebe S, Parrent A. Bilateral hippocampal stimulation for intractable temporal lobe epilepsy: impact on seizures and memory. Epilepsia. 2010 Feb;51(2):304-7. doi: 10.1111/j.1528-1167.2009.02332.x. Epub 2009 Oct 8.
PubMed 19817814Voroslakos M, Takeuchi Y, Brinyiczki K, Zombori T, Oliva A, Fernandez-Ruiz A, Kozak G, Kincses ZT, Ivanyi B, Buzsaki G, Berenyi A. Direct effects of transcranial electric stimulation on brain circuits in rats and humans. Nat Commun. 2018 Feb 2;9(1):483. doi: 10.1038/s41467-018-02928-3.
PubMed 29396478Velasco AL, Velasco F, Velasco M, Trejo D, Castro G, Carrillo-Ruiz JD. Electrical stimulation of the hippocampal epileptic foci for seizure control: a double-blind, long-term follow-up study. Epilepsia. 2007 Oct;48(10):1895-903. doi: 10.1111/j.1528-1167.2007.01181.x. Epub 2007 Jul 18.
PubMed 17634064Missey F, Acerbo E, Dickey A, Trajlinek J, Studnicka O, Lubrano C, De Araujo E Silva M, Brady E, Vsiansky V, Szabo JP, Dolezalova I, Fabo D, Pail M, Gutekunst CA, Migliore R, Migliore M, Lagarde S, Carron R, Karimi F, Astorga R, Cassara A, Kuster N, Neufeld E, Bartolomei F, Pedersen NP, Gross R, Jirsa V, Drane D, Brazdil M, Williamson A. Non-invasive Temporal Interference Stimulation of the Hippocampus Suppresses Epileptic Biomarkers in Patients with Epilepsy: Biophysical Differences between Kilohertz and Amplitude Modulated Stimulation. medRxiv [Preprint]. 2025 Jan 14:2024.12.05.24303799. doi: 10.1101/2024.12.05.24303799.
PubMed 39711722Violante IR, Alania K, Cassara AM, Neufeld E, Acerbo E, Carron R, Williamson A, Kurtin DL, Rhodes E, Hampshire A, Kuster N, Boyden ES, Pascual-Leone A, Grossman N. Non-invasive temporal interference electrical stimulation of the human hippocampus. Nat Neurosci. 2023 Nov;26(11):1994-2004. doi: 10.1038/s41593-023-01456-8. Epub 2023 Oct 19.
PubMed 37857775Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.
PubMed 28575667
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overnight Temporal Interference Stimulation of Bilateral Hippocampi to Reduce Epileptogenic Biomarkers and Improve Sleep in Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT07434986
- Acronym / sponsor ID
- TI-HPC-TLE / Pro00119826
- Conditions
- Temporal Lobe Epilepsy (TLE), Drug Resistant Epilepsy, Sleep
- Keywords
- Epilepsy, Temporal Lobe, Epilepsy and Sleep, Drug Resistant Epilepsy, Temporal Interference, Stimulation, Hippocampus, Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 27 Feb 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group: Overnight TI Stimulation and Within-Subject No-Stimulation Control Nights | Experimental | Device: Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral HippocampiSingle-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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral HippocampiNon-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. | Device | Single Group: Overnight TI Stimulation and Within-Subject No-Stimulation Control Nights |
Primary outcome
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).
Overnight interictal epileptiform discharge (IED) rate (spikes per minute) computed from scalp EEG during sleep. IEDs will be identified using a standardized scoring pipeline, and the rate will be calculated as total IED count divided by total minutes of sleep (PSG-defined sleep time). Lower values indicate fewer epileptiform discharges (improvement). The primary comparison is baseline no-stimulation night versus the average of the active TI stimulation nights.
11 secondary outcomes
PSG sleep outcomes - time in REM (rapid eye movement)
Time frame: Night 1 (no stimulation), Nights 2-4 (active TI), and Night 5 (no stimulation), assessed over each overnight sleep period.
PSG sleep outcomes - efficiency
Time frame: Night 1 (no stimulation), Nights 2-4 (active TI), and Night 5 (no stimulation), assessed over each overnight sleep period.
PSG sleep outcomes - wake after sleep onset
Time frame: Night 1 (no stimulation), Nights 2-4 (active TI), and Night 5 (no stimulation), assessed over each overnight sleep period.
PSG sleep outcomes - arousal index
Time frame: Night 1 (no stimulation), Nights 2-4 (active TI), and Night 5 (no stimulation), assessed over each overnight sleep period.
Morning and evening scalp EEG biomarker burden
Time frame: Evening (~20:00) and morning (~10:00) assessments across the in-lab week (Days 1-6)
Persistence of biomarker changes after stimulation ends - Post treatment night
Time frame: Night 5 (no stimulation; overnight sleep period), compared with Night 1 and the average of Nights 2-4
Cognitive performance - Rey/Taylor Figure-copy and immediate recall
Time frame: Pre-stimulation (baseline, prior to Night 2) and post-stimulation (after Night 4 or on Day 6)
Psychiatric symptom measures - Beck Anxiety Inventory (BAI)
Time frame: Pre-stimulation (baseline, prior to Night 2) and post-stimulation (after Night 4 or on Day 6)
Psychiatric symptom measures - Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Pre-stimulation (baseline, prior to Night 2) and post-stimulation (after Night 4 or on Day 6)
Psychiatric symptom measures - Hamilton Depression Rating Scale (HAM-D)
Time frame: Pre-stimulation (baseline, prior to Night 2) and post-stimulation (after Night 4 or on Day 6)
Safety and tolerability - adverse events, skin checks, discomfort
Time frame: During in-lab monitoring (Nights 1-5) and follow-up (Day 7)
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 16 Oct 2026.
- Background: PubMed 36061593Acerbo E, Jegou A, Luff C, Dzialecka P, Botzanowski B, Missey F, Ngom I, Lagarde S, Bartolomei F, Cassara A, Neufeld E, Jirsa V, Carron R, Grossman N, Williamson A. Focal non-invasive deep-brain stimulation with temporal interference for the suppression of epileptic biomarkers. Front Neurosci. 2022 Aug 17;16:945221. doi: 10.3389/fnins.2022.945221. eCollection 2022.
- Background: PubMed 29244226Roehri N, Pizzo F, Lagarde S, Lambert I, Nica A, McGonigal A, Giusiano B, Bartolomei F, Benar CG. High-frequency oscillations are not better biomarkers of epileptogenic tissues than spikes. Ann Neurol. 2018 Jan;83(1):84-97. doi: 10.1002/ana.25124.
- Background: PubMed 25614386Colombet B, Woodman M, Badier JM, Benar CG. AnyWave: a cross-platform and modular software for visualizing and processing electrophysiological signals. J Neurosci Methods. 2015 Mar 15;242:118-26. doi: 10.1016/j.jneumeth.2015.01.017. Epub 2015 Jan 19.
- Background: PubMed 19817814McLachlan RS, Pigott S, Tellez-Zenteno JF, Wiebe S, Parrent A. Bilateral hippocampal stimulation for intractable temporal lobe epilepsy: impact on seizures and memory. Epilepsia. 2010 Feb;51(2):304-7. doi: 10.1111/j.1528-1167.2009.02332.x. Epub 2009 Oct 8.
- Background: PubMed 29396478Voroslakos M, Takeuchi Y, Brinyiczki K, Zombori T, Oliva A, Fernandez-Ruiz A, Kozak G, Kincses ZT, Ivanyi B, Buzsaki G, Berenyi A. Direct effects of transcranial electric stimulation on brain circuits in rats and humans. Nat Commun. 2018 Feb 2;9(1):483. doi: 10.1038/s41467-018-02928-3.
- Background: PubMed 17634064Velasco AL, Velasco F, Velasco M, Trejo D, Castro G, Carrillo-Ruiz JD. Electrical stimulation of the hippocampal epileptic foci for seizure control: a double-blind, long-term follow-up study. Epilepsia. 2007 Oct;48(10):1895-903. doi: 10.1111/j.1528-1167.2007.01181.x. Epub 2007 Jul 18.
- Background: PubMed 39711722Missey F, Acerbo E, Dickey A, Trajlinek J, Studnicka O, Lubrano C, De Araujo E Silva M, Brady E, Vsiansky V, Szabo JP, Dolezalova I, Fabo D, Pail M, Gutekunst CA, Migliore R, Migliore M, Lagarde S, Carron R, Karimi F, Astorga R, Cassara A, Kuster N, Neufeld E, Bartolomei F, Pedersen NP, Gross R, Jirsa V, Drane D, Brazdil M, Williamson A. Non-invasive Temporal Interference Stimulation of the Hippocampus Suppresses Epileptic Biomarkers in Patients with Epilepsy: Biophysical Differences between Kilohertz and Amplitude Modulated Stimulation. medRxiv [Preprint]. 2025 Jan 14:2024.12.05.24303799. doi: 10.1101/2024.12.05.24303799.
- Background: PubMed 37857775Violante IR, Alania K, Cassara AM, Neufeld E, Acerbo E, Carron R, Williamson A, Kurtin DL, Rhodes E, Hampshire A, Kuster N, Boyden ES, Pascual-Leone A, Grossman N. Non-invasive temporal interference electrical stimulation of the human hippocampus. Nat Neurosci. 2023 Nov;26(11):1994-2004. doi: 10.1038/s41593-023-01456-8. Epub 2023 Oct 19.
- Background: PubMed 28575667Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.
- Individual participant dataSharing planned: No
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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, MD / PD principal investigator
Duke University
Adam Williamson, PhD principal investigator
St. Anne's University Hospital, Brno Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi in people with Temporal Lobe Epilepsy (TLE) and Drug Resistant 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 5 inclusion and 8 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 16 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?
Contact Birgit Frauscher, MD, PhD (919-613-9386, birgit.frauscher@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07434986, which also lists 9 linked publications.
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 16 Oct 2026.