TES-TI for Epilepsy

(SLEEP-TIES Trial)

Overseen By Beril Mat, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Neurological disorders, Headaches, Systemic illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 8 nights

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Melanie Boly, MD, PhD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

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

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

How Is the Trial Designed?

Group I: Sham Stimulation then Real Stimulation Experimental Treatment 3 Interventions

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

Group II: Real Stimulation then Sham Stimulation Experimental Treatment 3 Interventions

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

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