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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Personalized Adaptive Deep Brain Stimulation Therapy
DeviceThis 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.
Conventional Non-Personalized Deep Brain Stimulation Therapy
DeviceThe 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.
Treatment groups
4 Participants
are divided into 2 treatment groupsGroup A: Personalized aDBSExperimental treatment 1 intervention
Group B: cDBSActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in total tonic motor seizures between baseline (assessed by Caregiver reported seizures) and adaptive stimulation double-blinded study phase (assessed by Medtronic Percept PC system timeline data).
Caregiver reported seizures will provide baseline total tonic motor seizure count. Medtronic Percept PC system timeline data will provide adaptive stimulation double-blinded study phase total tonic motor seizure count. The total tonic motor seizure counts between baseline and the adaptive stimulation double-blinded study phase will be compared to see if there was a reduction from baseline.
Time frame
Total tonic seizure count at baseline are for the 3 months prior to invasive EEG investigation. Total tonic seizure count at adaptive stimulation double-blinded study phase is for 4 months.2
Change in total tonic motor seizures between baseline (assessed by Caregiver reported seizures) and adaptive stimulation double-blinded study phase (assessed by seizure detection watch data).
Caregiver reported seizures will provide baseline total tonic motor seizure count. Seizure detection watch data will provide adaptive stimulation double-blinded study phase total tonic motor seizure count. The total tonic motor seizure counts between baseline and the adaptive stimulation double-blinded study phase will be compared to see if there was a reduction from baseline.
Time frame
Total tonic seizure count at baseline are for the 3 months prior to invasive EEG investigation. Total tonic seizure count at adaptive stimulation double-blinded study phase is for 4 months.3
Change in total tonic-clonic motor seizures between baseline (assessed by Caregiver reported seizures) and adaptive stimulation double-blinded study phase (assessed by Medtronic Percept PC system timeline data).
Caregiver reported seizures will provide baseline total tonic-clonic motor seizure count. Medtronic Percept PC system timeline data will provide adaptive stimulation double-blinded study phase total tonic-clonic motor seizure count. The total tonic-clonic motor seizure counts between baseline and the adaptive stimulation double-blinded study phase will be compared to see if there was a reduction from baseline.
Time frame
Total tonic-clonic seizure count at baseline are for the 3 months prior to invasive EEG investigation. Total tonic-clonic seizure count at adaptive stimulation double-blinded study phase is for 4 months.4
Change in total tonic-clonic motor seizures between baseline (assessed by Caregiver reported seizures) and adaptive stimulation double-blinded study phase (assessed by seizure detection watch data).
Caregiver reported seizures will provide baseline total tonic-clonic motor seizure count. Seizure detection watch data will provide adaptive stimulation double-blinded study phase total tonic-clonic motor seizure count. The total tonic-clonic motor seizure counts between baseline and the adaptive stimulation double-blinded study phase will be compared to see if there was a reduction from baseline.
Time frame
Total tonic-clonic seizure count at baseline are for the 3 months prior to invasive EEG investigation. Total tonic-clonic seizure count at adaptive stimulation double-blinded study phase is for 4 months.Secondary outcomes
1
Participant sleep quality as assessed by Pittsburgh Sleep Quality Index questionnaire.
The minimum score is 0 and the maximum score is 21, with lower scores meaning better sleep quality.
Time frame
From the start date of baseline measurement until the end date of the double-blinded phase of the study, assessed up to 33 months.2
Participant quality of life as assessed by health-related, patient-centered Quality of Life in Neurological Disorders (Neuro-Qol) questionnaire
Participant quality of life will be assessed by five Neuro-Qol questionnaire domains, with raw scores from each domain converted into a T-score. Anxiety, Fatigue, Depression, Cognitive Function, Emotional and Behavioral Dyscontrol. A T-score of 50 represents the reference population mean, with a T-score of 60 being one standard deviation (SD) above the mean and a T-score of 40 being one SD below the mean. A higher T-score in the domains of Anxiety, Fatigue, Depression, Emotional and Behavioral Dyscontrol means worse outcomes than the reference population. A higher T-score in the Cognitive Function means better outcomes than the reference population.
Time frame
From the start date of baseline measurement until the end date of the double-blinded phase of the study, assessed up to 33 months.3
Participant quality of life as assessed by Patient-Reported Outcomes Measurement Information System-Profile 57 (PROMIS-57) version 2.1
PROMIS-57 measures quality of life across seven domains, with raw scores from each domain converted into a T-score. A T-score of 50 represents the reference population mean, with a T-score of 60 being one standard deviation (SD) above the mean and a T-score of 40 being one SD below the mean. A higher T-score in the domains of fatigue, anxiety, pain interference, pain intensity, and sleep disturbance means worse outcomes than the reference population. A higher T-score in the domains of physical function and ability to participate in social roles and activities means better outcomes than the reference population.
Time frame
From the start date of baseline measurement until the end date of the double-blinded phase of the study, assessed up to 33 months.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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