Lily's Grace Temporal Interference
NCT07520955 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-05-01
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
Interventions
- DEVICE
-
TES-TI
Real stimulation will take place on visits 2 - 5 or visits 6 - 10.
- OTHER
-
Sham Stimulation
Sham stimulation will take place on visits 2 - 5 or visits 6 - 10.
- OTHER
-
Structural and Functional MRI
After baseline night visit 1 and before intervention visits 2 - 10. MRI is used to help determine electrode placement.
Sponsors & Collaborators
-
Lily's Fund for Epilepsy Research
collaborator UNKNOWN -
University of Wisconsin, Madison
lead OTHER
Principal Investigators
-
Melanie Boly, MD, PhD · UW School of Medicine and Public Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2028-04-30
- Completion
- 2028-04-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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