Sleep-Driven Adaptive Neuromodulation in Lennox-Gastaut Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Minnesota
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Personalized Adaptive Deep Brain Stimulation Therapy
- Conventional Non-Personalized Deep Brain Stimulation Therapy
Treatment groups
4 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov