Lily's Grace Temporal Interference

Официальное название

Using Temporal Interference to Non-Invasively Enhance Sleep Homeostasis in Patients With Epilepsy

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство TES-TI
  Real stimulation will take place on visits 2 - 5 or visits 6 - 10.
• Другое Sham Stimulation
  Sham stimulation will take place on visits 2 - 5 or visits 6 - 10.
• Другое Structural and Functional MRI
  After baseline night visit 1 and before intervention visits 2 - 10. MRI is used to help determine electrode placement.

Первичные конечные точки

• NREM Sleep Slow-Wave Activity Measured by High-Density EEG (delta power) [Срок оценки: measured during 8 overnight visits, data collected up to 24 months on study]
• Number of Seizures per week [Срок оценки: 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) [Срок оценки: measured during 8 overnight visits, data collected up to 24 months on study]
• Restorative Sleep Questionnaire (REST-Q) [Срок оценки: measured during 8 overnight visits, data collected up to 24 months on study]
• Stanford Sleepiness Scale (SSS) [Срок оценки: measured during 8 overnight visits, data collected up to 24 months on study]
• Emotional Processing Task (Face Task): Percent Correct [Срок оценки: measured during 8 overnight visits, data collected up to 24 months on study]
• Emotional Processing Task (Face Task): Percent Change in Reaction Time [Срок оценки: measured during 8 overnight visits, data collected up to 24 months on study]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UW School of Medicine and Public Health — Madison

Идентификаторы

NCT: NCT07520955 · 2025-1852 · SMPH | NRL Neurology · Protocol Version 2/17/26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗