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Sleep-Driven Adaptive Neuromodulation in Lennox-Gastaut Syndrome (ADAPT LGS)

6 de mayo de 2026 actualizado por: 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:

  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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

4

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Adam Hansen
  • Número de teléfono: 763-807-1858
  • Correo electrónico: hans5057@umn.edu

Copia de seguridad de contactos de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Personalized aDBS
Participants will receive the Personalized Adaptive DBS Therapy.
Dispositivo: Personalized Adaptive Deep Brain Stimulation Therapy
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.
Comparador activo: cDBS
Participants will receive the Conventional Non-Personalized DBS Therapy.
Dispositivo: Conventional Non-Personalized Deep Brain Stimulation Therapy
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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
Periodo de tiempo: From the start date of baseline measurement until the end date of the double-blinded phase of the study, assessed up to 33 months.
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
Periodo de tiempo: 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").
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
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant sleep quality as assessed by Pittsburgh Sleep Quality Index questionnaire.
Periodo de tiempo: From the start date of baseline measurement until the end date of the double-blinded phase of the study, assessed up to 33 months.
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.
Participant quality of life as assessed by health-related, patient-centered Quality of Life in Neurological Disorders (Neuro-Qol) questionnaire
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
From the start date of baseline measurement until the end date of the double-blinded phase of the study, assessed up to 33 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Minnesota

Investigadores

  • Investigador principal: Sandipan Pati, MBBS, University of Minnesota

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

30 de septiembre de 2030

Finalización del estudio (Estimado)

30 de septiembre de 2031

Fechas de registro del estudio

Enviado por primera vez

22 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de abril de 2026

Publicado por primera vez (Actual)

6 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY00027660

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified data may be shared for future use.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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