Using Temporal Interference to Non-Invasively Enhance Sleep Homeostasis in Patients With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- NREM Sleep Slow-Wave Activity Measured by High-Density EEG (delta power)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: TES-TI (Device)
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.
干预措施: Structural and Functional MRI (Other)
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.
干预措施: Structural and Functional MRI (Other)
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.
干预措施: TES-TI (Device)
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.
干预措施: Sham Stimulation (Other)
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.
干预措施: Sham Stimulation (Other)
结局指标
主要结局
NREM Sleep Slow-Wave Activity Measured by High-Density EEG (delta power)
时间窗: 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.
Number of Seizures per week
时间窗: 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.
Psychomotor Vigilance Task (PVT)
时间窗: 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.
Restorative Sleep Questionnaire (REST-Q)
时间窗: 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.
Stanford Sleepiness Scale (SSS)
时间窗: 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.
Emotional Processing Task (Face Task): Percent Correct
时间窗: 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).
Emotional Processing Task (Face Task): Percent Change in Reaction Time
时间窗: 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).
次要结局
未报告次要终点