Abdominal Functional Electrical Stimulation in Tetraplegia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by South Glasgow University Hospitals NHS Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
South Glasgow University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00202631
First received: September 12, 2005
Last updated: November 24, 2006
Last verified: November 2006
  Purpose

People with high spinal lesions are at risk of respiratory complications because they have partial or complete paralysis of breathing muscles. Previous work has shown that tetraplegic lung volumes can be increased by using abdominal FES during expiration. The technique is attractive because it is non-invasive, painless in tetraplegia and completely reversible. It may provide a treatment for augmenting the patient’s breathing both in the acute presentation of spinal injury (when half of cervical injuries require ventilation) and in long term management of tetraplegia and high paraplegia. We propose a pilot study in a small group of subjects to see if the technique is feasible from both a clinical and engineering viewpoint. The aims of the study are: 1)To examine the effects of abdominal FES on lung mechanics and gas exchange in tetraplegic subjects. 2)To optimise the stimulation pattern and intensity via electronic stimulators and to design a trigger to allow the FES to follow the subject’s own breathing cycle automatically.


Condition Intervention
Tetraplegia
Spinal Cord Injury
Device: Surface Functional Electrical Stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Abdominal Functional Electrical Stimulation to Augment Breathing in Tetraplegia

Resource links provided by NLM:


Further study details as provided by South Glasgow University Hospitals NHS Trust:

Primary Outcome Measures:
  • Tidal Volume
  • Peak Expiratory Flow

Secondary Outcome Measures:
  • Expired CO2 levels
  • Vital Capacity

Estimated Enrollment: 4
Study Start Date: June 2002
Estimated Study Completion Date: November 2006
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cervical spinal cord injury

Exclusion Criteria:

  • subject must not be ventilator-dependent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00202631

Locations
United Kingdom
Queen Elizabeth National Spinal Injuries Unit
Glasgow, Lanarkshire, United Kingdom, G51 4TF
Sponsors and Collaborators
South Glasgow University Hospitals NHS Trust
Investigators
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00202631     History of Changes
Other Study ID Numbers: AbdomGlasgow
Study First Received: September 12, 2005
Last Updated: November 24, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by South Glasgow University Hospitals NHS Trust:
tetraplegia
quadriplegia
spinal cord injury
functional electrical stimulation
abdominal stimulation

Additional relevant MeSH terms:
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014