Sleep-Driven Adaptive Neuromodulation in Lennox-Gastaut Syndrome

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

Conditions

• Lennox Gastaut Syndrome (LGS)
• Epilepsy

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.

Sponsors & Collaborators

• University of Minnesota

  lead OTHER

Principal Investigators

• Sandipan Pati, MBBS · University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-01

Primary Completion

2030-09-30

Completion

2031-09-30

FDA Device

Yes