Sleep-Driven Adaptive Neuromodulation in Lennox-Gastaut Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 4
- 主要终点
- 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).
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Personalized aDBS
Participants will receive the Personalized Adaptive DBS Therapy.
干预措施: Personalized Adaptive Deep Brain Stimulation Therapy (Device)
cDBS
Participants will receive the Conventional Non-Personalized DBS Therapy.
干预措施: Conventional Non-Personalized Deep Brain Stimulation Therapy (Device)
结局指标
主要结局
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).
时间窗: 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.
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).
时间窗: 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.
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).
时间窗: 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.
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).
时间窗: 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.
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).
时间窗: 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.
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).
时间窗: 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.
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).
时间窗: 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.
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).
时间窗: 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.
Seizure Frequency as Reported by Caregivers' Diary
时间窗: 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.
Frequency between participants with research-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0
时间窗: 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").
Frequency within participants with research-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0
时间窗: 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").
次要结局
- Participant sleep quality as assessed by Pittsburgh Sleep Quality Index questionnaire.(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(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(From the start date of baseline measurement until the end date of the double-blinded phase of the study, assessed up to 33 months.)