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NOT YET RECRUITING
NCT07568860
NA

Sleep-Driven Adaptive Neuromodulation in Lennox-Gastaut Syndrome

Sponsor: University of Minnesota

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to explore a new type of personalized brain stimulation that works during day time and night time hours using the Medtronic Percept Deep Brain Stimulation (DBS) device in patients with Lennox-Gastaut Syndrome. The main question(s) this study aims to answer is: 1. Does using the personalized DBS reduce motor seizures compared to conventional DBS? 2. Is the number of seizures reported by caregivers different for patients using the personalized DBS? 3. How often do patients using the personalized DBS experience undesired side effects? Researchers will compare the personalized DBS that works night time, personalized DBS device that works during the day time, and conventional DBS. Participants will: 1. Have their seizures and sleep patterns recorded for 3-months 2. Assess their neurocognitive function 3. Answer questionnaires about communication, movement, and sleep quality 4. Wear a sleep headband and seizure warning watch for 5 nights 5. Complete a mood and sleep assessment 6. Have a 3T and possibly 7T MRI 7. Be implanted with stereo-encephalography and undergo 3\~5 days of monitoring 8. Have the stereo-encephalography taken out 9. Receive DBS implantation through surgery and have several months of stimulation and no stimulation periods 10. Have routine clinical visits to check on healing after surgery 11. Have their caregiver help them keep a dairy about their seizures, sleep and quality of life

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

4

Start Date

2026-10-01

Completion Date

2031-09-30

Last Updated

2026-05-06

Healthy Volunteers

No

Interventions

DEVICE

Personalized Adaptive Deep Brain Stimulation Therapy

This approach employs Bayesian optimized individualized stimulation parameters tailored to each patient. For 12 daytime hours (e.g., 8 AM-8 PM, adjustable per patient but fixed within each subject), the device will operate in continuous cycling mode delivering the optimized stimulation parameter (i.e patient specific frequency, pulse width, amplitude). The device will be programmed for AM and PM mode (e.g., 8AM-8 PM= AM mode; PM mode=8 PM-8 AM), the device will switched to adaptive mode manually by the caregiver, dynamically adjusting only the stimulation amplitude in response to real-time brain activity.

DEVICE

Conventional Non-Personalized Deep Brain Stimulation Therapy

The device will deliver conventional non-personalized stimulation parameters (145 Hz, 90 microsec, fixed current amplitude, 1 Min ON, 5 mins OFF) throughout both daytime and nighttime periods.