FORESITE (FOREcasting Seizures to Initiate ThErapy): Optimizing Management of Drug-Resistant Epilepsy Using Seizure Forecasts Via Subscalp EEG and Wearables
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Safety- cardiorespiratory events
研究概览
简要总结
Mayo Clinic is conducting a research study to test a new approach to managing seizures in people with epilepsy whose seizures have not been fully controlled with regular medications. The study uses a small sensor placed just under the skin (not inside the brain) that continuously records electrical brain activity. This information is used to train a personalized computer algorithm that learns your individual seizure patterns and forecasts when a seizure is more likely to occur. If you are eligible and choose to participate, you would receive advance warning of elevated seizure risk, allowing you to take a fast-acting medication before a seizure happens. This medication would be in addition to the regular medicines prescribed by your doctor. The goal of the study is to understand whether this kind of forecasting system is safe, comfortable to live with, and capable of helping people gain more control over their seizures with a minimum amount of additional medication.
Participation involves a minor surgical procedure to implant a small electrode under the skin above your ear that records your brain's electrical signals continuously over time. You would also wear a smart watch during the study. For the first six months, the system collects data to personalize your seizure forecast model and would not give you an alert. In the second six months, we would calculate your daily seizure risk and you would receive alerts on days when your risk is elevated. On these higher seizure risk days you would take a prescribed fast-acting nasal spray medication. The study is open to adults who continue to have 2 or more seizures per month in spite of having tried at least two antiseizure medications in the past, and whose seizures have shown involvement of the temporal lobe. All study-related procedures, devices, and study medication are provided at no cost to participants. Participants receive financial compensation for their time, and travel expenses to and from Mayo Clinic Rochester are reimbursed for anyone traveling more than 100 miles. If you are interested in learning more, please contact our research coordinator by email at Laivell.Jeffrey@mayo.edu.
详细描述
For most people with epilepsy, seizures do not appear to happen on a predictable schedule, but recent research shows that seizure risk may actually rise and fall in patterns over time, similar to other body rhythms. Right now, most people with drug-resistant epilepsy (epilepsy that has not responded well to medications) take antiseizure medication every day, whether or not their seizure risk is high that day, which means they deal with side effects every day even though seizures happen only sometimes. This study tests using a small implanted sensor and a wearable device to predict when a person's seizure risk is elevated, and then giving a fast-acting medication in advance, before a seizure happens. The goal is to find out whether this approach is safe and workable in everyday life.
This study will enroll adults with drug-resistant epilepsy that involves the temporal lobe, at Mayo Clinic in Rochester, Minnesota, Jacksonville, Florida, and Phoenix, Arizona.
Each participant has a small device called the UNEEG SubQ placed just under the scalp, in a minor surgical procedure. This device does not go into the brain itself. It sits under the skin and continuously records the brain's electrical activity. Participants also wear an smart watch to track heart rate and movement, and they keep a daily seizure diary on a smartphone.
The study takes place over about 12 months for each participant, in three parts.
Part 1, the first three months: The device and watch collect data in the background. No warnings or predictions are shown to the participant during this time. This information is used to build a personalized computer model that learns each person's individual patterns of seizure risk. For four weeks during this period, participants take a scheduled dose of VALTOCO (a nasal spray form of the medication diazepam) once a week, which helps the research team see how the medication affects the recorded brain activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects enrolled in this study must have epilepsy involving the temporal lobe and will have undergone video-EEG monitoring within the past 3 years, and will have met the following criteria:
- •Focal epilepsy, including complex partial, and secondarily generalized seizures, including:
- •disabling seizure (i.e. involving loss of awareness, motor control, speech, or other essential functions) counts at least 2 per month on average over the preceding 3 months, established by verbal history or caregiver report.
- •For 3 months prior to enrollment, subject's AED dosages have been stable (less than a 25% change in dosage) and subject has had at least two seizures per month, on average, with a seizure-free interval not to exceed 60 days. Seizures must be separated by a minimum of four hours not to be considered part of a cluster. A cluster, for the purpose of this criterion, shall be considered a single seizure.
- •With the exception of epilepsy, subject must be medically and neurologically stable.
- •Age 18 to
- •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 subject or caregiver, and have a distinct EEG pattern that can be recorded using subscalp EEG over the frontotemporal head region, established by video-EEG monitoring.
- •Subject can reasonably be expected to maintain a seizure diary alone or with the assistance of a competent individual.
- •Subject is able to complete regular office visits and telephone appointments in accordance with the study protocol requirements.
- •Subject's seizure focus, based upon clinical semiology, scalp EEG, intracranial electroencephalographic (iEEG) findings, and/or neuroimaging, demonstrate consistent involvement of the temporal lobe with their EEG seizure pattern.
- •Subject speaks and reads English.
- •Subject has no reason to anticipate requiring a magnetic resonance imaging (MRI) evaluation within the next two years.
- •Subject has EEG documentation of ictal events consistent with his or her predominant current seizure type.
- •Subject's anatomy will permit implantation of the UNEEG SubQ device in the opinion of the study's neurosurgeon.
- •Female subjects have a negative pregnancy test, have no plans to become pregnant, and use effective contraception during the study.
排除标准
- •For 3 months prior to enrollment, subject's AED dosages have not been stable (greater than 25% change in dosage), or subject has had more than 30 disabling seizures per month, on average, or more than 10 seizure days per month, on average.
- •Subject needs to have magnetic resonance imaging during the study period.
- •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, brain stimulator, or other medical device that would interfere with the UNEEG device. This includes, but is not limited to, direct brain neurostimulators, spinal cord stimulators, and cochlear implants. Vagus nerve stimulators are not expected to interfere with the subscalp EEG device and will be permitted, as long as stimulation parameters can be reasonably expected to remain stable (25% or less change in amplitude) throughout the study.
- •Subject has experienced unprovoked status epilepticus.
- •Subject has had therapeutic surgery to treat epilepsy that may interfere with electrode placement in the judgement of the neurosurgeon.
- •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. Blood tests to evaluate platelet and bleeding disorder issues will be obtained prior to enrollment.
- •Subject is otherwise ineligible for cranial surgery, or the Investigators identify other medical or psychosocial factors that would counter indicate participation in the study.
- •Subject has a known diagnosis of psychogenic nonepileptic seizures (PNES)
- •Female subject is pregnant or plans to become pregnant.
- •Subject is known to require rescue medication for seizure clusters
- •Subject has a history of a paradoxical reaction to benzodiazepines including agitation, hyperactivity, or aggression.
- •Subject has a known diagnosis of acute narrow-angle glaucoma
研究组 & 干预措施
subscalp EEG
All study subjects will be implanted with the UNEEG SubQ device and will receive forecasts of daily seizure risk.
干预措施: Preventative Medication (PM) (Drug)
subscalp EEG
All study subjects will be implanted with the UNEEG SubQ device and will receive forecasts of daily seizure risk.
干预措施: UNEEG SubQ device, seizure forecasts, nasal diazepam (Device)
结局指标
主要结局
Safety- cardiorespiratory events
时间窗: 12 months
no observed drug-related serious cardiorespiratory events
Feasibility outcome
时间窗: 12 months
greater than 75% data collection adherence (18 hours/day) with the UNEEG and Apple Watch systems on average during the prospective forecasting portion of the study for over 90% of participants
Preseizure alert feasibility
时间窗: 12 months
greater than 80% of pre-seizure alerts resulting in VALTOCO administration within 90 minutes in over 90% of participants
Safety and Adverse Events
时间窗: 12 months
VALTOCO discontinuation rate due to TEAE below 10% of subjects
Surgical and Device related adverse events
时间窗: 12 months
Following surgery adverse events related to surgery and the device will be assessed, including: pain/soreness at the surgical site up to 1 week after surgery, pain/soreness at the surgical site after more than 1 week after surgery, headache (nonsurgical), skin irritation at transceiver position, excess bleeding, and infection; additionally, skin erosion will be assessed, and lead migration and fracture will be assessed by x-ray, if there is any concern for this, at the time of study completion prior to explantation.
次要结局
- Reduction in seizure rates during the prospective phase of the trial compared to baseline(12 months)
- Quality of Life Inventory and seizure related impact scores(Baseline, 6 months, 12 months)
- Seizure related severity score(Baseline, 6mo, 12mo)
- Seizure related severity score(Baseline, 6months, 12months)
- Quality of Life Inventory(12 months)
研究者
Benjamin H. Brinkmann
Principal Investigator
Mayo Clinic