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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:
Researchers will compare the personalized DBS that works night time, personalized DBS device that works during the day time, and conventional DBS.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized aDBS | Experimental | Participants will receive the Personalized Adaptive DBS Therapy. |
|
| cDBS | Active Comparator | Participants will receive the Conventional Non-Personalized DBS Therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Adaptive Deep Brain Stimulation Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start date of baseline measurement until the end date of the double-blinded phase of the study, assessed up to 33 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Hansen | Contact | 763-807-1858 | hans5057@umn.edu | |
| Monica Bondy | Contact | bondy023@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sandipan Pati, MBBS | University of Minnesota | Principal Investigator |
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De-identified data may be shared for future use.
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| ID | Term |
|---|---|
| D065768 | Lennox Gastaut Syndrome |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D000073376 | Epileptic Syndromes |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Conventional Non-Personalized Deep Brain Stimulation Therapy | Device | 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. |
|
| 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. | 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. |
| Change in total tonic motor seizures between baseline (assessed by Caregiver reported seizures) and continuous 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 continuous stimulation double-blinded study phase total tonic motor seizure count. The total tonic motor seizure counts between baseline and the continuous stimulation double-blinded study phase will be compared to see if there was a reduction from baseline. | Total tonic seizure count at baseline are for the 3 months prior to invasive EEG investigation. Total tonic seizure count at continuous stimulation double-blinded study phase is for 4 months. |
| Change in total tonic motor seizures between baseline (assessed by Caregiver reported seizures) and continuous 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 continuous stimulation double-blinded study phase total tonic motor seizure count. The total tonic motor seizure counts between baseline and the continuous stimulation double-blinded study phase will be compared to see if there was a reduction from baseline. | Total tonic seizure count at baseline are for the 3 months prior to invasive EEG investigation. Total tonic seizure count at continuous stimulation double-blinded study phase is for 4 months. |
| Change in total tonic-clonic motor seizures between baseline (assessed by Caregiver reported seizures) and continuous 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 continuous stimulation double-blinded study phase total tonic-clonic motor seizure count. The total tonic-clonic motor seizure counts between baseline and the continuous stimulation double-blinded study phase will be compared to see if there was a reduction from baseline. | Total tonic-clonic seizure count at baseline are for the 3 months prior to invasive EEG investigation. Total tonic-clonic seizure count at continuous stimulation double-blinded study phase is for 4 months. |
| Change in total tonic-clonic motor seizures between baseline (assessed by Caregiver reported seizures) and continuous 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 continuous stimulation double-blinded study phase total tonic-clonic motor seizure count. The total tonic-clonic motor seizure counts between baseline and the continuous stimulation double-blinded study phase will be compared to see if there was a reduction from baseline. | Total tonic-clonic seizure count at baseline are for the 3 months prior to invasive EEG investigation. Total tonic-clonic seizure count at continuous stimulation double-blinded study phase is for 4 months. |
| Seizure Frequency as Reported by Caregivers' Diary | Caregivers will be contacted biweekly by the study coordinator to minimize missed events and ensure accurate reporting. The frequency of seizures reported by caregivers will serve as the primary metric for statistical analysis. | From the start date of baseline measurement until the end date of the double-blinded phase of the study, assessed up to 33 months. |
| Frequency between participants with research-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0 | Frequency between participants with research-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0. This is a qualitative collection of information via participant report or clinical observation, but will be input as quantitative (e.g., a headache can be classified as "1-Mild, 2-Moderate, and 3-Severe"). | From the date of device implantation until the end date of the double-blind study phase, assessed up to 25 months. |
| Frequency within participants with research-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0 | Frequency within participants with research-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0. This is a qualitative collection of information via participant report or clinical observation, but will be input as quantitative (e.g., a headache can be classified as "1-Mild, 2-Moderate, and 3-Severe"). | From the date of device implantation until the end date of the double-blind study phase, assessed up to 25 months. |
| 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. |
| From the start date of baseline measurement until the end date of the double-blinded phase of the study, assessed up to 33 months. |
| 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. | From the start date of baseline measurement until the end date of the double-blinded phase of the study, assessed up to 33 months. |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |