跳至主要内容
临床试验/NCT05406349
NCT05406349招募中不适用

Neural Mechanisms of Spatial Representations Beyond the Self

Boston University Charles River Campus1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年8月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Oscillatory frequency

研究概览

简要总结

Spatial navigation is a fundamental human behavior, and deficits in navigational functions are among the hallmark symptoms of severe neurological disorders such as Alzheimer's disease. Understanding how the human brain processes and encodes spatial information is thus of critical importance for the development of therapies for affected patients. Previous studies have shown that the brain forms neural representations of spatial information, via spatially-tuned activity of single neurons (e.g., place cells, grid cells, or head direction cells), and by the coordinated oscillatory activity of cell populations. The vast majority of these studies have focused on the encoding of self-related spatial information, such as one's own location, orientation, and movements. However, everyday tasks in social settings require the encoding of spatial information not only for oneself, but also for other people in the environment. At present, it is largely unknown how the human brain accomplishes this important function, and how aspects of human cognition may affect these spatial encoding mechanisms. This project therefore aims to elucidate the neural mechanisms that underlie the encoding of spatial information and awareness of others. Specifically, the proposed research plan will determine how human deep brain oscillations and single-neuron activity allow us to keep track of other individuals as they move through our environment. Next, the project will determine whether these spatial encoding mechanisms are specific to the encoding of another person, or whether they can be used more flexibly to support the encoding of moving inanimate objects and even more abstract cognitive functions such as imagined navigation. Finally, the project will determine how spatial information is encoded in more complex real-world scenarios, when multiple information sources (e.g., multiple people) are present. To address these questions, intracranial medial temporal lobe activity will be recorded from two rare participant groups: (1) Participants with permanently implanted depth electrodes for the treatment of focal epilepsy through responsive neurostimulation (RNS), who provide a unique opportunity to record deep brain oscillations during free movement and naturalistic behavior; and (2) hospitalized epilepsy patients with temporarily implanted intracranial electrodes in the epilepsy monitoring unit (EMU), from whom joint oscillatory and single-neuron activity can be recorded.

详细描述

This research study is based upon a unique opportunity to work with neurosurgical patients, who already have electrodes implanted in deep brain structures for clinical reasons (i.e., for the monitoring and treatment of pharmaco-resistant epilepsy). Research procedures will only be performed with patients who already have such electrodes implanted for clinical reasons; no electrodes will be implanted for research purposes, and the researchers will not have any influence on the implantation procedures of these electrodes. Two groups of participants will be asked to participate in the research study: 1. Hospitalized patients who have electrodes implanted temporarily (typically for up to two weeks) for epilepsy monitoring in the epilepsy monitoring unit (EMU participants). 2. Patients who have chronically/permanently implanted electrodes as part of the NeuroPace RNS System for the treatment of epilepsy (RNS participants). Independent from and prior to the research study, the patient's clinical care team (neurologists, neurosurgeons, etc.) decide whether electrodes or the RNS System will be implanted based solely on clinical criteria. If electrodes or the RNS System are implanted, patients will then be offered to participate in the research study; however, the decision whether or not to participate in the research study will not have any effect on the patient's treatment or clinical care.

Screening, recruitment, and consent procedures for EMU participants:

If the clinical care team decides - independent from the research study - that a patient's clinical condition merits implantation of temporary electrodes and hospitalization in the epilepsy monitoring unit (EMU), the patient's neurologists or neurosurgeons will invite the patient to participate in the research study. The neurosurgeons and neurologists make it clear to the patient that the decision to participate in the research is entirely voluntary and that the patient's medical needs will not be affected in any way by this decision. For patients who are interested in participating in the research study, the principal investigators meet with the patient to discuss the consent form. Subsequently the principal investigator also ensures that the patient fully understands the consent form and emphasizes again to the patient that participation is entirely voluntary and that the patient's decision whether to participate or not will have no effect on their medical care. If the patients are local, the research team meets with the patient at UCLA before or after pre-surgical tests. This is commonly done a 1-3 weeks before the surgery. For patients traveling long distance, the discussion may take place the day before the surgery. After discussion the patient signs the consent form to participate in the research study and it is countersigned by the principal investigator.

Screening, recruitment, and consent procedures for RNS participants:

For the proposed study, the investigators have already identified a number of patients for other ongoing studies that received NeuroPace RNS System at the UCLA medical center with RNS devices implanted in medial temporal lobe regions. These patients have been identified through their neurosurgeon or neurologist, who are part of the study team. These neurosurgeons and neurologists will inform their patients about the opportunity to participate in this research study. The neurosurgeons and neurologists make it clear to the patient that the decision to participate in the research is entirely voluntary and that the patient's medical needs will not be affected in any way by this decision. Potential subjects external to the UCLA medical center may have preliminary contact from their treating physician from a referring institution. If patients indicate interest in the study, the principal investigator, faculty sponsor, or the study coordinator will make initial direct contact via phone in a private secure location to introduce and describe the study after which further information and copy of consent form can be sent for review via secure encrypted e-mail and/or mail, if necessary. The principal investigators also ensure that the patient fully understands the consent form and emphasize again that participation is entirely voluntary and that the patient's decision whether to participate will have no effect on their medical care. Potential participants will be approached no earlier than 3 months after their RNS system placement to see if the patient would be interested in volunteering for the study. Consent may be obtained over the phone or internet for participants necessitating extended travel arrangements and accommodations. Participants, particularly those consented over the phone or via the internet, will be provided with a physical copy of the consent form and asked to sign it before performing any research procedures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between 18 and 70 years of age
  • Adequate visual and auditory acuity to allow neuropsychological testing
  • Have undergone depth electrode placement for the purpose of epilepsy evaluation/treatment OR have NeuroPace RNS System implanted for epilepsy treatment

排除标准

  • All DSM-V Axis I and II disorders other than nicotine-dependence
  • History of brain damage

研究组 & 干预措施

Electrophysiological recordings in participants with intracranially implanted electrodes

Other

All participants will perform behavioral tasks that test their spatial navigation and memory performance in self-navigation and observation tasks.

干预措施: Self-navigation task (Behavioral)

Electrophysiological recordings in participants with intracranially implanted electrodes

Other

All participants will perform behavioral tasks that test their spatial navigation and memory performance in self-navigation and observation tasks.

干预措施: Observation task (Behavioral)

结局指标

主要结局

Oscillatory frequency

时间窗: Continuous measurement during task performance on day 1 and all subsequent measurement days (up to 14 days per participant)

It will be measured how the frequency of an oscillation (measurement unit: Hertz), as measured via intracranially implanted electrodes and an electroencephalography recording system, is modulated by task-related behavioral variables (such as the individual's spatial location, head direction, movement speed, or their distance/direction to environmental boundaries).

Oscillatory power

时间窗: Continuous measurement during task performance on day 1 and all subsequent measurement days (up to 14 days per participant)

It will be measured how the oscillatory power (measurement unit: microvolts-squared) of electrophysiological brain activity, as measured via intracranially implanted electrodes and an electroencephalography recording system, is modulated by task-related behavioral variables (such as the individual's spatial location, head direction, movement speed, or their distance/direction to environmental boundaries).

Oscillatory amplitude

时间窗: Continuous measurement during task performance on day 1 and all subsequent measurement days (up to 14 days per participant)

It will be measured how the oscillatory amplitude (measurement unit: microvolts) of electrophysiological brain activity, as measured via intracranially implanted electrodes and an electroencephalography recording system, is modulated by task-related behavioral variables (such as the individual's spatial location, head direction, movement speed, or their distance/direction to environmental boundaries).

Firing rate of single neurons

时间窗: Continuous measurement during task performance on day 1 and all subsequent measurement days (up to 14 days per participant)

It will be measured how the firing rate of single neurons (measurement unit: Hertz), as measured via intracranially implanted micro-electrodes and an electrophysiology recording system, is modulated by task-related behavioral variables (such as the individual's spatial location, head direction, movement speed, or their distance/direction to environmental boundaries).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Matthias Stangl

Principal Investigator

Boston University

研究点 (1)

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