Thalamocortical Responsive Neurostimulation for the Treatment of Lennox-Gastaut Syndrome
丘脑皮质反应性神经刺激治疗 Lennox-Gastaut 综合征
基本信息
- 批准号:10414867
- 负责人:
- 金额:$ 259.68万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-06-01 至 2026-05-31
- 项目状态:未结题
- 来源:
- 关键词:12 year oldAdverse effectsBilateralBiological MarkersBlindedBrainCentromedian Thalamic NucleusChildhoodClinicalClinical ResearchClonic SeizureComputer ModelsCrossover DesignDataDecision Support SystemsDeep Brain StimulationDetectionDevice DesignsDevicesDiffusion Magnetic Resonance ImagingDiseaseElectrodesElectroencephalographyElectrophysiology (science)ElementsEnrollmentEpilepsyEtiologyEvaluationFDA approvedFeasibility StudiesFollow-Up StudiesFrequenciesFunctional disorderFutureGastaut syndromeGeneralized EpilepsyGenetic Crossing OverGoalsImpaired cognitionImplantInjuryIpsilateralLeadLongterm Follow-upMachine LearningMagnetic Resonance ImagingManualsMedialMedicalMedical ImagingMental DepressionModelingNeuronsOnline SystemsOperative Surgical ProceduresOutcomeParkinson DiseasePathway interactionsPatientsPharmaceutical PreparationsPhysiciansPilot ProjectsPoliciesPopulationPost-Traumatic Stress DisordersPrefrontal CortexRandomizedResearchSafetySeizuresSelection for TreatmentsSingle-Blind StudySystemTestingTimeTonic SeizuresUpdateaddictionatonic seizurebasebiomarker discoverybiophysical modelblindclinical efficacyclinical practicecohortcomputational network modelingdesigndiariesearly experienceeffective therapyimprovedinteractive therapylead optimizationmachine learning methodmortalityneuroimagingneurophysiologyneuroregulationnovelopen labelpotential biomarkerpredict clinical outcomeprototyperecruitresponsesafety testingtool
项目摘要
Project Summary / Abstract
Lennox-Gastaut Syndrome (LGS) is a devastating form of childhood onset epilepsy with cognitive
dysfunction and very frequent generalized onset seizures (GOS) often leading to injury. Driven by the lack of
effective therapies and the demonstrated safety and efficacy of brain-responsive stimulation for medically
intractable focal onset seizures (FOS), this study will test whether brain-responsive neurostimulation of
thalamocortical networks (RNS-TCN) is a feasible strategy to treat LGS. Specifically, the project aims to:
(1) acquire preliminary evidence for safety and efficacy in treating GOS of LGS with RNS-TCN; (2) create an
interactive therapy-decision support system based on patient-specific computational network models and
machine learning to identify optimal lead placement and stimulation parameters.
Using the RNS® System, which is FDA approved for FOS, an early feasibility IDE study will be conducted
at 6 epilepsy centers in 20 patients with LGS and medically intractable GOS. The patients will be enrolled in
two cohorts of 10, with safety and efficacy milestones in the first cohort governing the enrollment of the second
cohort. Patients will have two depth leads placed bilaterally in the centromedian nucleus of the thalamus and
two subdural strip leads placed bilaterally on the medial prefrontal cortex. These targets are selected because
they are implicated in the onset and spread of GOS in LGS. Leads will be located within each target such that
stimulation maximally engages the thalamocortical network, guided by finite-element biophysical models
created from structural magnetic resonance imaging and diffusion weighted imaging. The finite-element
biophysical models will also be used to identify the initial RNS-TCN stimulation pathway and current amplitude.
During the blinded evaluation period patients will be randomized to receive either high-frequency short burst
(HFSB) or low-frequency long burst (LFLB) RNS-TCN, then enter a washout period before crossing over to
receive the other treatment condition. During the open label period stimulation parameters can be modified at
the discretion of the physician. Parameter adjustments will be informed by using a Bayesian optimization
model developed for specifically for each patient. All clinical and electrophysiological data collected during the
study will be used to identify a biomarker of clinical response; if found, these will aid future epilepsy research
and clinical practice. If safety is favorable and there is preliminary evidence for efficacy, then this early
experience will inform the design of a future larger feasibility study.
In addition to treating a population in need, this project engages in fundamental discovery of biomarkers in
generalized network epilepsies, and develops novel automated therapy selection policies that have the
potential to improve the lives of patients with LGS and other seizure disorders.
项目摘要/摘要
项目成果
期刊论文数量(0)
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{{ truncateString('MARTHA J MORRELL', 18)}}的其他基金
Thalamocortical Responsive Neurostimulation for the Treatment of Lennox-Gastaut Syndrome
丘脑皮质反应性神经刺激治疗 Lennox-Gastaut 综合征
- 批准号:
10615330 - 财政年份:2021
- 资助金额:
$ 259.68万 - 项目类别:
Thalamocortical Responsive Neurostimulation for the Treatment of Lennox-Gastaut Syndrome
丘脑皮质反应性神经刺激治疗 Lennox-Gastaut 综合征
- 批准号:
9958791 - 财政年份:2021
- 资助金额:
$ 259.68万 - 项目类别:
Thalamocortical Responsive Neurostimulation for the Treatment of Lennox-Gastaut Syndrome
丘脑皮质反应性神经刺激治疗 Lennox-Gastaut 综合征
- 批准号:
10674542 - 财政年份:2021
- 资助金额:
$ 259.68万 - 项目类别:
Reproductive Function in Women with Bipolar Disorders
双相情感障碍女性的生殖功能
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7045027 - 财政年份:2003
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$ 259.68万 - 项目类别:
EFFECTS OF ANTIEPILEPTIC DRUGS ON BONE TURNOVER AND MASS
抗癫痫药物对骨转换和质量的影响
- 批准号:
6567729 - 财政年份:2001
- 资助金额:
$ 259.68万 - 项目类别:
EFFECTS OF ANTIEPILEPTIC DRUGS ON BONE TURNOVER AND MASS
抗癫痫药物对骨转换和质量的影响
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6468469 - 财政年份:2000
- 资助金额:
$ 259.68万 - 项目类别:
HYPOTHALAMIC-PITUITARY-OVARIAN AXIS IN WOMEN WITH EPILEPSY
女性癫痫患者的下丘脑-垂体-卵巢轴
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6115032 - 财政年份:1998
- 资助金额:
$ 259.68万 - 项目类别:
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暴露于 AED 的癫痫女性的骨骼健康分析
- 批准号:
6115081 - 财政年份:1998
- 资助金额:
$ 259.68万 - 项目类别:
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