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SLEEP-TIESNCT07520955

Lily's Grace Temporal Interference

StatusNot Yet Recruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 4 months later.

See at-risk trials from University of Wisconsin, Madison

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Record History

All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗

  1. Start date pushed from Oct 2026 to Nov 2026
  2. Start date: Sep 2026 to Oct 2026
    • Eligibility criteria expanded, about 15 words
    • Collaborators: details revised at 1 of 1 entry
    • Study description expanded, about 5 words
  3. Primary and study completion pushed from Apr 2028 to Sep 2028
    • Start date: Aug 2026 to Sep 2026
    v6
  4. Start date: Jul 2026 to Aug 2026v5
  5. Start date: Jun 2026 to Jul 2026v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: May 2026 to Jun 2026v3
  2. Start date: Apr 2026 to May 2026v2
  1. Study First Submitted
  • Minor: routine updates

Endpoints

Primary

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

Arms and interventions

Sham Stimulation then Real StimulationExperimental

Each participant will undergo structural and functional MRI then eight nights of intervention with possible sham or non-sham stimulation conditions.

Real Stimulation then Sham StimulationExperimental

Each participant will undergo structural and functional MRI then eight nights of intervention with possible sham or non-sham stimulation conditions.

Devices: TES-TI

Other: Sham Stimulation, Structural and Functional MRI

Sites

1 site in 1 country

  • UW School of Medicine and Public HealthMadison, Wisconsin, United States