Non-invasive Spinal Cord Stimulation Combined With Activity-based Therapy in Chronic Complete High Level Spinal Cord Injury

NHS Greater Glasgow and Clyde0 sites12 target enrollmentAugust 2022

ConditionsSpinal Cord Injuries

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Cord Injuries
Sponsor: NHS Greater Glasgow and Clyde
Enrollment: 12
Primary Endpoint: Acceptance
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is investigate the acceptability and effectiveness of transcutaneous spinal cord stimulation in people with complete high level spinal cord injury.

Registry

clinicaltrials.gov

Start Date

August 2022

End Date

December 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

NHS Greater Glasgow and Clyde

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and able to give informed consent for participation in the study
•Aged ≥18 years
•Injury level C3-C7, American Spinal Cord injury Association Impairment Scale (ASIA) A
•≥1 year post-injury
•Medically stable, cognitively intact, and able to breathe independently
•Able to attend all sessions two or three times per week, for 2 h sessions and assessments

Exclusion Criteria

•Any implanted active metallic device including, but not limited to neurostimulators, cochlear implants, pacemakers, implantable defibrillators, or drug delivery pumps
•Possible, suspected, or confirmed pregnancy and/or lactation
•Recent history or fracture, contractures or pressure sore, deep vein thrombosis (DVT) or urinary tract, or other infection that may interfere with the intervention and training
•History of epilepsy and/or seizures
•Severe spasticity which has been unstable over the 3 months prior to enrolment and is not expected to change and/or taking varying doses of anti-spasticity medications which could not be tapered to a stable dose and are not expected to change
•Botulinum toxin injections within 6 months of participation
•Non-injury related neurological impairment
•Clinically significant severe depression in spite of treatment
•Cardiovascular disease
•Autonomic dysreflexia that is severe, ongoing, and has required medical treatment within the past month

Outcomes

Primary Outcomes

Acceptance

Time Frame: 26 weeks at the end of intervention

Whether the treatment protocol is acceptable by people with complete tetraplegia. This will be assessed using semi structured interview results of which will be analysed qualitatively to determine the number of participants who would use the therapy on an ongoing basis.

Secondary Outcomes

Neurophysiological change(26 and 38 weeks, at the end of intervention and at follow up respectively)
Autonomic function(26 weeks at the end of intervention)
Change in perceived health status(26 weeks at the end of intervention)
Sensation(26 weeks at the end of intervention)
Spasticity(26 weeks at the end of intervention)
Clinical effectiveness of spinal cord stimulation using GRASSP tool(26 and 38 weeks, at the end of intervention and at follow up respectively)