Overnight TI in TLE

N/ANot Yet RecruitingNCT07434986

Duke University20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Temporal Lobe Epilepsy (TLE)Drug Resistant Epilepsy

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Anphy Lab - Inside Hock Plaza

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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

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.

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.

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.

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.

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.

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

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

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

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

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)

Scores on validated anxiety and depression scales to assess changes in symptoms before versus after the stimulation block. Lower scores indicate fewer symptoms.

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)

Scores on validated anxiety and depression scales to assess changes in symptoms before versus after the stimulation block. Lower scores indicate fewer symptoms.

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)

Scores on validated anxiety and depression scales to assess changes in symptoms before versus after the stimulation block. Lower scores indicate fewer symptoms.

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

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

Time frame: During in-lab monitoring (Nights 1-5) and follow-up (Day 7)

Central Contacts

Matthew K Moye, BSc

CONTACT

919-668-9021 matthew.moye@duke.edu

Data from ClinicalTrials.gov

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