Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E (Lifestyle Interventions for Epilepsy)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Change in Everyday Functioning
研究概览
简要总结
The goal of this clinical trial is to test if cognitive interventions in those with diagnosed epilepsy can help lessen cognitive lapses and improve overall brain health.
Participants will participate in weekly, virtual group sessions led by a neuropsychologist for 12 weeks. After the 12-week mark, participants will be asked to practice what they learned for 9 more months. Participants will be asked to complete online questionnaires at certain times during the study. Researchers will compare this intervention group to another group that did not get the intervention to see if the intervention improves brain health. Participation in each of these groups will be randomly assigned. Participation in the study will last for one year.
详细描述
In this prospective, controlled, randomized study, investigators aim to assess the effectiveness of a cognitive intervention in improving daily function (primary outcome) in those with epilepsy. Investigators will also seek to understand how the cognitive intervention may impact objective and subjective cognitive function, quality of life, self-efficacy, locus of control, and mood (secondary outcomes).
The study team will accomplish these objectives by comparing participants that are randomly assigned to the cognitive intervention arm (12 weekly virtual group sessions led by a neuropsychologist followed by 9 months of "self-study" in addition to their standard care) to participants randomly assigned to the control arm (continuation of their standard care during the 12 months of the study). Investigators will measure the effects of the intervention using cognitive assessments, and health and quality of life questionnaires. Investigators will also collect human biospecimens of enrolled participants to assess the biologic impact of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Potential patients will be identified if they have been, or are scheduled to be seen, either in-person or virtually for a clinical visit within the Cleveland Clinic Epilepsy Center
- •Adults, aged 18-60 years old, with diagnosed epilepsy
- •Subjective cognitive difficulties based on patient self-report or objective cognitive deficits as determined by neuropsychological tests
- •Able to independently provide informed consent
- •Fluent in English
- •Reading abilities at or above 8th grade level as determined by the Wide Range Achievement Test- 4th Edition (WRAT-4), Reading subtest
- •Internet access and the ability to participate in online video streaming
- •No history of resective or ablative epilepsy surgery
- •Willing and able to participate in cognitive intervention
排除标准
- •Patients with a current diagnosis of non-epileptic or psychogenic seizures
- •Any patient that has engaged in any form of cognitive rehabilitation/intervention within the last 6 months
- •Patients currently enrolled in another interventional study for epilepsy at the time of enrollment
- •Anticipated or scheduled epilepsy surgery within 6 months
- •Pending litigation related to the cause of epilepsy unless litigation is related to disability application
- •Undergoing intensive medical treatment for serious or life-threatening illness (e.g., chemotherapy, etc.) that, in the opinion of the investigator, would impact study participation
- •Serious psychiatric condition that, in the opinion of the investigator, would interfere with participation, such as schizophrenia, active psychosis, active mania, and current suicidal ideation
- •Currently pregnant or less than 6 weeks postpartum
- •Significant hearing and/or vision loss that, in the opinion of the investigator would preclude them from participating in remote cognitive testing and engaging in the cognitive intervention
- •Participants who require an LAR or lack capacity to consent for themselves
研究组 & 干预措施
Cognitive Intervention
Participants in this group will receive weekly, live, virtual group sessions for 12 weeks
干预措施: Cognitive Intervention (Behavioral)
Control
Participants in this group will NOT receive the group sessions
结局指标
主要结局
Change in Everyday Functioning
时间窗: 3-12 months from the beginning of the intervention
As assessed by the Instrumental Activities of Daily Living-Compensation (IADL-C) questionnaire - Min/Max: 27-216 (higher score means worse outcome)
次要结局
- Change in Cognitive function(3-12 months)
- Change in Quality of Life(3-12 months)
- Change in Stress(3-12 months)
- Change in Mood(3-12 months)
研究者
Kayela Arrotta
Principal Investigator
The Cleveland Clinic