Overnight TI in TLE
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDuke University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi
DeviceNon-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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Single Group: Overnight TI Stimulation and Within-Subject No-Stimulation Control NightsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Night 1, no stimulation) and during active TI stimulation nights (average of Nights 2-4, overnight sleep period).Secondary outcomes
1
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.
Time frame
Night 1 (no stimulation), Nights 2-4 (active TI), and Night 5 (no stimulation), assessed over each overnight sleep period.2
PSG sleep outcomes - efficiency
Overnight polysomnography (PSG) measures of sleep stages and sleep quality/continuity. Higher sleep efficiency and lower fragmentation indicate improvement.
Time frame
Night 1 (no stimulation), Nights 2-4 (active TI), and Night 5 (no stimulation), assessed over each overnight sleep period.3
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.
Time frame
Night 1 (no stimulation), Nights 2-4 (active TI), and Night 5 (no stimulation), assessed over each overnight sleep period.4
PSG sleep outcomes - arousal index
Overnight polysomnography (PSG) measures of sleep stages and sleep quality/continuity. Higher sleep efficiency and lower fragmentation indicate improvement.
Time frame
Night 1 (no stimulation), Nights 2-4 (active TI), and Night 5 (no stimulation), assessed over each overnight sleep period.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
St. Anne's University Hospital Brno, Czech Republic
Collaborator
Source ClinicalTrials.gov
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