To investigate transcutaneous spinal cord stimulation combined with locomotor training on walking ability in people with chronic spinal cord injury: a multi-centre double-blinded randomised sham-controlled trial

euroscience Research Australia0 sites50 target enrollmentNovember 20, 2020

Overview

No summary available.

Registry

who.int

Start Date

November 20, 2020

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

euroscience Research Australia

•A person will be eligible to participate if they:
•have a SCI sustained a minimum of 12 months prior to consent
•have bilateral motor levels between T1 and T11
•have a Walking Index for Spinal Cord Injury II (WISCI II) between Level 1 and 6\*
•have a reproducible, voluntary muscle flicker/contraction in at least one muscle that flexes or extends the hip, knee, ankle or big toe, on either side of the body
•are willing and able to participate in the stimulation/locomotor training program 3 times a week for 12 weeks, including one follow\-up visit at 16 weeks
•are aged 16 years or over at the time of consent and able to give informed consent
•are considered by their spinal specialist to be medically stable to undertake the program (including clearance for standing/locomotor training)
•\*1 \= Ambulates in parallel bars, with braces and physical assistance of two persons, but less than 10 metres
•6 \= Ambulates with walker, with braces and physical assistance of one person, 10 metres

•A person will be ineligible to participate if they:
•have a history of clinically significant autonomic dysreflexia in response to electrical stimulation
•cannot tolerate transcutaneous spinal stimulation at a therapeutic intensity
•have a history of hypotension in response to prolonged standing
•have a progressive neurological disease and any other major neurological lesion additional to the spinal cord injury, e.g., a severe traumatic brain injury or stroke
•have a history of long\-bone fracture, family history of fragility fracture or any disorders of the bone, such as Paget’s disease
•have a syringomyelia (syrinx) on recent MRI. Radiological findings such as myelomalacia which have been evaluated by a neurosurgeon as non\-progressive may still be eligible
•have had open surgery within the last 3 months
•unable to elicit reflexes whilst experiencing the stimulation suggesting a lower motor neurone lesion
•have severe lower limb spasticity (MAS \= 4 in any lower limb muscle)