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临床试验/NCT02089776
NCT02089776终止不适用

Real-time fMRI Neurofeedback for Motor Rehabilitation

National Institute of Neurological Disorders and Stroke (NINDS)1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2014年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
7
试验地点
1
主要终点
Change in neural functional connectivity as measured by fMRI.

研究概览

简要总结

Background:

  • People can learn to use feedback about brain activity to change that activity. Researchers want to see if people who have had a stroke can change their brain activity by practice and thought with feedback, and if that improves motor control. They will study brain activity in people who have and have not had strokes.

Objectives:

  • To see if people with stroke can change their brain activity and improve motor control by practice and thought.

Eligibility:

  • Adults 18 80 years old who have had a stroke.
  • Healthy volunteers 18 80 years old.

Design:

  • Participants will be screened with a medical history, MRI, and physical exam. For MRI, a magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a cylinder. They will be in the scanner less than 2 hours, lying still for up to 15 minutes at a time. The scanner makes loud noises. Participants will get earplugs.
  • Participants will have up to 3 scanning visits and up to 3 follow-up visits within 24 weeks. Visits may include screening, MRI, functional MRI (fMRI), questionnaires, and simple motor tests. Stroke participants may take additional motor tests, including transcranial magnetic stimulation (TMS).
  • fMRI: During this MRI, small metal disks may be taped to the skin or a fabric glove with small wires in it may be used to monitor hand movements. Heart rate and breathing may also be monitored. Participants may be monitored by video and asked to perform tasks.
  • TMS: A brief electrical current goes through a coil on the scalp. It creates a magnetic pulse that stimulates the brain. Participants may be asked to perform simple actions. Finger or hand movements may be recorded.

详细描述

Objective:

The objective of this study is to understand whether healthy volunteers and patients with chronic stroke resulting in hemiparesis can learn how to modulate their brain activity using feedback during real-time functional magnetic resonance imaging (rtfMRI), and whether such feedback training can lead to improvement in motor rehabilitation in chronic stroke patients.

Study population:

This study will be carried out in two parallel phases. In Phase 1, we will study learning to control brain functional activation (feedback technique using rtfMRI) in adult healthy volunteers; in Phase 2, we will study adult patients with chronic stroke. In both phases, we intend to study whether feedback training with rtfMRI leads to increased control of brain activity and whether this correlates with improvements in motor control in healthy participants and improvement in motor function, in chronic stroke patients, both immediately after training and at later time points. The reason for carrying out this study in parallel is that, as stated recently by Dr Petra Kaufman during a PIRC meeting, patients with brain lesions may benefit from this approach even if healthy volunteers do not.

Design:

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older 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

Change in neural functional connectivity as measured by fMRI.

时间窗: Immediately after intervention; up to 6 months post-intervention

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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