Neuroimaging Biomarker for Seizures
试验速览
- 阶段
- 不适用
- 入组人数
- 224
- 试验地点
- 6
- 主要终点
- Number of Epileptic Seizures
研究概览
简要总结
This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging.
详细描述
Numerous Veterans and civilians have seizures, which can be epileptic or nonepileptic in nature. Epileptic seizures are caused by abnormal brain cell firing. Nonepileptic seizures appear similar to epileptic seizures, but are associated with traumatic experiences and underlying psychological stressors. Both types of seizure are common and disabling, and many patients with seizures do not have adequate control resulting in loss of quality of life.
In this proposed 3-site study ( Providence, RI and Birmingham, AL), which are epilepsy centers with expertise both in epilepsy and psychogenic nonepileptic seizures (PNES), we will enroll 88 patients with video-EEG confirmed PNES and 88 with confirmed post-traumatic epilepsy (PTE) and will obtain functional neuroimaging before and after they receive a behavioral treatment - Cognitive Behavioral Therapy for Seizures. The functional neuroimaging studies in these patients will be compared to patients with traumatic brain injury without seizures to test the hypothesis that the faulty processing of emotions and stress in patients with PNES/PTE and abnormal brain connectivity have unique signals in patients with seizures compared to Veterans without seizures and that the neuroimaging signatures can be modified using behavioral intervention.
Impact: This grant application for the first study investigating mechanisms of PNES and PTE will provide increased understanding of neural circuitry in PTE and PNES, which can inform PTE and PNES treatments and could change clinical neurologic and psychiatric practice for PTE and PNES.
Participants will be recruited at the Providence VA Medical Center, Rhode Island Hospital, and University of Alabama, Birmingham (UAB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The neuroimaging analysis will be masked.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for PNES, ES and TBI (w/o PNES or ES) participants
- •Individuals with history of documented TBI (any severity).
- •Males and Females ages 18-60 years .
- •Women of child bearing potential, if currently using appropriate contraception.
- •Inclusion criteria of PNES and ES participants.
- •Diagnosed by video/EEG with lone PNES or by EEG with lone ES.
- •Patients must have at least 1 PNES or 1 ES during the year prior to enrollment.
排除标准
- •Exclusion Criteria of PNES, ES and TBI (w/o PNES or ES) participants
- •Current or past year self-injurious behavior.
- •Current suicidal intent (BDI suicide question 9 score of >1).
- •Current or past year psychosis.
- •Pending litigation or current application for long term disability.
- •Active substance or alcohol use disorder (dependence), per discretion of the investigators.
- •Serious illness requiring systemic treatment or hospitalization; the participant either completes therapy or is clinically stable on therapy, for at least 30 days prior to study entry.
- •Inability to fill out the self-report surveys.
- •Women who are or/are attempting to become pregnant during the study.
- •Ineligible or unwilling to complete MRI imaging.
- •Inability to document TBI.
- •Exclusion Criteria for PNES and ES participants
- •Inability or unwillingness to participate in CBT and assigned homework.
- •Currently enrolled in cognitive therapy aimed at PNES (Current CBT or other psychotherapy may be administered).
- •Concurrent mixed ES/PNES or equivocal video/EEG findings in discerning between ES and PNES will not be enrolled.
结局指标
主要结局
Number of Epileptic Seizures
时间窗: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
epileptic seizure frequency (ES), collected prospectively, using a daily seizure calendar
Number of Nonepileptic Seizures (NES)
时间窗: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar
Structural and Functional Neuroimaging
时间窗: Baseline and week 13
Brain MRI scans
次要结局
- Beck Depression Inventory-II (BDI-II)(Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline)
- Beck Anxiety Inventory (BAI)(Baseline, Weeks 6 and 10, 8 months post baseline, 12 months post baseline)
- Quality of Life in Epilepsy-31 (QOLIE-31)(Baseline, Weeks 6 and 10)