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Lilys Grace Temporal Interferens (SLEEP-TIES)

28. oktober 2026 oppdatert av: University of Wisconsin, Madison

Bruke Temporal Interferens for Å Forbedre Søvn Homeostase Ikke-invasivt Hos Pasienter Med Epilepsi

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Antatt)

24

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • UW School of Medicine and Public Health

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: TES-TI

Real stimulation will take place on visits 2 - 5 or visits 6 - 10.

Andre navn:
  • Transkraniell elektrisk stimulering med temporær interferens
Annen: Sham Stimulation

Sham stimulation will take place on visits 2 - 5 or visits 6 - 10.

Annen: Structural and Functional MRI

After baseline night visit 1 and before intervention visits 2 - 10. MRI is used to help determine electrode placement.

Andre navn:
  • EEG-fMR
  • anatomisk MR
Eksperimentell: 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.
Enhet: TES-TI

Real stimulation will take place on visits 2 - 5 or visits 6 - 10.

Andre navn:
  • Transkraniell elektrisk stimulering med temporær interferens
Annen: Sham Stimulation

Sham stimulation will take place on visits 2 - 5 or visits 6 - 10.

Annen: Structural and Functional MRI

After baseline night visit 1 and before intervention visits 2 - 10. MRI is used to help determine electrode placement.

Andre navn:
  • EEG-fMR
  • anatomisk MR

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
NREM Sleep Slow-Wave Activity Measured by High-Density EEG (delta power)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Wisconsin, Madison

Samarbeidspartnere

Lily's Fund for Epilepsy Research

Etterforskere

  • Hovedetterforsker: Melanie Boly, MD, PhD, UW School of Medicine and Public Health

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. september 2028

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

2. april 2026

Først innsendt som oppfylte QC-kriteriene

2. april 2026

Først lagt ut (Faktiske)

9. april 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. oktober 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-1852
  • SMPH | NRL Neurology (Annen identifikator: UW Madison)
  • Protocol Version 2/17/26 (Annen identifikator: UW Madison)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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