A randomised controlled trial evaluating NeuRx/4 Diaphragm Pacing (DP) in patients with muscle weakness due to motor neurone disease/Amyotrophic Lateral Sclerosis

Sheffield Teaching Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 108 人开始时间: 2011年5月31日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Age 18 or older
•2. Familial or sporadic MND/ALS diagnosed as laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria
•3. Stabilised on Riluzole therapy
•4. Respiratory insufficiency as determined by one or more of:
•4.1. Forced Vital Capacity (FVC) less than 75% predicted/Sniff Nasal Inspiratory Pressure (SNIP) less than 40 cmH2O
•4.2. Supine vital capacity (VC) less than 75% of sitting or standing VC
•4.3. Partial pressure of carbon dioxide in the blood (PaCO2) > 6kPa (daytime)
•4.4. Significant overnight oxygen (O2) desaturation (>5% of night with Sp02 <90% during overnight oximetery)
•5. Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with diaphragm ultrasound or X-ray fluoroscopy
•6. Forced Vital Capacity (FVC) > 50% predicted or sniff nasal inspiratory pressure (SNIP) > 30 cmH2O in patients unable to perform FVC (bulbar patients)

•1. Prior NIV prescription
•2. Pre-existing implanted electrical device such as pacemaker or cardiac defibrillator
•3. Underlying cardiac, pulmonary diseases or other disorders that would affect pulmonary tests independently of MND/ALS or would increase the risk of general anaesthesia
•4. Current pregnancy or breastfeeding
•5. Significant decision making incapacity preventing informed consent by the subject due to a major mental disorder such as major depression or schizophrenia or dementia
•6. Marked obesity affecting surgical access to diaphragm or significant scoliosis/ chest wall deformity
•7. The involvement in any respiratory trial that can influence the safety or outcome measures of this study within three months of the planned implantation of the device or during the year of follow up
•8. Pre-existing diaphragm abnormality such as a hiatus hernia or paraoesophageal hernia of abdominal contents ascending into the thoracic cavity

发起方

Sheffield Teaching Hospitals NHS Foundation Trust (UK)