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NCT07434986 · ClinicalTrials.gov registry record · NA
Overnight TI in TLE
A NA study, sponsored by Duke University.
- Not yet
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT07434986: Clinical Trial NA study, sponsored by Duke University.
NCT07434986 is a NA study that has not yet begun recruiting, run by Duke University. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07434986, a NA study, has not yet begun recruiting, sponsored by Duke University.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- DEVICE Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2026-10-30 |
| Phase | NA |
What is known before NCT07434986 opens enrollment
NCT07434986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi is the first listed.
NCT07434986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07434986 about?
NCT07434986 is a clinical study titled "Overnight TI in TLE". 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 over...
What is the current status of trial NCT07434986?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2026-06-01. Estimated completion is 2026-10-30.
What interventions are being tested in trial NCT07434986?
The interventions under investigation include: Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi (DEVICE).
Who is sponsoring clinical trial NCT07434986?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07434986's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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