リリーの優雅な時間干渉 (SLEEP-TIES)
てんかん患者における睡眠恒常性を非侵襲的に向上させるための時間的干渉の利用
This study is to evaluate the effectiveness of targeted Transcranial Electrical Stimulation with Temporal Interference (TES-TI) interventions to boost Non-Rapid Eye Movement (NREM) sleep, decrease seizures and promote emotional health in patients with epilepsy. Up to 24 participants (8 control participants for technical optimization prior to recruitment and 16 patients with epilepsy) will be enrolled and can expect to be on study for up to 24 months.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
This is a Phase I randomized, single-blind, cross-over feasibility study comprised of 16 participants. Each participant will undergo structural and functional MRI then complete four nights of TES-TI stimulation and four nights of sham stimulation in counterbalanced order, separated by ≥1 day between visits.
Conditions on each visit are randomized and counterbalanced. During each visit, participants will complete both the REST-Q and SSS questionnaires. Full HD-EEG will be applied as well as 4-16 stimulation electrodes. Participants will then undergo an emotion regulation task (face task) wherein they are presented with positive, negative, or neutral emotional stimuli.
This is followed by a resting HD-EEG recording, then overnight stimulation. Either sham or non-sham (8 patients in each group) stimuli will be applied at times during the sleep period. Upon waking, the same questionnaires and emotion regulation tasks will be completed.
Objectives:
- Assess the efficacy of TES-TI to boost sleep NREM slow-wave activity and spindles in patients with epilepsy overnight
- Assess the efficacy of TES-TI to improve sleep quality and mood (REST-Q) and sleepiness (sleepiness scale) after treatment (4 nights) vs. before
- Assess the efficacy of TES-TI to improve emotion responses (face task) and vigilance (psychomotor vigilance task; PVT) after treatment (4 nights) vs. before
- Assess the efficacy of TES-TI to improve restorative quality of sleep (REST-Q questionnaire) after treatment (4 nights) vs. before
- Assess the efficacy of TES-TI to reduce seizure frequency (self-reported) after treatment (4 nights) vs. before
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Melanie Boly, MD, PhD
- 電話番号：608-263-4338
- メール：boly@neurology.wisc.edu
研究連絡先のバックアップ
- 名前：Beril Mat, MD
- メール：mat@wisc.edu
研究場所
-
-
Wisconsin
-
Madison、Wisconsin、アメリカ、53792
- UW School of Medicine and Public Health
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- English-speaking (able to provide consent and complete questionnaires)
- Citizen or holding permanent resident status
- History of refractory epilepsy with intractable seizures and/or cognitive decline
Exclusion Criteria:
- Any current or past history of neurological disorders or acquired neurological disease other than epilepsy (e.g. stroke, traumatic brain injury), including intracranial lesions
- Current history of poorly controlled headaches including intractable or poorly controlled migraines
- Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- Possible pregnancy or plan to become pregnant in the next 6 months
- Any metal in the head
- Any metal in the body
- Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
- Dental implants
- Permanent retainers
- Claustrophobia (a fear of small or closed places)
- Back problems that would prevent lying flat for several hours
- Regular night-shift work (second or third shift)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Sham Stimulation then Real Stimulation
Each participant will undergo structural and functional MRI then eight nights of intervention with possible sham or non-sham stimulation conditions. |
Real stimulation will take place on visits 2 - 5 or visits 6 - 10.
他の名前：
Sham stimulation will take place on visits 2 - 5 or visits 6 - 10. After baseline night visit 1 and before intervention visits 2 - 10. MRI is used to help determine electrode placement.
他の名前：
|
|
実験的：Real Stimulation then Sham Stimulation
Each participant will undergo structural and functional MRI then eight nights of intervention with possible sham or non-sham stimulation conditions. |
Real stimulation will take place on visits 2 - 5 or visits 6 - 10.
他の名前：
Sham stimulation will take place on visits 2 - 5 or visits 6 - 10. After baseline night visit 1 and before intervention visits 2 - 10. MRI is used to help determine electrode placement.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
NREM Sleep Slow-Wave Activity Measured by High-Density EEG (delta power)
時間枠：measured during 8 overnight visits, data collected up to 24 months on study
|
To assess the effect of TES-TI on NREM sleep slow-wave activity during treatment (4 nights) vs. sham (4 nights), slow-wave activity will be measured by high-density EEG. |
measured during 8 overnight visits, data collected up to 24 months on study
|
|
Number of Seizures per week
時間枠：data collected at 4 time points up to 24 months on study, 1 month and 3 month follow up after completion of 4 nights treatment and 1 month and 3 month follow up after completion 4 nights sham condition
|
To assess the effect of TES-TI on incidence of seizures after treatment (4 nights) vs. sham (4 nights), participants will maintain a seizure diary. The self-reported number of seizures seizures per week for the first week and the first four-weeks post-intervention. |
data collected at 4 time points up to 24 months on study, 1 month and 3 month follow up after completion of 4 nights treatment and 1 month and 3 month follow up after completion 4 nights sham condition
|
|
Psychomotor Vigilance Task (PVT)
時間枠：measured during 8 overnight visits, data collected up to 24 months on study
|
The vigilance task will be used to assess the effect of TES-TI on performance after treatment (4 nights) vs. sham (4 nights). This is a computerized reaction time task where a participant is presented with a fixation point on a computer screen. At random, the fixation point will change appearance at which point the participant is to click a provided button as quickly as possible. The time it took to respond is recorded automatically by the computer program and will be reported as the result. |
measured during 8 overnight visits, data collected up to 24 months on study
|
|
Restorative Sleep Questionnaire (REST-Q)
時間枠：measured during 8 overnight visits, data collected up to 24 months on study
|
The REST-Q measure will be used to assess the effect of TES-TI on sleep quality and mood after treatment (4 nights) vs. sham (4 nights). It is a 9-item questionnaire assessing aspects of restorative sleep. Each item is scored on a 5-point Likert scale (1-light; 5-deep). Final scores are transformed to a scale of 0-100 here higher scores indicate more restorative sleep. |
measured during 8 overnight visits, data collected up to 24 months on study
|
|
Stanford Sleepiness Scale (SSS)
時間枠：measured during 8 overnight visits, data collected up to 24 months on study
|
The Stanford Sleepiness Scale will be used to assess sleepiness after treatment (4 nights) vs. sham (4 nights). SSS is a measure of subjective alertness on a 7-point scale (total range of scores from 1-7). A lower score on the scale indicates higher alertness. |
measured during 8 overnight visits, data collected up to 24 months on study
|
|
Emotional Processing Task (Face Task): Percent Correct
時間枠：measured during 8 overnight visits, data collected up to 24 months on study
|
The Face Task will be used to assess the effect of TES-TI on emotion response after treatment (4 nights) vs. sham (4 nights). This task involves viewing a series of emotionally charged images (60 positive, 60 negative, 60 neutral). |
measured during 8 overnight visits, data collected up to 24 months on study
|
|
Emotional Processing Task (Face Task): Percent Change in Reaction Time
時間枠：measured during 8 overnight visits, data collected up to 24 months on study
|
The Face Task will be used to assess the effect of TES-TI on emotion response after treatment (4 nights) vs. sham (4 nights). This task involves viewing a series of emotionally charged images (60 positive, 60 negative, 60 neutral). |
measured during 8 overnight visits, data collected up to 24 months on study
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Melanie Boly, MD, PhD、UW School of Medicine and Public Health
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 2025-1852
- SMPH | NRL Neurology (その他の識別子：UW Madison)
- Protocol Version 2/17/26 (その他の識別子：UW Madison)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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