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临床试验/NCT01659541
NCT01659541已完成不适用

Spinal Cord Stimulation With Wire Leads to Restore Cough

MetroHealth Medical Center2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.

研究概览

简要总结

The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire leads, to produce an effective cough in patients with spinal cord injuries.

详细描述

Patients with cervical spinal cord injuries often have paralysis of a major portion of their expiratory muscles - the muscles responsible for coughing - and therefore, lack a normal cough mechanism. Consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to the development of recurrent respiratory tract infections such as pneumonia and bronchitis. Expiratory muscles can be activated by electrical stimulation of the spinal roots to produce a functionally effective cough.

The purpose of this trial is to determine if electrical stimulation of the expiratory muscles by wire leads is capable of producing an effective cough on demand. According to the trial researchers, if successful, this technique will prevent the need for frequent patient suctioning - which often requires the constant presence of trained personnel. It will also allow spinal cord injured patients to clear their secretions more readily, thereby reducing the incidence of respiratory complications and associated illness and death.

In the trial, researchers will study 16 adults (18-75 years old) with cervical spinal injuries (C8 level or higher), at least 6 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have wire leads placed - by a routine, minimally invasive surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.

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

  • Spinal cord injury C8 level or higher
  • 12 months post-injury (if the American Spinal Injury Association (ASIA) Impairment Scale (AIS) incomplete) or 6 months post-injury (if AIS complete)
  • Expiratory muscle weakness
  • Between 18 and 75 years of age
  • Adequate oxygenation

排除标准

  • Untreated lung, cardiovascular or brain disease
  • Scoliosis, chest wall deformity, or marked obesity
  • Unmanaged hypertension (high blood pressure) or hypotension (low blood pressure)
  • Low oxygenation
  • Minor infection at the site of implantation requiring antibiotics within the past 3 weeks
  • Serious infection requiring hospitalization within the past 6 weeks

结局指标

主要结局

Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.

时间窗: 52 weeks (1 year)

Peak Expiratory airflow rate is a person's maximum speed of expiration. Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration. It was measured after release of airway occlusion after peak airway pressure was achieved.

Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough

时间窗: 52 weeks (1 year)

Maximum expiratory pressure is the highest pressure that can be developed during a forceful expiratory effort against an occluded airway.

次要结局

  • Secretion Management Episodes(52 weeks (1 year))
  • Difficulty Raising Sputum(52 weeks (1 year))
  • Life Quality Assessment -Stress Level(52 weeks (1 year))
  • Number of Respiratory Tract Infections(52 weeks (1 year))

研究者

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

Anthony F. Dimarco

Professor

MetroHealth Medical Center

研究点 (2)

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