Lily's Grace Temporal Interference for Epilepsy
This study, called Lily's Grace Temporal Interference, is looking at a treatment called TES-TI (Transcranial Electrical Stimulation with Temporal Interference) for people with epilepsy. The goal is to see if TES-TI can improve sleep, reduce seizures, and help with emotional well-being. Researchers will measure changes in brain activity during sleep (NREM sleep slow-wave activity), the number of seizures you have each week, and your attention and reaction time (Psychomotor Vigilance Task). You might be able to join if you are 18 to 75 years old, speak English, and have epilepsy that hasn't responded well to other treatments, or if you experience cognitive decline. The study is currently unclear on its recruitment status.
- Study design
- This is a Phase I randomized, single-blind, cross-over feasibility study involving 16 participants with epilepsy. There are also 8 control participants for technical optimization.
- What's involved
- You would undergo an MRI, then complete four nights of TES-TI stimulation and four nights of sham stimulation (a treatment that feels like TES-TI but isn't active), separated by at least one day between visits. During each visit, you will complete questionnaires, have an HD-EEG (a test that measures brain waves) applied, and do an emotion regulation task.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your seizure frequency and attention will be tracked for up to 24 months, with follow-up appointments 1 and 3 months after completing both the TES-TI and sham conditions.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Lily's Grace Temporal Interference
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Melanie Boly, MD, PhD · PRINCIPAL_INVESTIGATOR · UW School of Medicine and Public Health
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- NREM Sleep Slow-Wave Activity Measured by High-Density EEG (delta power)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 weekdata 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)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)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)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 Correctmeasured 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 Timemeasured 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).