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临床试验/NCT02865317
NCT02865317Unknown不适用

Investigating the Long-Term Cortical Effects of Peripheral Nerve Injury At Birth

Gazi University0 个研究点目标入组 15 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
主要终点
voxels

研究概览

简要总结

Cortical activity during rest and with stimulation by functional magnetic resonance imaging will be investigated in patients with OBPI.

详细描述

Peripheral nerve injury results in a number of cortical changes due to the lack of sensory and motor stimuli. Although functional magnetic resonance imaging (fMRI) studies that revealed the changes in the cortical activation exist, the cortical activation changes in obstetrical brachial plexus injury is poorly known. For this reason, the aim of this study is to investigate the cortical activity during rest and with stimulation by fMRI in patients with OBPI.

Patients with OBPI diagnosis in the cervical 5-6 (C5-6) (upper trunk) who are followed up in Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation Division of Hand Rehabilitation will participate in the study. Patients with a surgery history at least 5 years ago and over 10 years age will be included. Clinical motor and sensory assessments will be performed to help in explaining the analyses of cortical activation. In their first visit, clinical assessments including Active Movement Scale, modified Mallet Classification (MMC) and sensory tests will be performed; while fMRI scanning will be carried out in the second visit. Patients will be scanned for 3 paradigms at one single fMRI session: at rest and during sensory stimulation and watching videos of motor movements. Video images will include the 5 movements used in MMC and will be watched by glasses integrated in the MRI device. Images obtained from MR scanning will be analyzed with analysis programs like Leonardo, Fresurfer, SPM, BrainVoyager and clinical results will be compared to MR images.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
10 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • upper trunk (cervical 5-6) involvement
  • cooperated

排除标准

  • illiterate
  • surgical history for his arm in the previous 5 years
  • other than only C5-6 involvement
  • any impairment that prevents positioning in MRI machine

结局指标

主要结局

voxels

时间窗: 6 months

voxels (n) are the task-activated volume of brain regions

次要结局

  • Active Movement Scale score(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeynep Tuna

Principal Investigator

Gazi University

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Cortical Effects of Peripheral Nerve Injury At Birth | 临床试验