Sleep-Driven Adaptive Neuromodulation in Lennox-Gastaut Syndrome (ADAPT LGS)
6. května 2026 aktualizováno: University of Minnesota
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:
- Does using the personalized DBS reduce motor seizures compared to conventional DBS?
- Is the number of seizures reported by caregivers different for patients using the personalized DBS?
- 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:
- Have their seizures and sleep patterns recorded for 3-months
- Assess their neurocognitive function
- Answer questionnaires about communication, movement, and sleep quality
- Wear a sleep headband and seizure warning watch for 5 nights
- Complete a mood and sleep assessment
- Have a 3T and possibly 7T MRI
- Be implanted with stereo-encephalography and undergo 3~5 days of monitoring
- Have the stereo-encephalography taken out
- Receive DBS implantation through surgery and have several months of stimulation and no stimulation periods
- Have routine clinical visits to check on healing after surgery
- Have their caregiver help them keep a dairy about their seizures, sleep and quality of life
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Typ studie
Intervenční
Zápis (Odhadovaný)
4
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Adam Hansen
- Telefonní číslo: 763-807-1858
- E-mail: hans5057@umn.edu
Studijní záloha kontaktů
- Jméno: Monica Bondy
- E-mail: bondy023@umn.edu
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Personalized aDBS
Participants will receive the Personalized Adaptive DBS Therapy.
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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.
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Aktivní komparátor: cDBS
Participants will receive the Conventional Non-Personalized DBS Therapy.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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).
Časové okno: 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.
|
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).
Časové okno: 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.
|
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).
Časové okno: 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.
|
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.
|
|
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).
Časové okno: 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.
|
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).
Časové okno: 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.
|
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).
Časové okno: 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.
|
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).
Časové okno: 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.
|
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).
Časové okno: 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.
|
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
Časové okno: 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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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.
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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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Frequency between participants with research-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0
Časové okno: From the date of device implantation until the end date of the double-blind study phase, assessed up to 25 months.
|
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").
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From the date of device implantation until the end date of the double-blind study phase, assessed up to 25 months.
|
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Frequency within participants with research-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0
Časové okno: 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.
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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Participant sleep quality as assessed by Pittsburgh Sleep Quality Index questionnaire.
Časové okno: 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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The minimum score is 0 and the maximum score is 21, with lower scores meaning better sleep quality.
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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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Participant quality of life as assessed by health-related, patient-centered Quality of Life in Neurological Disorders (Neuro-Qol) questionnaire
Časové okno: 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 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.
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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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Participant quality of life as assessed by Patient-Reported Outcomes Measurement Information System-Profile 57 (PROMIS-57) version 2.1
Časové okno: From the start date of baseline measurement until the end date of the double-blinded phase of the study, assessed up to 33 months.
|
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.
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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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Sandipan Pati, MBBS, University of Minnesota
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. října 2026
Primární dokončení (Odhadovaný)
30. září 2030
Dokončení studie (Odhadovaný)
30. září 2031
Termíny zápisu do studia
První předloženo
22. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
30. dubna 2026
První zveřejněno (Aktuální)
6. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
6. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STUDY00027660
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
De-identified data may be shared for future use.
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
Ano
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