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临床试验/NCT04437056
NCT04437056Enrolling By Invitation不适用

Outcome Measurements After Cognitive Nerve Transfers to Spastic Muscles in Stroke Patients

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
20
试验地点
2
主要终点
Chedoke Arm and Hand Activity Inventory (CAHAI-9) score

研究概览

简要总结

Stroke is nowadays a leading cause of disability with devastating sequelae. Upper limb spasticity is one of them. Nevertheless, not all the muscles are equally affected, as some may turn spastic or paretic and other remain intact. This unique pathophysiological mosaic dictates a precise therapeutic plan. Existing spasticity treatment has significant drawbacks due to its unspecific targeting and short duration. A causal, life-lasting treatment, precisely adapted to every single patient's needs and to disease pattern, is currently missing. Hyperselective muscle denervation and subsequent cognitive reinnervation with appropriate unaffected donor nerves may break the pathological spastic circuit and provide volitional muscle control. With this pioneering study we will perform cognitive nerve transfers to spastic muscles and will prospectively investigate their effects on clinical, electrophysiological, molecular-biological and histological level. Accurate donor nerve selection will be for the first time quantified through motor unit number estimation with high-density needle electromyography. This revolutionary concept can open the window to a new era of therapeutic possibilities for stroke victims.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Are undergoing nerve transfers
  • Age from 18 to 75 years old
  • Minimum of 1 year interval after stroke
  • Are able to understand German or English
  • Medical Research Council (MRC) Muscle scale for donor nerves: M4 or M5
  • Walking patients, with or without crutches
  • Good general health condition and social support
  • For the control group:
  • Age 18-75 years old
  • Indication for ulnar nerve release and submuscular transposition for compression neuropathy in the elbow
  • No other neurological disorders

排除标准

  • Stroke earlier than 3 years at the time of first consultation
  • Lower limb spasticity and patients mobile with wheel chair

结局指标

主要结局

Chedoke Arm and Hand Activity Inventory (CAHAI-9) score

时间窗: 0-24 months

Patients can reach a score for CAHAI 9 between 9 to 63. The lower the score, the greater impairment.

Changes in electrophysiological muscle activity after nerve transfers

时间窗: 0-24 months

Low frequency-dependent depression of H-wave (in mV)

Modified Ashworth Scale

时间窗: 0-24 months

A score of 1 indicates no resistance, and 5 indicates rigidity. A 1+ scoring category indicates resistance through less than half of the movement. Scores range from 0-4, with 6 choices .

次要结局

  • The Action Research Arm Test (ARAT)(0-24 months)
  • The Disabilities of the Arm, Shoulder and Hand (DASH) score(0-24 months)
  • Changes in muscle satellite cell population (%) in spastic muscles and comparison with healthy control group(During surgery- 24 months)
  • Changes in sarcomere length (μm) in spastic muscles(During surgery- 12 months)
  • Motor Unit Number Estimation of donor and spastic muscles(0-24 months)
  • Comparison of collagen content between spastic and healthy muscles(During surgery- 12 months)

研究者

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

Olga Politikou

MD, Principal Investigator, PhD Student Clinical Laboratory for Bionic Extremity Reconstruction

Medical University of Vienna

研究点 (2)

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