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临床试验/NCT05207878
NCT05207878已完成不适用

Interhemispheric Communication and Compensation in Peripheral Nerve Injury

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年12月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
BOLD (blood oxygen level dependent) signal in ROIs (regions of interest)

研究概览

简要总结

The goal of this study is to determine which parts of the brain make it possible for some people to move skillfully with their left non-dominant hand.

详细描述

This is a one-visit study, in which right-handed participants (individuals with unilateral peripheral nerve injury to the right upper limb, and healthy controls) will complete surveys and perform movement tasks. Movement tasks will be performed inside and outside a magnetic resonance imaging (MRI) scanner.

Some participants will also receive transcranial magnetic stimulation (TMS) to briefly interfere with these putative brain networks.

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

盲法说明

During TMS, participants will be masked to whether they receive effective or sham stimulation on a given trial.

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

  • This study contains two groups: typical controls and patients. Participants will be matched by age and sex between the two groups. No randomization will occur.
  • A. Inclusion criteria (all participants):
  • English speaking and reading
  • Able to fit in Prisma scanner bore (60 cm diameter)
  • Right hand dominant (self report, and Edinburgh handedness ≥ +40)
  • B. Inclusion criteria (patients only):
  • Chronic unilateral upper extremity peripheral nerve injury to the right side
  • "Chronic" defined as ≥ 6 months since injury
  • "Upper extremity" defined as hand, arm, or shoulder (including e.g. brachial plexus)
  • "Injury" defined as localized cause (e.g. mechanical/tumor, not distributed pathology), including compression
  • Some impairment to writing, requiring both of:
  • Difficulty writing, as determined by score 2+ (Mild+) on "How much difficulty have you had in the last week with writing?" (From Disabilities of the Arm, Shoulder, and Hand survey question #2)
  • Box and Blocks motor performance ≥1 standard deviation below the mean of age-matched healthy adults (Mathiowetz et al. 1985, AJOT).

排除标准

  • (all participants)
  • Currently intoxicated or otherwise non-compliant
  • Chronic pain diagnosis unrelated to the nerve injury
  • Uncorrected visual impairment that interferes with ability to see drawings in MRI
  • Motor function diagnoses that affect function of the left hand, now or in past 2 years
  • Motor function diagnoses currently affecting the right hand, unrelated to the nerve injury
  • This is not meant to exclude a single event with complex consequences (e.g. nerve and tendon)
  • This is not meant to exclude multiple nerve injuries in the same arm, if each one is eligible (II.B.1)
  • This is meant to exclude e.g. injury and unrelated musculoskeletal disorder in same arm
  • Upper extremity surgery, including peripheral nerve surgery, within last 2 months
  • Contraindication for MRI
  • Contraindication for transcranial magnetic stimulation (TMS)
  • May exclude from TMS only (since not all participants undergo TMS), or exclude from full study
  • Amputation affecting any part of thumb, index, or middle fingers (including higher level, e.g. whole hand)
  • History of chronic cocaine use (based on medical record or volunteered; will not actively inquire)
  • Diagnosis of schizophrenia or other rare psychiatric disorder
  • This is not meant to exclude depression or anxiety
  • History of major neurological diagnosis, e.g. stroke, traumatic brain injury, Alzheimer's, Parkinson's
  • This is not meant to exclude concussion UNLESS < 6 months ago, or post-concussion syndrome (diagnosed or self-report)
  • D. Exclusion criteria (controls only)
  • 1. Motor function diagnoses that affect function of either hand, now or in past 2 years

研究组 & 干预措施

Movement task

Experimental

All participants perform the STEGA-MRI (standardized tracing evaluation & grapheme assessment - MRI) precision drawing task during fMRI scanning.

Motor assessments outside the MRI do not qualify as interventions.

干预措施: STEGA-MRI (Other)

结局指标

主要结局

BOLD (blood oxygen level dependent) signal in ROIs (regions of interest)

时间窗: Day 1

BOLD signal in key ROIs (primary motor and posterior parietal cortex). ROI selection may be revisited after preliminary data review (35 participants)

次要结局

  • Drawing smoothness(Day 1)
  • Hand choice(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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