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临床试验/NCT00116337
NCT00116337已完成不适用

Spinal Cord Stimulation to Restore Cough

MetroHealth Medical Center2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2004年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough.

研究概览

简要总结

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

详细描述

Patients with cervical and thoracic 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 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 18 adults (18-70 years old) with spinal injuries (T5 level or higher), at least 12 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have small electrodes (metal discs) placed - by a routine 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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stable spinal cord injury T5 level or higher
  • Expiratory muscle weakness

排除标准

  • Significant cardiovascular disease
  • Active lung disease
  • Brain disease
  • Scoliosis, chest wall deformity, or marked obesity

结局指标

主要结局

Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough.

时间窗: baseline (pre-implant) and 1 year follow up (post-implant)

Peak airflow achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).

Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough.

时间窗: baseline (pre-implant) and 1 year follow up (post-implant)

Airway pressure generation achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).

次要结局

  • Incident of Acute Respiratory Tract Infections(baseline (pre-implant) and 1 year follow up (post-implant))
  • Trained Caregiver Support for Secretion Clearance(baseline (pre-implant) and 1 year follow up (post-implant))

研究者

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

Anthony F. Dimarco

Professor of Medicine

MetroHealth Medical Center

研究点 (2)

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