Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000086864
Ethics application status
Approved
Date submitted
11/12/2020
Date registered
1/02/2021
Date last updated
1/02/2021
Date data sharing statement initially provided
1/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Abdominal Functional Electrical Stimulation on Blood Pressure Control in Spinal Cord Injury
Scientific title
Abdominal Functional Electrical Stimulation for Orthostatic Hypotension in Adults with Spinal Cord Injury
Secondary ID [1] 303006 0
None
Universal Trial Number (UTN)
U1111-1262-6296
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 320063 0
tetraplegia 320064 0
paralysis 320065 0
Condition category
Condition code
Neurological 317992 317992 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 317993 317993 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 317994 317994 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are over 200,000 new cases of spinal cord injury globally each year, with more than 70% of these injuries occurring at the level of the cervical spine and upper thoracic spine (C1-T5). Injuries to these levels result in alteration to the sympathetic nervous system which causes dysregulation to blood pressure control, can lead to swings in blood pressure, and most commonly hypotension especially when seated upright or standing. We have shown that surface Functional Electrical Stimulation (FES) of the abdominal muscles, termed Abdominal FES, can improve respiratory function and may assist weaning from mechanical ventilation in spinal cord injury. During these studies we also observed an increase in systolic blood pressure.

Eighteen participants will be recruited to this single centre randomised, placebo controlled, trial. Participants with a spinal cord injury in the region C1-T5 will be recruited between 6 weeks and 6 months post injury. Nine participants will be randomly allocated to receive Abdominal FES and 9 will receive a placebo. In the Abdominal FES group, Abdominal FES will be applied for 45 minutes per day, 5 days per week, for 2 weeks.

Specifically, Abdominal FES will be delivered, via electrodes placed over the posterolateral surface of the abdomen. The stimulation amplitude will be set to cause a strong visible muscle contraction (usually 30-60 mA) at a frequency of 50Hz and 350 microseconds pulsewidth. Stimulation amplitude will be evaluated every 5 minutes to ensure that stimulation is still tolerable and causing a suitable muscle contraction. Stimulation will be applied by a local physiotherapist. A daily training diary will be kept to monitor compliance.
Intervention code [1] 319294 0
Treatment: Devices
Comparator / control treatment
Participants in the placebo group will receive sham Abdominal FES for 45 minutes per day, five days per week, for 2 weeks. Placebo Abdominal FES will be similar to active FES in all respects except for the stimulation intensity, which will be kept to a level which does not cause a muscle contraction.

Specifically, stimulation pulses will be delivered at a low current amplitude (< 10 mA) that does not cause abdominal muscle contraction. These settings were chosen so that participants experience the sensation of Abdominal FES without an abdominal muscle contraction. The placebo will be applied by a local physiotherapist. A daily training diary will be kept to monitor compliance.
Control group
Placebo

Outcomes
Primary outcome [1] 325996 0
Immediate change in systolic blood pressure with abdominal electrical stimulation during a Head-up tilt (HUT) orthostatic tilt measured using a Finopress blood pressure measurement system
Timepoint [1] 325996 0
Before and after 2 weeks of Abdominal FES training
Primary outcome [2] 326201 0
Immediate change in systolic blood pressure without abdominal electrical stimulation during a Head-up tilt (HUT) orthostatic tilt measured using a Finopress blood pressure measurement system
Timepoint [2] 326201 0
Before and after 2 weeks of Abdominal FES training
Secondary outcome [1] 389802 0
Immediate change in diastolic blood pressure with abdominal electrical stimulation during a Head-up tilt (HUT) orthostatic tilt measured using a Finopress blood pressure measurement system
Timepoint [1] 389802 0
Before and after 2 weeks of Abdominal FES training
Secondary outcome [2] 389803 0
Forced Exhaled Volume in one Second (FEV1) measured using a spirometer
Timepoint [2] 389803 0
Before and after 2 weeks of Abdominal FES training
Secondary outcome [3] 389804 0
Forced Vital Capacity (FVC) measured using a spirometer
Timepoint [3] 389804 0
Before and after 2 weeks of Abdominal FES training
Secondary outcome [4] 389805 0
Peak Expiratory Flow (PEF)measured using a spirometer
Timepoint [4] 389805 0
Before and after 2 weeks of Abdominal FES training
Secondary outcome [5] 389806 0
Maximum Inspiratory Pressure (MIP) measured using a mouth pressure meter
Timepoint [5] 389806 0
Before and after 2 weeks of Abdominal FES training
Secondary outcome [6] 389807 0
Maximum Expiratory Pressure (MEP) measured using a mouth pressure meter
Timepoint [6] 389807 0
Before and after 2 weeks of Abdominal FES training
Secondary outcome [7] 390492 0
Immediate change in diastolic blood pressure without abdominal electrical stimulation during a Head-up tilt (HUT) orthostatic tilt
Timepoint [7] 390492 0
Before and after 2 weeks of Abdominal FES training measured using a Finopress blood pressure measurement system

Eligibility
Key inclusion criteria
• Greater than 6 weeks post-injury.
• Spinal injury to C1- T5 with an American Spinal Injuries Association Impairment Scale of A-C
• Tilt table naive
• Abdominal FES naive
• Seated systolic blood pressure of < 100 mmHg.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Greater than 26 weeks post injury
• Mechanical ventilation dependency
• American Spinal Injuries Association Impairment Scale D or E (Patients have near normal function and have low risk of hypotension).
• Progressive neurological disease or chronic respiratory disease.
• Physical obstacles that stop the ability to perform Abdominal FES (e.g. pregnancy, abdominal trauma, pacemaker)
• No response to FES
• Current use of blood pressure medication Feeding tube
• Colostomy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participant will be randomly assigned to active or placebo Abdominal FES in a 1:1 ratio using a random, secure, web-based program (REDCap) by an independent investigator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE CALCULATION
The study by Aslan et al. was used to calculate the sample size required to detect a change in systolic blood pressure during a HUT orthostatic challenge. Based on the reference group mean being 70 mmHg and the treatment group being 119 and the SD of the population being 27, a power of 0.9, and a Wilcoxon signed rank test, the sample size required is 14 participants (7 per group). Allowing for 10% technical failure and 10% dropout, 18 participants (9 per group) will be recruited.

STATISTICAL ANALYSIS PLAN
Participant variables will be presented using means and standard deviations for continuous normally distributed variables, medians and interquartile ranges for continuous non-normally distributed variables, and proportions and absolute numbers for categorical variables.
The primary outcome in this study is systolic blood pressure during an orthostatic tilt maneuver during the application of Abdominal FES. The primary outcome will be analysed using a Wilcoxon-Mann-Whitney test to compare systolic blood pressure between the active and sham groups. A similar method will be used to compare diastolic blood pressure between groups. General linear models will be used to compare seated blood pressure and stimulated and unstimulated blood pressure between groups, before and after the two week intervention period. Generalised linear models will be used to compare respiratory function (as % predicted) between the intervention and sham groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
Date of last participant enrolment
Anticipated
1/12/2021
Actual
Date of last data collection
Anticipated
22/12/2021
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18188 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 32245 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 307414 0
Government body
Name [1] 307414 0
National Health and Medical Research Council
Country [1] 307414 0
Australia
Funding source category [2] 307415 0
Government body
Name [2] 307415 0
NSW Health
Country [2] 307415 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 308084 0
None
Name [1] 308084 0
Address [1] 308084 0
Country [1] 308084 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307500 0
South Eastern Sydney LHD HREC
Ethics committee address [1] 307500 0
Ethics committee country [1] 307500 0
Australia
Date submitted for ethics approval [1] 307500 0
Approval date [1] 307500 0
17/12/2019
Ethics approval number [1] 307500 0
2019/ETH13271

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

Contacts
Principal investigator
Name 107454 0
Dr Euan McCaughey
Address 107454 0
Neuroscience Research Australia
139 Barker St
Randwick, NSW 2031
Country 107454 0
Australia
Phone 107454 0
+61 0293991064
Fax 107454 0
Email 107454 0
[email protected]
Contact person for public queries
Name 107455 0
Euan McCaughey
Address 107455 0
Neuroscience Research Australia
139 Barker St
Randwick, NSW 2031
Country 107455 0
Australia
Phone 107455 0
+61 0293991064
Fax 107455 0
Email 107455 0
[email protected]
Contact person for scientific queries
Name 107456 0
Euan McCaughey
Address 107456 0
Neuroscience Research Australia
139 Barker St
Randwick, NSW 2031
Country 107456 0
Australia
Phone 107456 0
+61 0293991064
Fax 107456 0
Email 107456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Upon publication, with no end limit
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
Through supplementary information in open access publication


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.