TES-TI for Epilepsy

(SLEEP-TIES Trial)

MB
BM
Overseen ByBeril Mat, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called TES-TI, which uses electrical stimulation to enhance deep sleep, reduce seizures, and support emotional health in people with epilepsy. Participants will be divided into two groups: one will receive real stimulation first, followed by a placebo version, while the other group will experience the reverse order. Individuals with epilepsy and frequent seizures that do not respond well to treatment may be suitable candidates. Participants must speak English, be a citizen or permanent resident, and not have other neurological disorders or certain medical devices.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve epilepsy treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that TES-TI is safe for epilepsy patients?

Previous studies have shown that transcranial electrical stimulation with temporal interference (TES-TI) is safe and well-tolerated. Research indicates that this method does not cause significant harm to the brain or nervous system. Specifically, one study found that TES-TI is safe for both brain and mental functions.

Furthermore, TES-TI has been tested in people without causing major side effects. Any side effects are expected to resemble those seen with other types of transcranial electric current stimulation, which are generally mild. This suggests that TES-TI is a safe option for people with epilepsy seeking new treatments in clinical trials.12345

Why are researchers excited about this trial?

TES-TI is unique because it uses a non-invasive method called transcranial electrical stimulation to potentially manage epilepsy. Unlike traditional options like anti-seizure medications, which can have systemic side effects, TES-TI directly targets brain activity by delivering mild electrical currents to the scalp, potentially offering a safer alternative with fewer side effects. Researchers are excited about TES-TI because it offers a novel approach to altering brain function without the need for surgery or medication, and it could provide a new avenue for treatment, especially for those who do not respond well to current therapies.

What evidence suggests that TES-TI is effective for epilepsy?

Research has shown that Transcranial Electrical Stimulation with Temporal Interference (TES-TI) might help reduce epilepsy symptoms. Studies have found that TES-TI can significantly lower abnormal brain activities between seizures. This suggests that TES-TI might reduce seizure frequency or severity. Additionally, research indicates that TES-TI can reach deep brain areas without surgery, potentially easing epilepsy symptoms. Although more research is needed, these early findings are promising and suggest that TES-TI could benefit people with epilepsy. Participants in this trial will experience both real and sham stimulation to evaluate TES-TI's effectiveness.14678

Who Is on the Research Team?

MB

Melanie Boly, MD, PhD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with epilepsy who have ongoing seizures or memory problems that don't improve with treatment. Participants must be citizens or permanent residents and cannot join if they have metal in their body, certain implants, are pregnant, work night shifts, have other brain disorders besides epilepsy, severe headaches, or serious medical conditions.

Inclusion Criteria

Citizen or holding permanent resident status
English-speaking (able to provide consent and complete questionnaires)
I have epilepsy that does not respond to treatment and causes ongoing seizures or memory problems.

Exclusion Criteria

Any metal in the head
Any metal in the body
Dental implants
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo structural and functional MRI and complete baseline questionnaires

1 week
1 visit (in-person)

Treatment

Participants receive TES-TI stimulation and sham stimulation over eight nights in a cross-over design

8 nights
8 overnight visits (in-person)

Follow-up

Participants are monitored for seizure frequency and sleep quality post-treatment

3 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • TES-TI

Trial Overview

The study tests a new type of non-invasive brain stimulation called TES-TI to see if it can improve sleep quality and reduce seizures in people with epilepsy. Some participants will receive real stimulation while others get sham (fake) stimulation as a comparison. MRI scans are also used to monitor changes.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Sham Stimulation then Real StimulationExperimental Treatment3 Interventions
Group II: Real Stimulation then Sham StimulationExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Lily's Fund for Epilepsy Research

Collaborator

Citations

Transcranial current stimulation in epilepsy: A systematic ...

Studying clinical outcomes, one of the main techniques to quantitatively measure the benefit of tES in epileptic patients is focusing on change ...

TES-TI for Epilepsy · Info for Participants · Clinical Trial 2026

This study is to evaluate the effectiveness of targeted Transcranial Electrical Stimulation with Temporal Interference (TES-TI) ...

Insights from bilateral temporal lobe and posterior epilepsy ...

Hip-DBS reduces seizures by 77.8 % (disabling) and 47.9 % (non-disabling). •. Long-term follow-up shows 86.7 % responder rate for disabling seizures. •.

Non-invasive temporal interference stimulation of the ...

Our results demonstrate that TI stimulation significantly decreases interictal epileptiform discharges (IEDs) and pathological high-frequency oscillations (HFOs) ...

Rates and Predictors of Seizure Freedom With Vagus ...

Specifically, 49% of patients responded to VNS at 0 to 4 months after implantation, with 5.1% of patients becoming seizure-free (median seizure reduction = 47%) ...

Low intensity transcranial electric stimulation: Safety, ethical ...

This guideline summarizes updated safety data (2017–2025) and provides expert recommendations on the use of low intensity transcranial electrical ...

Safety Evaluation of Employing Temporal Interference ...

These results support that TI-tACS is safe and tolerable in terms of neurological and neuropsychological functions and adverse effects for use in human brain ...

Safety Recommendations for Temporal Interference ...

Based on the results of our simulations and existing knowledge regarding tES and DBS safety, we propose frequency-dependent thresholds below ...