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Understanding the mechanisms of Abdominal Functional Electrical Stimulation in patients with a spinal cord injury

Understanding the mechanisms of Abdominal Functional Electrical Stimulation in patients with a spinal cord injury

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001126303
Enrollment
15
Registered
2017-08-01
Start date
2021-03-01
Completion date
2022-03-01
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this physiology study is to determine the mechanisms through which Abdominal Functional Electrical Stimulation (Abdominal FES) improves respiratory function. This will be achieved by measuring a range of respiratory outcome measures with 15 tetraplegic participants, both with and without Abdominal FES, and before and after four weeks of Abdominal FES training.

Interventions

Intervention Electrical stimulation, the application of electrical pulses to a nerve, causes the associated muscle to contract, even when paralysed. For patients with a spinal cord injury, electrical stimulation of the abdominal muscles, termed Abdominal Functional Electrical Stimulation (Abdominal FES), has been shown to improve respiratory function. However, the mechanisms through which Abdominal FES improves respiratory function are poorly understood. In this study, 15 tetraplegic participan

Intervention Electrical stimulation, the application of electrical pulses to a nerve, causes the associated muscle to contract, even when paralysed. For patients with a spinal cord injury, electrical stimulation of the abdominal muscles, termed Abdominal Functional Electrical Stimulation (Abdominal FES), has been shown to improve respiratory function. However, the mechanisms through which Abdominal FES improves respiratory function are poorly understood. In this study, 15 tetraplegic participants will be asked to attend an initial assessment session at Neuroscience Research Australia. During this assessment session, Abdominal FES will be applied via four electrodes placed on the stomach. During this time ultrasound and Electromyography (EMG) will be used to measure diaphragm excursion and activity, and abdominal muscle thickness, with and without Abdominal FES. The activity of the inspiratory muscles with and without Abdominal FES will be measured using intraoesophageal EMG electrodes mounted on a gastro-oesophageal catheter. The two pressure transducers on this catheter will be used to measure gastric pressure and oesophageal pressure with and without Abdominal FES. The total duration of the assessment session will be approximately 90 minutes, with Abdominal FES applied for approximately 25% of this time. Participants will then be asked to apply Abdominal FES at home for one hour per day, five days per week, for four weeks. They will be trained in how to use this technology by a rehabilitation physiotherapist with over 10 years experience. A training diary will be used to measure compliance. Participants will then return to Neuroscience Research Australia, where the aforementioned assessment session will be repeated. Abdominal FES parameters will be personalised to each patient. Stimulation current will be adjusted until a strong visible contraction of the abdominal muscles is observed.

Sponsors

Neuroscience Research Australia
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Otherwise healthy participants who have had a cervical spinal cord injury (i.e. tetraplegia) for >1 year.

Exclusion criteria

Mechanical ventilator dependency Pregnancy Significant history of autonomic dysreflexia No visual response to Abdominal FES, suggesting that lower motor neurons are not intact Unstable chest or abdominal injury Bulbar dysfunction Recent respiratory complication Unable to give informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026