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临床试验/NCT01194661
NCT01194661已完成不适用

Neural Dynamics and Connectivity in Response Inhibition and Traumatic Brain Injury

National Institute of Neurological Disorders and Stroke (NINDS)1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2010年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
1
主要终点
TMS effects on behavioral performance

研究概览

简要总结

Background:

  • Previous research has shown that certain parts of the brain are involved in voluntarily stopping an ongoing motor response (movement); however, it is not known whether this same network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can significantly impair the brain's ability to voluntarily stop or inhibit certain actions. Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation (transcranial magnetic stimulation, or TMS) to investigate how people perform activities that involve moving and suppressing movements, researchers hope to better understand how these brain areas might be affected in people who have had TBI.

Objectives:

  • To determine the parts of the brain involved in suppressing an urge to act.
  • To determine the extent to which traumatic brain injury affecting certain parts of the brain is involved in problems with suppressing an urge to move and stopping movement.

Eligibility:

  • Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy volunteers.

Design:

  • This research study includes a screening visit and two study visits, each of which will last at least 2 hours.
  • Participants will be screened with a physical examination and medical history. Women who can become pregnant will have a urine pregnancy test before being allowed to participate in the study.
  • At the first study visit, participants will complete one of the following experiment tests in an MRI scanner.
  • Experiment 1: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will practice the experiment tasks before performing them during MRI scans.
  • Experiment 2: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will also have TMS while at rest, and will perform the experiment tasks during the MRI scan.
  • At the second study visit, participants will have an fMRI scan where they will be asked to do simple response tasks with a computer outside the MRI scanner.

Background:

  • Previous research has shown that certain parts of the brain are involved in voluntarily stopping an ongoing motor response (movement); however, it is not known whether this same network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can significantly impair the brain's ability to voluntarily stop or inhibit certain actions. Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation (transcranial magnetic stimulation, or TMS) to investigate how people perform activities that involve moving and suppressing movements, researchers hope to better understand how these brain areas might be affected in people who have had TBI.

Objectives:

  • To determine the parts of the brain involved in suppressing an urge to act.
  • To determine the extent to which traumatic brain injury affecting certain parts of the brain is involved in problems with suppressing an urge to move and stopping movement.

Eligibility:

  • Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy volunteers.

Design:

  • This research study includes a screening visit and two study visits, each of which will last at least 2 hours.
  • Participants will be screened with a physical examination and medical history. Women who can become pregnant will have a urine pregnancy test before being allowed to participate in the study.
  • At the first study visit, participants will complete one of the following experiment tests in an MRI scanner.
  • Experiment 1: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will practice the experiment tasks before performing them during MRI scans.
  • Experiment 2: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will also have TMS while at rest, and will perform the experiment tasks during the MRI scan.
  • At the second study visit, participants will have an fMRI scan where they will be asked to do simple response tasks with a computer outside the MRI scanner.

详细描述

Objectives

Voluntarily stopping an on-going motor response has been shown to engage a specific prefrontal-basal-ganglia (PBG) neural network. However, it is not known whether the PBG network is also crucial for other types of response inhibition such as suppressing an urge to act (i.e., habitual impulse), a common impairment after traumatic brain injury (TBI). The objectives of this protocol are: 1) to determine whether the PBG network is engaged in suppressing habitual impulses and, 2) to determine the extent to which the (PBG) neural network can account for the deficiency in response inhibition after mild to moderate traumatic brain injury (TBI). The proposed studies will involve performance of simple behavioral tasks, functional magnetic resonance imaging (fMRI), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and diffusion tensor imaging (DTI). tDCS will be applied separately from fMRI scans. TMS will be applied separately or concurrently during fMRI scans.

Study Population

One hundred and ninety healthy adult volunteers and 95 patients with mild to moderate TBI will be recruited under the protocol. Eighty of the healthy volunteers and 80 of the patients will be recruited under the project funded by the Center for Neuroscience and Rehabilitative Medicine (CNRM) at the Uniformed Services University of the Health Sciences (USUHS).

Design

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

TMS effects on behavioral performance

时间窗: Ongoing

Task-dependent and independent fMRI BOLD signal

时间窗: Ongoing

次要结局

  • White matter fiber integrity in TBI patients estimated by the degree of fractional anisotropy (FA) from diffusion tensor imaging (DTI) signals.(Ongoing)
  • Behavioral performance data (reaction time and accuracy)(Ongoing)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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