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
Qualifiers
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
Treatments tested in this trial
- Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Duke University
Lead sponsor
St. Anne's University Hospital Brno, Czech Republic
Collaborator
Source ClinicalTrials.gov