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Clinical Trial NCT07434986 (TI-HPC-TLE) for Temporal Lobe Epilepsy (TLE), Drug Resistant Epilepsy, Sleep is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Duke UniversityOvernight TI in TLE (TI-HPC-TLE) 20 Non-Invasive
Clinical Trial NCT07434986 (TI-HPC-TLE) is an interventional study for Temporal Lobe Epilepsy (TLE), Drug Resistant Epilepsy, Sleep and is currently not yet recruiting. Enrollment is planned to begin on 1 May 2026 and continue until the study accrues 20 participants. Led by Duke University, this study is expected to complete by 15 June 2026. The latest data from ClinicalTrials.gov was last updated on 18 March 2026.
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 quali...
Show MoreOfficial Title
Overnight Temporal Interference Stimulation of Bilateral Hippocampi to Reduce Epileptogenic Biomarkers and Improve Sleep in Temporal Lobe Epilepsy
Conditions
Temporal Lobe Epilepsy (TLE)Drug Resistant EpilepsySleepPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- TI-HPC-TLE
- Pro00119826
NCT ID Number
Start Date (Actual)
2026-05-01
Last Update Posted
2026-03-18
Completion Date (Estimated)
2026-06-15
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Epilepsy
Temporal Lobe
Epilepsy and Sleep
Drug Resistant Epilepsy
Temporal Interference
Stimulation
Hippocampus
Sleep
Temporal Lobe
Epilepsy and Sleep
Drug Resistant Epilepsy
Temporal Interference
Stimulation
Hippocampus
Sleep
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSingle 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, ...Show More | 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 gradu...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Baseline (Night 1, no stimulation) and during active TI stimulation nights (average of Nights 2-4, overnight sleep period). |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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. | 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. | 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. | 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 | 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 | 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. | 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. | 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. | 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 | During in-lab monitoring (Nights 1-5) and follow-up (Day 7) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Duke UniversitySt. Anne's University Hospital Brno, Czech RepublicStudy Central Contact
Contact: Matthew K Moye, BSc, 919-668-9021, [email protected]
1 Study Locations in 1 Countries
North Carolina
Anphy Lab - Inside Hock Plaza, Durham, North Carolina, 27705, United States
Matthew K Moye, BSc, Contact, 919-668-9021, [email protected]