La Gracia Temporal de Interferencia de Lily (SLEEP-TIES)
Uso de interferencia temporal para mejorar de forma no invasiva la homeostasis del sueño en pacientes con epilepsia
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Melanie Boly, MD, PhD
- Número de teléfono: 608-263-4338
- Correo electrónico: boly@neurology.wisc.edu
Copia de seguridad de contactos de estudio
- Nombre: Beril Mat, MD
- Correo electrónico: mat@wisc.edu
Ubicaciones de estudio
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- UW School of Medicine and Public Health
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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.
Otros nombres:
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Experimental: 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.
Otros nombres:
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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NREM Sleep Slow-Wave Activity Measured by High-Density EEG (delta power)
Periodo de tiempo: measured during 8 overnight visits, data collected up to 24 months on study
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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
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Number of Seizures per week
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
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|
Stanford Sleepiness Scale (SSS)
Periodo de tiempo: 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
Periodo de tiempo: measured during 8 overnight visits, data collected up to 24 months on study
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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
|
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Emotional Processing Task (Face Task): Percent Change in Reaction Time
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Melanie Boly, MD, PhD, UW School of Medicine and Public Health
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Epilepsia
- Convulsiones
- Terapéutica
- Disciplinas y actividades de comportamiento
- Terapia de estimulación eléctrica
- Terapia convulsiva
- Terapias somáticas psiquiátricas
- Electrochoque
- Técnicas psicológicas
- Estimulación de corriente continua transcraneal
Otros números de identificación del estudio
- 2025-1852
- SMPH | NRL Neurology (Otro identificador: UW Madison)
- Protocol Version 2/17/26 (Otro identificador: UW Madison)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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