Human Safety and Feasibility Study of Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy

Mayo Clinic1 个研究点分布在 1 个国家目标入组 5 人2019年1月18日

适应症Epilepsy

干预措施Medtronic Summit System, Olympus

概览

阶段: 不适用
干预措施: Medtronic Summit System, Olympus
疾病 / 适应症: Epilepsy
发起方: Mayo Clinic
入组人数: 5
试验地点: 1
主要终点: Tracking cognition
状态: 进行中（未招募）
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

Researchers are trying to determine if tracking seizure occurrence, seizure probability, behavioral state, cognition, and mood can be achieved using an implantable brain sensing and stimulation device (Medtronic RC+S Summit) coupled to an external, handheld, patient assistant device (PAD) with capability for patient interaction (patient data input). The system (RC+S & PAD) provides intracranial EEG (iEEG) sensing, electrical brain stimulation, and machine learning algorithms running on the RC+S and PAD that will be coupled with electrical brain stimulation (EBS) to prevent seizures and improve quality of life in patients with epilepsy.

详细描述

This study will include patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy. The plan is to have 10 patients take part in this study at Mayo Clinic Rochester.

注册库

clinicaltrials.gov

开始日期

2019年1月18日

结束日期

2027年2月1日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Mayo Clinic

责任方

Principal Investigator

主要研究者

Gregory Worrell

Principal Investigator

Mayo Clinic

入排标准

入选标准

•Focal epilepsy, including seizures with and without impairment of consciousness, and secondarily generalized seizures:
•Disabling seizure counts \>3 per month (Disabling seizures are those with significant negative impact on the patients life)
•Drug resistance to \>2 appropriate seizure drugs with therapeutic serum concentrations
•Not a good candidate for resective surgery or at significant risk for verbal memory decline as determined by our institution's multidisciplinary Epilepsy Surgery Committee.
•For 3 months prior to enrollment, subject's anti-seizure medication dosages have been stable and subject has had at least 6 disabling (as defined in Inclusion Criteria 1) seizures per month, on average, with a seizure-free interval not to exceed 30 days. Seizures must be separated by a minimum of eight hours not to be considered part of a cluster. A cluster of seizures, for the purpose of this criterion, shall be considered a single seizure.
•With the exception of epilepsy, subject must be medically and neurologically stable.
•Mayo Clinic Epilepsy Surgery Committee approval for brain stimulation therapy obtained on clinical grounds and without reference to this protocol.
•Age 18 to 75
•Ability and willingness to provide informed consent and participate in the study protocol. Subject is able to interpret and to respond, in accordance with the study protocol, to the advisory indicators provided by the device.
•Subject has seizures that are distinct, stereotypical events that can be reliably counted by the patient or caregiver.

排除标准

•For 3 months prior to enrollment, subject's anti-seizure medication dosages have not been stable, or subject has had more than 25 disabling (as defined in Inclusion Criteria 1) seizures per month, on average, or there was a seizure-free interval longer than 30 days within the past 3 months. Clinical seizures must be separated by a minimum of eight hours to not be considered part of a cluster. Cluster seizures are considered a single seizure event.
•Subject has a contraindication to magnetic resonance imaging.
•Subject has a substance abuse history (alcohol, prescription, or illicit medications) within the preceding two years.
•Subject participated in another drug or device trial within the preceding 30 days.
•Subject has been hospitalized for a psychiatric condition within the preceding two years or has had a history of psychosis within the preceding two years (excluding post-ictal psychosis).
•Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, or a medical device that interferes with the RC+S device. This includes, but is not limited to, direct brain neurostimulators, spinal cord stimulators, vagus nerve stimulators (VNS), and cochlear implants. Patients with a vagus nerve stimulator implanted but turned off through the duration of the study may be enrolled, provided their clinical status has been stable for at least one month with VNS turned off. Alternatively, patients with a VNS may have the previously disabled VNS removed at time of surgery to implant the Medtronic RC+S.
•Subject has been diagnosed with psychogenic or non-epileptic seizures.
•Subject has been diagnosed with primary generalized seizures.
•Subject has experienced unprovoked status epilepticus in the preceding year.
•Subject has had therapeutic surgery to treat epilepsy that may interfere with electrode placement.