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临床试验/NCT06364085
NCT06364085尚未招募不适用

EPI-BOOST: Enhancing Epilepsy Management With Precision Deep Brain Stimulation

Nova Scotia Health Authority2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
2
主要终点
Seizure reduction

研究概览

简要总结

The goal of this study is to evaluate the effectiveness of objective neural response feedback on deep brain stimulation (DBS) programming for drug-resistant epilepsy in a prospective observational cohort study.

详细描述

Aim 1: To objectively monitor epilepsy burden with the provided sensing capabilities of the DBS leads by quantifying the association between neuronal activity and seizure frequency

Aim 2: To use the neuronal activity to inform programming of DBS for patients with epilepsy, and assess the impact on patient and caregiver quality of life and hospital costs.

Epilepsy is a neurological disorder characterized by recurrent, unprovoked seizures that affects millions of individuals worldwide and poses a significant burden on their quality of life. Despite considerable advancements in treatment strategies, approximately one-third of patients are considered to have drug-resistant epilepsy. Patients with drug-resistant epilepsy frequently visit the emergency room, are hospitalized regularly, and have many seizure-related injuries. Deep brain stimulation (DBS) offers a unique treatment option by delivering precise electrical pulses with surgically implanted electrodes to the specific brain regions responsible for seizures, disrupting the seizure pathways. Long-term favorable findings showing significant seizure reduction at five-year post-implantation for patients who otherwise have no treatment options have convinced many centers to incorporate DBS into their healthcare practise.

For assessing the treatment response in epilepsy, healthcare providers are dependent on patient-reported seizure diaries. Recent research in DBS has focused on the biological implications of neuronal recordings through the implanted electrodes. These signals offer objective insight into brain activity, specifically epileptic burden, and offers potentially predictive capabilities. Current research focuses on whether the sensing capabilities of DBS can provide reliable seizure burden detection, and whether this can be achieved with less demand on the patient.

In this prospective observational cohort study, the researchers aim to improve the impact of DBS treatment on the seizure burden and quality of life of patients diagnosed with drug-resistant epilepsy in Atlantic Canada. This will be done by investigating the neural activity underlying epileptic events as a representation of epileptic burden, affording the opportunity to tailor DBS interventions with more precision and efficiency.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients qualifying for deep brain stimulation on the basis of drug-resistant epilepsy
  • Informed consent

排除标准

  • Lack of consent
  • Electrical or other devices that preclude the performance of an MRI for pre-operative imaging

结局指标

主要结局

Seizure reduction

时间窗: Change from baseline versus Month 12

The number of seizures experienced by patients will be assessed by the number of seizures recorded by patients and their caregivers in seizure diaries and described as absolute seizure reduction.

次要结局

  • Change in disease score on Patient Weighted Quality Of Life In Epilepsy(Twelve months)
  • Change in depression score on Neurological Disorders Depression Inventory in Epilepsy(Twelve months)
  • Change in anxiety score on Anxiety General Anxiety Disorder-7(Twelve months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lutz Weise

Principal Investigator

Nova Scotia Health Authority

研究点 (2)

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