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临床试验/NCT05086055
NCT05086055招募中不适用

Training the Surviving Neural Network to Create New Synaptic Connections That Can Maximize Restoration of Motor Functions After Stroke

Norwegian University of Science and Technology3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
3
主要终点
Changes in inflammatory activity in brain

研究概览

简要总结

Multimodal imaging of stroke patients. Patients included in the study will be investigated with multiparametric imaging tools including MRI and EEG imaging. Improvements in motor skills will be monitored clinically.

详细描述

We aim to (i) quantify the size of the brain lesion and assess the surviving functional neural network connections; (ii) Analyze the type and degree of inflammation initiated by the stroke-induced brain lesion. We will stratify inflammation according to lesion volume, surviving functional neural network connections, age, NIHSS and Modified Rankin Scale (mRS) and analyze how inflammation markers change during rehabilitation; (iii) Train the surviving neural network to create new synaptic connections that can maximize restoration of motor functions; (iv) Apply and develop advanced mathematical and computational methods to model and predict how stroke rehabilitation can rewire the neural network connections to best facilitate restoration of lost motor function.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • subcortical strokes resulting in arm motor deficits.
  • admitted to the stroke unit, St Olav´s Hospital during 2021-2023

排除标准

  • Previous stroke
  • neurodegenerative disease
  • brain tumors
  • previous neurotrauma or brain operation
  • cognitive dysfunction and claustrophobia preventing MRI examinations.

结局指标

主要结局

Changes in inflammatory activity in brain

时间窗: 6 months

Markers of post-stroke inflammation will be measured in pg/ml and ng/ml.

Changes in brain volume

时间窗: 6 months

Stroke induced brain volume changes (mm3) will be measured using magnetic resonance imaging (MRI) at 1 day and 6 months post-stroke.

Stroke induced changes in brain activity.

时间窗: 6 months

Document longitudinal changes in brain activity using EEG. Changes will be measured in cycles/second (Hertz, Hz).

muscle function

时间窗: 6 months

Longitudinal kinematic profiling. Electromyography measurements of muscle function post-stroke will be measured in cycles/second (Hz) and amplitude (mm). Extension and flexion of arm will be measured in cm. Joint angles will be measured in degrees. Speed of flexion and extension will be measured in cm/second

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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