Status:
COMPLETED
Spinal Stimulation in Chronic Spinal Cord Injury
Lead Sponsor:
The Neurokinex Charitable Trust
Collaborating Sponsors:
International Spinal Research Trust
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Electrical spinal stimulation combined with activity-based rehabilitation (ABR) can improve motor and autonomic function in individuals suffering from varying degrees of paralysis. Spinal stimulation ...
Eligibility Criteria
Inclusion
- Participant is willing and able to give informed consent for participation in the study
- Aged 18 years or over
- Injury level C4-T12
- At least one year post spinal cord injury
- Medically stable and cognitively intact
- Independent respiration, not requiring any ventilatory support
Exclusion
- Any active implanted metallic device including, but not limited to neurostimulators, cochlear implants, pacemakers, implantable defibrillators or drug delivery pump
- Implanted surgical hardware that is not compatible with MRI scanners
- Possible, suspected or confirmed pregnancy and/or lactation
- Active Heterotopic Ossification
- Recent history or fracture, contractures or pressure sore, deep vein thrombosis or urinary tract or other infection that may interfere with the intervention and training.
- History of epilepsy and/or seizures.
- Severe spasticity which have been unstable over the past 3 months prior to enrolment and not expected to change; taking varying doses of anti-spasticity medications which could not be tapered to a stable dose and is not expected to change
- Botulinum toxin injections within 6 months of participation (excluding bladder)
- Non-injury related neurological impairment
- Clinically significant severe depression in spite of treatment
- Patients who have cardiovascular disease
- Patients with Autonomic Dysreflexia that is severe, ongoing and has required medical treatment within the past one month
- Active aggressive tumour within or surrounding the spinal cord or brain stem
- A syrinx (fluid filled cavity) in the spinal cord
- Skin conditions or allergies that may affect electrode placement
- Bodyweight over 120kg (due to inability to use some of the study equipment)
- Patients who do not understand English
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04132596
Start Date
November 11 2019
End Date
October 3 2022
Last Update
December 29 2022
Active Locations (2)
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1
Neurokinex
Gatwick, United Kingdom, RH10 9NE
2
Neurokinex
Hemel Hempstead, United Kingdom, HP2 7BW