Abdominal Functional Electrical Stimulation in Tetraplegia
|ClinicalTrials.gov Identifier: NCT00202631|
Recruitment Status : Unknown
Verified November 2006 by South Glasgow University Hospitals NHS Trust.
Recruitment status was: Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : November 28, 2006
|Condition or disease||Intervention/treatment||Phase|
|Tetraplegia Spinal Cord Injury||Device: Surface Functional Electrical Stimulation||Not Applicable|
Patients with high spinal cord injury (SCI) usually have paralysed intercostal muscles and rely on diaphragm function alone for respiration. They have low tidal volumes and inadequate cough. These patients are vulnerable to respiratory complications in the immediate post-injury phase and remain at life-long risk of chest problems. Usual treatments include intensive physiotherapy and intermittent positive pressure ventilation to augment the patient’s tidal volume and to help clear excess secretions.
Tidal volumes can also be increased by electrical stimulation of the surface of abdominal muscles during expiration. During stimulation the patient expires below functional residual capacity (the amount of air left after normal expiration). The natural elasticity of the chest wall then causes a recoil increase in the size of the next inspired breath. Functional electrical stimulation (FES) of the abdominal muscles is theoretically an attractive technique to augment respiration. It is non-invasive, it mimics natural physiological processes and tetraplegic patients cannot sense abdominal discomfort. There are potential applications in acute SCI patients to prevent the need for artificial ventilation and to aid ventilator weaning. The technique could also be used in chronically injured patients to augment ventilation.
Clinical staff at the Queen Elizabeth National Spinal Injuries Unit have collaborated extensively with engineering and bioengineering teams from Glasgow University and the University of Strathclyde in the use of FES in SCI. FES is already being used successfully in the Unit for paraplegic cycling and upper limb exercise in tetraplegia. We have performed abdominal FES on one SCI subject with complete diaphragm paralysis and produced a tidal volume of one hundred millilitres (McLean and Hunt, unpublished observation).
Before starting a large scale project it is important to confirm whether we can reliably reproduce at least some of the findings of Stanic et al. It would be very interesting if we could show any change in gas exchange as well as simply increasing tidal volume. Engineering issues include optimisation and programming of the FES stimulus. We propose a pilot study in QENSIU to establish whether the technique is of practical benefit to spinal cord injured patients.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Abdominal Functional Electrical Stimulation to Augment Breathing in Tetraplegia|
|Study Start Date :||June 2002|
|Study Completion Date :||November 2006|
- Tidal Volume
- Peak Expiratory Flow
- Expired CO2 levels
- Vital Capacity
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202631
|Queen Elizabeth National Spinal Injuries Unit|
|Glasgow, Lanarkshire, United Kingdom, G51 4TF|
|Principal Investigator:||Alan N McLean, MRCP||Queen Elizabeth National Spinal Injuries Unit, Glasgow|
|Principal Investigator:||Kenneth J Hunt, BSc, PhD, DSc||Department of Mechanical Engineering, University of Glasgow|