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治験 NCT07434986 (TI-HPC-TLE)（対象：Temporal Lobe Epilepsy (TLE)、薬剤耐性てんかん、睡眠）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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デューク大学Overnight TI in TLE (TI-HPC-TLE) 20 非侵襲
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07434986 (TI-HPC-TLE) は 介入研究 臨床試験 で、Temporal Lobe Epilepsy (TLE)、薬剤耐性てんかん、睡眠 に関するものです。現在は 募集準備中 で、2026年5月1日 に開始予定です。20 名の参加者 の募集が計画されています。この試験は デューク大学 によって主導され、2026年6月15日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月18日 です。
概要
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 quali...
もっと見る公式タイトル
Overnight Temporal Interference Stimulation of Bilateral Hippocampi to Reduce Epileptogenic Biomarkers and Improve Sleep in Temporal Lobe Epilepsy
疾患名
Temporal Lobe Epilepsy (TLE)薬剤耐性てんかん睡眠刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- TI-HPC-TLE
- Pro00119826
NCT番号
開始日
2026-05-01
最終更新日
2026-03-18
終了予定日
2026-06-15
目標参加者数
20
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
Epilepsy
Temporal Lobe
Epilepsy and Sleep
Drug Resistant Epilepsy
Temporal Interference
Stimulation
Hippocampus
Sleep
Temporal Lobe
Epilepsy and Sleep
Drug Resistant Epilepsy
Temporal Interference
Stimulation
Hippocampus
Sleep
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的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, ...もっと見る | Non-invasive Temporal Interference (TI) Stimulation Targeting Bilateral Hippocampi 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 gradu...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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. | Baseline (Night 1, no stimulation) and during active TI stimulation nights (average of Nights 2-4, overnight sleep period). |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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. | 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. | 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. | 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. | 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. | 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 | 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 | 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. | 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. | 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. | 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 | During in-lab monitoring (Nights 1-5) and follow-up (Day 7) |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- 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
- 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
デューク大学St. Anne's University Hospital Brno, Czech Republic試験中央連絡先
連絡先: Matthew K Moye, BSc, 919-668-9021, [email protected]
1 1カ国の場所
North Carolina
Anphy Lab - Inside Hock Plaza, Durham, North Carolina, 27705, United States
Matthew K Moye, BSc, 連絡先, 919-668-9021, [email protected]