Abdominal Functional Electrical Stimulation in Tetraplegia
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedNovember 28, 2006
November 1, 2006
September 12, 2005
November 24, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Tidal Volume
Peak Expiratory Flow
Secondary Outcomes (2)
Expired CO2 levels
Vital Capacity
Interventions
Eligibility Criteria
You may qualify if:
- cervical spinal cord injury
You may not qualify if:
- subject must not be ventilator-dependent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Elizabeth National Spinal Injuries Unit
Glasgow, Lanarkshire, G51 4TF, United Kingdom
Related Publications (1)
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.
PMID: 10779105BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
June 1, 2002
Study Completion
November 1, 2006
Last Updated
November 28, 2006
Record last verified: 2006-11