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临床试验/NCT03592173
NCT03592173进行中(未招募)2 期

Non-Invasive Stimulation for Improving Motor Function in Spinal Cord Injury

Kathleen Friel2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年7月1日最近更新:
适应症

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
30
试验地点
2
主要终点
Change in H-Reflex Threshold

研究概览

简要总结

The purpose of this study is to determine if spinal excitability is increased with a Spinal Associative Stimulation (SAS) protocol, and to determine the functional consequences of this technique on motor recovery.

详细描述

Recovery of motor function continues to be a problem following Spinal Cord Injury. Non-invasive brain stimulation techniques, targeting cortical areas, have been shown to enhance the excitability in the human motor cortex, and these changes in the motor cortex may be of significance for the rehabilitation of brain injured patients. However, little is known about the adaptational changes in the excitability/plasticity of spinal neural circuits in spinal cord injury patients.

The purpose of this study is to investigate the excitability of cortical and spinal inhibitory and excitatory mechanisms before and following a period of repetitive and synchronized dual peripheral nerve and brain stimulation. Repetitive, paired brain and peripheral nerve stimulation as a neuromodulatory tool, paired associative stimulation (PAS), has been well described. In this technique, stimuli are timed such that afferent and efferent volleys interact at the level of the cortex, that lead to a temporary enhancement of Motor Evoked Potential (MEP) amplitude in target muscles, and when applied repeatedly, lead to a sustained effect, outlasting the intervention period. This repetitive technique has been done in healthy subjects and patients with neurological diseases. By modifying the time between paired stimuli, the investigators will generate afferent/efferent interactions in the spinal cord.

The working hypothesis of this study is that the acute facilitation of the H-reflex during Paired TMS and peripheral nerve stimulation, may be harnessed to modulate spinal excitability (sustained increase in the MEP amplitude). That is, the investigators will test if similar to PAS, a change in excitability outlasting the stimulation/intervention period may occur with afferent/efferent interactions, although at the level of the spinal cord rather than the cortex, and be useful to strengthen residual pathways after damage to the spinal cord.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

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

  • Spinal cord injury subjects with chronic lesions (> 6 months after the injury)
  • Motor incomplete lesion, measured by the American Spinal cord Injury Association (ASIA) Impairment Scale (AIS)
  • Traumatic cause of lesion; d) Some degree of motor function in the ankle flexor and extensors (Low extremity Motor Score - LEMS≥3).

排除标准

  • Motor and sensory complete lesion (AIS A); LEMS < 3;
  • Non-traumatic cause of lesion
  • Medically unstable condition
  • Other concurrent neurological illness
  • Presence of a potential TMS risk factor (detailed below)
  • Potential TMS risk factor:
  • Damaged skin at the site of stimulation
  • Presence of an electrically, magnetically or mechanically activated implant
  • An intracerebral vascular clip, or any other electrically sensitive support system
  • Metal in any part of the body, including metal injury to the eye
  • A history of medication-resistant epilepsy in the family
  • Past history of seizures or unexplained spells of loss of consciousness.

结局指标

主要结局

Change in H-Reflex Threshold

时间窗: Baseline compared with immediately after intervention

Assessment of muscle reaction after stimulation of sensory fibers

次要结局

  • Walking Index for Spinal Cord Injury (WISCI II)(Baseline, immediately after intervention)
  • Muscle Force(Baseline, immediately after intervention)
  • Anklebot(Baseline, immediately after intervention)
  • Lower Extremity Motor Score (LEMS)(Baseline, immediately after intervention)
  • Spinal Cord Independence Measure, Version 3 (SCIM III)(Baseline, immediately after intervention)
  • 10 Meter Walk Test(Baseline, immediately after intervention)

研究者

发起方
Kathleen Friel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kathleen Friel

Laboratory Director

Burke Medical Research Institute

研究点 (2)

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