Behavioral and Pharmacological Manipulation of Time Cell Activity in the Human Mesial Temporal Lobe
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Memory-related changes in brain electrical activity in participants from baseline at Day 1 post-intervention (approx. within 1-3 hrs)
研究概览
简要总结
The goal of this study is to learn about the effects of scopolamine (an anticholinergic drug) on areas of the brain involved in memory, and changes it may have on brain activity. The investigators will do this by testing epileptic patients who are already undergoing intracranial surgery for seizure monitoring, and measuring the activity from the brain areas being assessed.
The main questions it aims to answer are 1) whether scopolamine changes memory activity solely at encoding (the time when the person perceives and determines to remember an item or event) as has previously been found, or if it also can selectively impact retrieval (when the item or event which has been processed is recalled or remembered), and 2) what the nature of the brain activity changes is.
Participants will complete two treatment arms. One of these will be with the drug, and the other will be with a saline solution, so that the participants are unaware which session the actual drug has been received. Patients will complete a verbal and/or spatial task each of the two days. An anesthesiologist will administer either the drug or the saline at a critical point which addresses both of the research questions.
Researchers will compare the brain activity between the two treatment arms to determine what brain activity changes, and at what time point during memory formation.
详细描述
Patient Identification : The study team plans to recruit adult patients who are undergoing invasive electroencephalographic (EEG) monitoring as part of a standard clinical procedure for the treatment of pharmacologically resistant epilepsy at UT Southwestern. Patients are identified from the pool of patients presented at the epilepsy management conference and approached when presented to the clinic for evaluation for seizure surgery.
Study Procedures: Participation takes place only during the time that the electrodes are surgically in place. Active participation will end when the electrodes are removed. The subject may decline to participate in cognitive testing sessions at any given time during intracranial monitoring hospitalization and are informed of the right to leave the study at any time. The neuropsychological tasks described below will be administered by key personnel on the study. The data will be de-identified and converted to signal data for processing and analysis. Study personnel, excluding the PI (aka 'experimenters') will perform analysis.
Once patients are in the epilepsy monitoring unit (EMU), subjects will be randomized to receive either a dose of scopolamine (5ug/kg) or saline (sham) via IV. Approximately 15 minutes after administration, the participant will then complete either an episodic or a spatial memory task session. The following day, or at least four half-lives after the first session, the participant will receive the alternative agent not given the first day. For example, if the patient received Scopolamine the first day, then the saline (sham) is received the second day, and vice versa. The participants will then complete an additional episodic or spatial memory task session approximately 15 minutes after administration. ,
Day 1: Randomized to receive either Scopolamine or saline (sham); Complete episodic or spatial memory task session Day 2: Receives alternate agent from day 1; Completes episodic or spatial memory task session
The time delay between sessions will stay consistent whether scopolamine or saline was administered during the first session. Participants will not be administered more than one dosage during a single session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Scopolamine (0.4mg)
Subjects will receive a dose of scopolamine (0.4mg) on each day. Approximately 15 minutes after administration, the participant will then complete either an episodic or a spatial memory task session.
If the patient completed the sham session already, this session will take place the day following the initial session, or at least four half-lives after the first session.
干预措施: Scopolamine (0.4mg) (Drug)
Placebo
Subjects will receive saline (0.4mg) via IV on each day. Approximately 15 minutes after administration, the participant will then complete either an episodic or a spatial memory task session.
If the patient completed the scopolamine session already, this session will take place the day following the initial session, or at least four half-lives after the first session.
干预措施: Placebo (Drug)
结局指标
主要结局
Memory-related changes in brain electrical activity in participants from baseline at Day 1 post-intervention (approx. within 1-3 hrs)
时间窗: Baseline, at Day 1 post-intervention (approx. within 1-3 hrs)
Memory-related changes in brain electrical activity in participants from baseline at post-intervention (approx. within 1-3 hrs) is measured by comparing the associative recognition memory tasks with the electrical readings collected across all bandwidths, but focusing on primarily theta changes.
Memory-related changes in brain electrical activity in participants from baseline at Day 2 post-intervention (approx. within 1-3 hrs)
时间窗: Baseline, at Day 2 post-intervention (approx. within 1-3 hrs)
Memory-related changes in brain electrical activity in participants from baseline at post-intervention (approx. within 1-3 hrs) is measured by comparing the associative recognition memory tasks with the electrical readings collected across all bandwidths, but focusing on primarily theta changes.
次要结局
未报告次要终点
研究者
Bradley Lega
ASSOC PROFESSOR - Neurological Surgery
University of Texas Southwestern Medical Center