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Abdominal Functional Electrical Stimulation in Tetraplegia

NCT00202631 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2006-11-28

No results posted yet for this study

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.

Conditions

  • Tetraplegia
  • Spinal Cord Injury

Interventions

DEVICE

Surface Functional Electrical Stimulation

Sponsors & Collaborators

  • South Glasgow University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Alan N McLean, MRCP · Queen Elizabeth National Spinal Injuries Unit, Glasgow

  • Kenneth J Hunt, BSc, PhD, DSc · Department of Mechanical Engineering, University of Glasgow

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Completion
2006-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00202631 on ClinicalTrials.gov