NCT06424977尚未招募不适用
Safety and Effectiveness of Biomarker Targeted Stimulation in Epilepsy
Cadence Neuroscience0 个研究点目标入组 40 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Adverse event rate
研究概览
简要总结
This is a multicenter, prospective, controlled study designed to evaluate treatment with the BTS System.
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
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject is greater than or equal to 7 years of age.
- •Subject has focal onset seizures.
- •Subject has failed treatment with a minimum of two AED's used in typical therapeutic dosages.
- •Subject has seizures that are distinct, stereotypical events that can be reliably counted by the patient or caregiver.
- •Subject can reasonably be expected to maintain a seizure diary and the BTS System alone, or with the assistance of a competent individual.
- •For one month prior to enrollment, subject's anti-epileptic medication dosages and ketogenic diet (as applicable) have been stable (other than acute, intermittent use of benzodiazepines) and subject has had at least three primary, disabling seizures per month, on average. Seizures must be separated by a minimum of eight hours not to be considered part of a cluster. A cluster, for the purpose of this criterion, shall be considered a single seizure.
- •Subject is able to complete regular office visits and telephone appointments in accordance with the study protocol requirements.
- •A female subject of childbearing age must have a negative serum pregnancy test within two weeks prior to implant of the INSR, and, if sexually active, must be using a reliable form of birth control, be surgically sterile, or be at least two years post-menopausal.
- •Subject has been informed of their eligibility for resective surgery as a potential alternative to the study, if such surgery is a reasonable option.
- •Subject has had a brain MRI epilepsy evaluation within the past two years.
- •Subject's anatomy will permit implantation of the INSR within 20 mm of the skin surface.
排除标准
- •Subject has a history of substance abuse within the preceding two years.
- •Subject participated in another drug or device trial that may confound study results within the preceding 30 days.
- •Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, or a medical device that interferes with the BTS System or with which the BTS System interferes. Patients with a vagus nerve stimulator (VNS) implanted may be enrolled, provided their clinical status has been stable for at least one month prior to enrollment at their current stimulation parameter settings.
- •Subject has anatomy that may interfere with electrode placement.
- •Subject is on anticoagulants and is unable to discontinue them perisurgically, as required by the neurosurgeon or Investigator.
- •Subject has significant platelet dysfunction from medical conditions or medications (including, particularly, aspirin or sodium valproate). If platelet dysfunction is suspected, subject can be enrolled only if a hematologist, the Investigator, and the neurosurgeon judge it to be advisable.
- •Subject has been diagnosed with psychogenic or non-epileptic seizures that cannot be distinguished from their epileptogenic events.
- •Subject is ineligible for cranial surgery.
研究组 & 干预措施
Treatment
Experimental
干预措施: Biomarker Targeted Stimulation (BTS) (Device)
结局指标
主要结局
Adverse event rate
时间窗: Intervals through 7, 12, and 24 months post-implant
Determine adverse event rate, including adverse device effects and serious adverse events
次要结局
- Caregiver burden testing(Evaluated at 7 months, 12 months, and 24 months post-implant.)
- Quality of life testing(Evaluated at 7 months, 12 months, and 24 months post-implant.)
- Neurocognitive testing(Evaluated at 7 months, 12 months, and 24 months post-implant.)
- Depression testing(Evaluated at 7 months, 12 months, and 24 months post-implant.)
- Anxiety testing(Evaluated at 7 months, 12 months, and 24 months post-implant.)
- Seizure severity testing(Evaluated at 7 months, 12 months, and 24 months post-implant.)
- Seizure frequency(Intervals calculated at 4 to 7 months and through 12 and 24 months post-implant.)
- Sleep testing(Evaluated at 7 months, 12 months, and 24 months post-implant.)
研究者
相似试验
已完成
2 期
Biomarker-driven Targeted Therapy in Patients With Recurrent Platinum-resistant Epithelial Ovarian CancerOvarian CancerNCT05044871Tongji Hospital108
已完成
1 期
Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy SubjectsHealthy AdultNCT02257151Bristol-Myers Squibb118
已完成
2 期
The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate HypercholesterolemiaHypercholesterolemiaNCT00405067Aegerion Pharmaceuticals, Inc.60
已完成
3 期
Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in ChildrenPainNCT01324570Purdue Pharma LP41
已完成
1 期
Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant MelanomaMalignant MelanomaNCT01024231Bristol-Myers Squibb127