Clinical trial NCT05522920: Spinal Stimulation for Chronic Complete Tetraplegia
Official title: Non-invasive Spinal Cord Stimulation Combined With Activity-based Therapy in Chronic Complete High Level Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: International Spinal Research Trust
First posted: 2022-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive study intervention
Primary purpose: TREATMENT

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.


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
* Skin conditions or allergies that may affect electrode placement
* Do not understand English
* Received a stem cell treatment or other treatment that could possibly promote or attenuate neuroplastic changes in spinal or cortical function, within ≥2 years of enrolment; beyond this period, they may be included, provided the treatment was conducted in an accredited facility with proper ethics and regulatory approval.
* Involved in any other study involving stimulation of the spinal cord within 6 months of enrolment
* Information regarding recent rehabilitation or exercise programmes that participants may currently be engaged in will be discussed with clinical staff and fully documented for each participant

Primary outcomes:
measure: Acceptance
timeFrame: 26 weeks at the end of intervention
Secondary outcomes:
measure: Clinical effectiveness of spinal cord stimulation using GRASSP tool
timeFrame: 26 and 38 weeks, at the end of intervention and at follow up respectively
measure: Neurophysiological change
timeFrame: 26 and 38 weeks, at the end of intervention and at follow up respectively
measure: Sensation
timeFrame: 26 weeks at the end of intervention
measure: Spasticity
timeFrame: 26 weeks at the end of intervention
measure: Autonomic function
timeFrame: 26 weeks at the end of intervention
measure: Change in perceived health status
timeFrame: 26 weeks at the end of intervention
Other outcomes:
Locations:
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Mariel Purcell, Consultant
role: STUDY_DIRECTOR
References: