Spinal Stimulation for Chronic Complete Tetraplegia (Complete TESCS)

NHS Trust

Status

Not yet enrolling

Conditions

Spinal Cord Injuries

Treatments

Other: Therapy with and without spinal cord stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05522920

GN20NE064

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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