Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001126303
Ethics application status
Approved
Date submitted
28/07/2017
Date registered
1/08/2017
Date last updated
11/02/2021
Date data sharing statement initially provided
11/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the mechanisms of Abdominal Functional Electrical Stimulation in patients with a spinal cord injury
Scientific title
Understanding the mechanisms of Abdominal Functional Electrical Stimulation in patients with a spinal cord injury
Secondary ID [1] 292534 0
None
Universal Trial Number (UTN)
U1111-1199-8522
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 304190 0
Condition category
Condition code
Neurological 303519 303519 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298731 0
Rehabilitation
Intervention code [2] 298732 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302903 0
Change in Gastric pressure measured using intraoesophageal pressure transducers
Timepoint [1] 302903 0
With and without Abdominal FES, and before and after 4 weeks of Abdominal FES training
Secondary outcome [1] 337390 0
Change in Oesophageal pressure measured using intraoesophageal pressure transducers
Timepoint [1] 337390 0
With and without Abdominal FES, and before and after 4 weeks of Abdominal FES training
Secondary outcome [2] 337391 0
Change in Diaphragm excursion measured using ultrasound
Timepoint [2] 337391 0
With and without Abdominal FES, and before and after 4 weeks of Abdominal FES training
Secondary outcome [3] 337392 0
Change in Diaphragm activity measured using surface EMG
Timepoint [3] 337392 0
With and without Abdominal FES, and before and after 4 weeks of Abdominal FES training
Secondary outcome [4] 337393 0
Change in Abdominal muscle thickness measured using ultrasound
Timepoint [4] 337393 0
With and without Abdominal FES, and before and after 4 weeks of Abdominal FES training
Secondary outcome [5] 337399 0
Change in inspiratory muscle activity measured using intraoesophageal EMG
Timepoint [5] 337399 0
With and without Abdominal FES, and before and after 4 weeks of Abdominal FES training

Eligibility
Key inclusion criteria
Otherwise healthy participants who have had a cervical spinal cord injury (i.e. tetraplegia) for >1 year.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
Based on previous research by our group, a sample size of n=15 will enable us to identify a 21.4 cmH2O increase in gastric pressure with a power of 90% (SD=23.2) using with a two-tailed paired t-test (alpha=0.05).

Analysis
Gastric and oesophageal pressure, diaphragm excursion and activity, inspiratory muscle activity and abdominal muscle thickness, with and without Abdominal FES and before and after Abdominal FES training, will be combined for all 15 participants. Based on the outcome of a normality test, a paired t-test or Wilcoxon signed rank test will be used to test for a significant difference in all outcome measures with and without Abdominal FES and before and after Abdominal FES training.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
Date of last participant enrolment
Anticipated
1/03/2022
Actual
Date of last data collection
Anticipated
1/03/2022
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8624 0
Neuroscience Research Australia (NeuRA) - Randwick
Recruitment postcode(s) [1] 16732 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 297107 0
Government body
Name [1] 297107 0
National Health and Medical Research Council (NHMRC) Fellowship Funds
Country [1] 297107 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 296118 0
None
Name [1] 296118 0
Address [1] 296118 0
Country [1] 296118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298285 0
University of New South Wales HREC
Ethics committee address [1] 298285 0
Ethics committee country [1] 298285 0
Australia
Date submitted for ethics approval [1] 298285 0
09/06/2017
Approval date [1] 298285 0
19/07/2017
Ethics approval number [1] 298285 0
HC17516

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76582 0
Dr Euan McCaughey
Address 76582 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 76582 0
Australia
Phone 76582 0
+61 2 9399 1827
Fax 76582 0
Email 76582 0
[email protected]
Contact person for public queries
Name 76583 0
Euan McCaughey
Address 76583 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 76583 0
Australia
Phone 76583 0
+61 2 9399 1827
Fax 76583 0
Email 76583 0
[email protected]
Contact person for scientific queries
Name 76584 0
Euan McCaughey
Address 76584 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 76584 0
Australia
Phone 76584 0
+61 2 9399 1827
Fax 76584 0
Email 76584 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.