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The Effect of Abdominal Functional Electrical Stimulation on Blood Pressure Control in Spinal Cord Injury

Abdominal Functional Electrical Stimulation for Orthostatic Hypotension in Adults with Spinal Cord Injury

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000086864
Enrollment
18
Registered
2021-02-01
Start date
2021-03-01
Completion date
2021-12-01
Last updated
2021-02-08

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

Conditions

None listed

Brief summary

Spinal cord injury results in a devastating change in a person’s life quality due to a loss in function to not only voluntary motor control but also to regulatory systems that control bodily processes. Over 200,000 new cases of spinal cord injuries occur each year, with more than half of these injuries occur 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. A treatment that may increase blood pressure is electrical muscle stimulation. Stimulation is applied to the muscles through surface electrodes and transfer a current that activates muscles fibres and nerves. This study will investigate whether electrical stimulation of the abdominal muscles can improve blood pressure control for people with a spinal cord injury.

Interventions

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 (F

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.

Sponsors

Neuroscience Research Australia
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

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

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026