Abdominal Functional Electrical Stimulation in Tetraplegia
Primary Purpose
Tetraplegia, Spinal Cord Injury
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Surface Functional Electrical Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Tetraplegia focused on measuring tetraplegia, quadriplegia, spinal cord injury, functional electrical stimulation, abdominal stimulation
Eligibility Criteria
Inclusion Criteria: cervical spinal cord injury Exclusion Criteria: subject must not be ventilator-dependent
Sites / Locations
- Queen Elizabeth National Spinal Injuries Unit
Outcomes
Primary Outcome Measures
Tidal Volume
Peak Expiratory Flow
Secondary Outcome Measures
Expired CO2 levels
Vital Capacity
Full Information
NCT ID
NCT00202631
First Posted
September 12, 2005
Last Updated
November 24, 2006
Sponsor
South Glasgow University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT00202631
Brief Title
Abdominal Functional Electrical Stimulation in Tetraplegia
Official Title
Abdominal Functional Electrical Stimulation to Augment Breathing in Tetraplegia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
South Glasgow University Hospitals NHS Trust
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetraplegia, Spinal Cord Injury
Keywords
tetraplegia, quadriplegia, spinal cord injury, functional electrical stimulation, abdominal stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Surface Functional Electrical Stimulation
Primary Outcome Measure Information:
Title
Tidal Volume
Title
Peak Expiratory Flow
Secondary Outcome Measure Information:
Title
Expired CO2 levels
Title
Vital Capacity
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cervical spinal cord injury
Exclusion Criteria:
subject must not be ventilator-dependent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan N McLean, MRCP
Organizational Affiliation
Queen Elizabeth National Spinal Injuries Unit, Glasgow
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth J Hunt, BSc, PhD, DSc
Organizational Affiliation
Department of Mechanical Engineering, University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth National Spinal Injuries Unit
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G51 4TF
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
10779105
Citation
Stanic U, Kandare F, Jaeger R, Sorli J. Functional electrical stimulation of abdominal muscles to augment tidal volume in spinal cord injury. IEEE Trans Rehabil Eng. 2000 Mar;8(1):30-4. doi: 10.1109/86.830946.
Results Reference
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Abdominal Functional Electrical Stimulation in Tetraplegia
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