Lily's Grace Temporal Interference

NCT07520955 | Not Yet Recruiting FDA Device

• 3 other identifiers: 2025-1852SMPH | NRL NeurologyProtocol Version 2/17/26
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy

Keywords

seizures; non rapid eye movement sleep

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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).

  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).

  measured during 8 overnight visits, data collected up to 24 months on study

Study Arms (2)

Sham Stimulation then Real Stimulation

EXPERIMENTAL

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 then Sham Stimulation

EXPERIMENTAL

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

Interventions

TES-TI DEVICE

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

Also known as: Transcranial Electrical Stimulation with Temporal Interference

Real Stimulation then Sham Stimulation; Sham Stimulation then Real Stimulation

Sham Stimulation OTHER

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

Real Stimulation then Sham Stimulation; Sham Stimulation then Real Stimulation

Structural and Functional MRI OTHER

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

Real Stimulation then Sham Stimulation; Sham Stimulation then Real Stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Lily's Fund for Epilepsy Research: collaborator

Study Sites (1)

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Melanie Boly, MD, PhD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Boly, MD, PhD

CONTACT

608-263-4338; boly@neurology.wisc.edu

Beril Mat, MD

CONTACT

mat@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)