Sleep-Driven Adaptive Neuromodulation in Lennox-Gastaut Syndrome

Sleep-Driven Adaptive Neuromodulation in Lennox-Gastaut Syndrome

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

Inclusion Criteria:

• 18-65 years of age
• Diagnosis of Lennox-Gastaut Syndrome (LGS) with confirmed generalized seizures, including generalized tonic or tonic-clonic (GTC) seizures. Participants may also have complex partial, atypical absences or atonic seizures, but these will not count toward minimum seizure frequency eligibility.
• Diagnosis is based on prior video EEG confirmation performed in the last 3 years. Scalp EEG showing slow spike-wave discharges and paroxysmal fast activity.
• At least four seizures per month (GTC or tonic) on average during the three months preceding enrollment.
• Medically intractable epilepsy, defined as failure to achieve acceptable seizure control despite trials of at least two antiseizure medications (ASMs).
• Nonlocalized seizures, as determined by standard diagnostic studies.
• Stable doses of two or more ASMs for at least one month prior to enrollment (rescue benzodiazepines for acute seizure clusters permitted).
• Participants with vagus nerve stimulation (VNS) must have stable settings for at least two months prior to enrollment and throughout the study.
• Subjective reporting of sleep disturbances.
• Participant or legal guardian can provide informed consent and maintain an online seizure log, alone or with assistance.
• Participant is willing to remain on a stable ASM regimen (except use of variable dose of rescue medications permitted) throughout the study and able to attend scheduled clinic visits.
• Reliable caregiver is available to assist with seizure diary maintenance.

Exclusion Criteria:

• Predominant seizure type is focal-onset seizures.
• Anatomical brain abnormalities precluding DBS implantation, or discrete brain lesions on MRI (e.g., cortical malformation, tuber, or sclerosis).
• Unable to obtain brain MRI due to metal that is not compatible with 3T MRI.
• History of psychogenic non-epileptic seizures or unstable psychiatric disorders, including suicidal ideation or intent within the last six months.
• Clinically significant medical conditions increasing risk for pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
• Participant is pregnant or plans to become pregnant during the study.
• Participation in another therapeutic investigational drug or device study.
• Requirement for diathermy treatments during physical or occupational therapy.
• In the opinion of the investigator or eligibility adjudication committee, the subject is unsuitable for the procedure.