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Edge AI Neurostimulation Controllers Versus Continuous Therapy for Drug-Resistant Focal Epilepsy

2026年10月28日 更新者：Hania Aamir、Lahore Medical and Dental College

Edge Computing Artificial Intelligence Neurostimulation Controllers Versus Standard Continuous Therapy for Drug Resistant Focal Epilepsy: A Randomized Controlled Trial

Drug-resistant focal epilepsy remains a major therapeutic challenge. Conventional neurostimulators rely on static, continuous open-loop stimulation or low-bandwidth reactive loops that suffer from classification latency or high battery consumption. This prospective, double-blind, randomized controlled trial evaluates whether hardware-integrated edge computing artificial intelligence (AI) neurostimulators demonstrate superior seizure reduction, lower processing latency, and reduced battery drain compared to standard continuous neurostimulation therapy over a 6-week intervention period.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Eighty adult patients with drug-resistant focal epilepsy undergoing intracranial lead implantation across tertiary referral centers were randomized 1:1 post-implantation into two parallel groups: Edge Computing AI Neurostimulation: Received localized on-hardware machine learning feature extraction and pre-ictal spike classification from intracranial EEG, triggering adaptive targeted high-frequency electrical impulse bursts. Standard Continuous Therapy: Received conventional fixed-frequency, open-loop electrical neurostimulation. The trial evaluated clinical seizure frequency tracked via direct intracortical telemetry logs validated by daily patient diaries, as well as operational hardware metrics including microchip classification latency, real-time inference execution loads, and daily milliampere-hour battery consumption over 6 weeks.

研究类型

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 巴基斯坦
    • Punjab Province
      • Lahore、Punjab Province、巴基斯坦、54570
        • Tertiary Neurosurgical Referral Hospitals

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Diagnosed with refractory (drug-resistant) focal epilepsy.
  • Minimum of four electroclinically documented disabling focal seizures per month despite compliance with two or more appropriately chosen antiseizure medications.
  • Scheduled for clinical intracranial lead implantation (subdural grid or depth electrodes).
  • Aged 18 to 65 years at the time of enrollment.

Exclusion Criteria:

  • Diagnosis of primary generalized epilepsy.
  • Progressive neurological disorders.
  • Severe cognitive impairment.
  • Active psychiatric conditions.
  • Previous cranial neurostimulation implants.
  • Medical contraindications to surgical implantation or continuous intracortical telemetry.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Edge Computing AI Neurostimulation

Participants received an implantable neurostimulator running local edge computing machine learning algorithms to classify pre-ictal spikes from intracortical EEG in real time, delivering adaptive targeted electrical impulse bursts.
设备：Edge AI Neurostimulator Controller

Hardware-integrated neural processing engine executing real-time feature extraction and pre-ictal spike classification from intracranial EEG, triggering adaptive electrical bursts.
有源比较器：Standard Continuous Therapy

Participants received continuous open-loop static neurostimulation delivering fixed-frequency electrical pulses regardless of underlying electrical activity.
设备：Continuous Open-Loop Neurostimulator

Static, fixed-frequency continuous open-loop electrical pulse stimulation delivered regardless of underlying electrical activity.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Monthly Clinical Focal Seizure Frequency
大体时间：Baseline and Week 6 (completion of intervention)

Number of clinical focal seizures per month, recorded continuously via automated direct intracortical telemetry logs and verified against daily patient seizure diaries
Baseline and Week 6 (completion of intervention)

次要结果测量

结果测量
措施说明
大体时间
Microchip Pre-Ictal Classification Latency
大体时间：Continuously across the 6-week intervention

Local on-hardware signal processing and classification response time measured in milliseconds (ms) from raw intracranial EEG pattern identification to trigger execution.
Continuously across the 6-week intervention
Daily Battery Drain Rate
大体时间：Continuously across the 6-week intervention

Average daily battery consumption rate measured in milliampere-hours per day (mAh/day) from device telemetry logs.
Continuously across the 6-week intervention
Real-Time Microchip Inference Load
大体时间：Continuously across the 6-week intervention

Percentage of microchip processing capacity utilized during real-time on-device machine learning execution.
Continuously across the 6-week intervention
Number of Participants with Adverse Events
大体时间：Throughout the 8-month trial duration

Hardware-related, surgical, or neurological adverse events documented throughout the trial.
Throughout the 8-month trial duration

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Lahore Medical and Dental College

调查人员

  • 首席研究员：Ammar Khalil、University of Kotli

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年6月1日

初级完成 (实际的)

2024年1月1日

研究完成 (实际的)

2024年1月1日

研究注册日期

首次提交

2026年10月28日

首先提交符合 QC 标准的

2026年10月28日

首次发布 (实际的)

2026年11月3日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月28日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • UoK1117A

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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