Overnight Temporal Interference Stimulation of Bilateral Hippocampi to Reduce Epileptogenic Biomarkers and Improve Sleep in Temporal Lobe Epilepsy
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Overnight Interictal Epileptiform Discharge (IED) Rate on Scalp EEG
概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Single 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, with safety/tolerability monitoring and pre/post cognitive and mood assessments.
干预措施: Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi (Device)
结局指标
主要结局
Change in Overnight Interictal Epileptiform Discharge (IED) Rate on Scalp EEG
时间窗: Baseline (Night 1, no stimulation) and during active TI stimulation nights (average of Nights 2-4, overnight sleep period).
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.
次要结局
- PSG sleep outcomes - time in REM (rapid eye movement)(Night 1 (no stimulation), Nights 2-4 (active TI), and Night 5 (no stimulation), assessed over each overnight sleep period.)
- PSG sleep outcomes - efficiency(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(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(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(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(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(Pre-stimulation (baseline, prior to Night 2) and post-stimulation (after Night 4 or on Day 6))
- Psychiatric symptom measures - Beck Anxiety Inventory (BAI)(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)(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)(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(During in-lab monitoring (Nights 1-5) and follow-up (Day 7))