릴리의 은혜 시간 간섭 (SLEEP-TIES)
시간적 간섭을 이용하여 간질 환자의 수면 항상성 비침습적으로 강화하기
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.
연구 개요
상세 설명
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
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Melanie Boly, MD, PhD
- 전화번호: 608-263-4338
- 이메일: boly@neurology.wisc.edu
연구 연락처 백업
- 이름: Beril Mat, MD
- 이메일: mat@wisc.edu
연구 장소
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- UW School of Medicine and Public Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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NREM Sleep Slow-Wave Activity Measured by High-Density EEG (delta power)
기간: 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
기간: 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
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Psychomotor Vigilance Task (PVT)
기간: measured during 8 overnight visits, data collected up to 24 months on study
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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
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|
Restorative Sleep Questionnaire (REST-Q)
기간: measured during 8 overnight visits, data collected up to 24 months on study
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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)
기간: measured during 8 overnight visits, data collected up to 24 months on study
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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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Melanie Boly, MD, PhD, UW School of Medicine and Public Health
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025-1852
- SMPH | NRL Neurology (기타 식별자: UW Madison)
- Protocol Version 2/17/26 (기타 식별자: UW Madison)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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