An interventional study of TES-TI and Sham Stimulation in Epilepsy, sponsored by University of Wisconsin, Madison. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
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.
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:
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's planned enrollment of 24 is below the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant will undergo structural and functional MRI then eight nights of intervention with possible sham or non-sham stimulation conditions.
Device: TES-TI · Other: Sham Stimulation · Other: Structural and Functional MRI
Each participant will undergo structural and functional MRI then eight nights of intervention with possible sham or non-sham stimulation conditions.
Device: TES-TI · Other: Sham Stimulation · Other: Structural and Functional MRI
Real stimulation will take place on visits 2 - 5 or visits 6 - 10.
Also known as: Transcranial Electrical Stimulation with Temporal Interference
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.
Also known as: EEG-fMRI, anatomic MRI
NREM Sleep Slow-Wave Activity Measured by High-Density EEG (delta power)
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.
Time frame: measured during 8 overnight visits, data collected up to 24 months on study
Number of Seizures per week
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.
Time frame: 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)
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.
Time frame: measured during 8 overnight visits, data collected up to 24 months on study
Restorative Sleep Questionnaire (REST-Q)
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.
Time frame: measured during 8 overnight visits, data collected up to 24 months on study
Stanford Sleepiness Scale (SSS)
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.
Time frame: measured during 8 overnight visits, data collected up to 24 months on study
Emotional Processing Task (Face Task): Percent Correct
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).
Time frame: measured during 8 overnight visits, data collected up to 24 months on study
Emotional Processing Task (Face Task): Percent Change in Reaction Time
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).
Time frame: measured during 8 overnight visits, data collected up to 24 months on study
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Wisconsin, Madison →