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

2026年5月6日 更新者：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

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

4

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Personalized aDBS
Participants will receive the Personalized Adaptive DBS Therapy.
デバイス：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.
アクティブコンパレータ：cDBS
Participants will receive the Conventional Non-Personalized DBS Therapy.
デバイス：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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).
時間枠：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).
時間枠：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).
時間枠：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).
時間枠：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).
時間枠：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).
時間枠：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).
時間枠：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).
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Participant sleep quality as assessed by Pittsburgh Sleep Quality Index questionnaire.
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Minnesota

捜査官

  • 主任研究者：Sandipan Pati, MBBS、University of Minnesota

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月1日

一次修了 (推定)

2030年9月30日

研究の完了 (推定)

2031年9月30日

試験登録日

最初に提出

2026年4月22日

QC基準を満たした最初の提出物

2026年4月30日

最初の投稿 (実際)

2026年5月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月8日

QC基準を満たした最後の更新が送信されました

2026年5月6日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • STUDY00027660

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

De-identified data may be shared for future use.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

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