ACTRN12623000793617
Recruiting
未知
Get A Grip: Spinal stimulation for upper limb and respiratory function in incomplete tetraplegia: a Bayesian Optimal Phase II trial
euroscience Research Australia (NeuRA)0 sites48 target enrollmentJuly 24, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Spinal Cord Injury- Incomplete tetraplegia
- Sponsor
- euroscience Research Australia (NeuRA)
- Enrollment
- 48
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18 years or older
- •\- Have a motor incomplete (American Spinal Injury Association (ASIA) Impairment Scale (AIS) C or D) spinal cord injury sustained a minimum of 12 months prior to consent.
- •\- Able to breathe independently
- •\- Have an injury level between C2 and C8 neurological levels.
- •\- Willing and able to participate in a training program three times a week for 6 weeks
Exclusion Criteria
- •Have a history of clinically significant autonomic dysreflexia in response to electrical stimulation
- •Unable to elicit reflexes whilst experiencing the stimulation
- •Cannot tolerate spinal stimulation at a therapeutic intensity
- •Have a progressive neurological disease or other major neurological condition other than the spinal cord injury (e.g., severe traumatic brain injury or stroke)
- •Open surgery within the last 3 months
- •Syrinx (fluid\-filled cyst or cavity in spinal cord) on recent MRI
- •Severe upper limb spasticity or contractures
- •Any serious medical condition, cognitive impairment (i.e. trouble remembering or learning), drug dependency, psychiatric illness or behavioural problem preventing you from adhering to the protocol
- •Cardiac pacemaker or pregnant
- •Stem cell or olfactory ensheathing cell therapy within the last 5 years
Outcomes
Primary Outcomes
Not specified
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