Spinal Stimulation in Chronic Spinal Cord Injury

The Neurokinex Charitable Trust

Status

Completed

Conditions

Spinal Cord Injuries

Treatments

Device: Transcutaneous spinal cord stimulation

Other: Activity Based Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04132596

Pathfinder 2.0

Details and patient eligibility

About

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 studies have included invasive implanted devices and non-invasive transcutaneous systems using different combinations of stimulation current, waveform, amplitude, duration and spinal levels targeted. Invasive and non-invasive systems have been demonstrated to permit individuals with chronic spinal cord injury (SCI), previously considered to have complete injuries on the International Standards for the Neurological Classification of Spinal Cord Injuries (ISNCSCI) scale (Classification A), to regain some degree of voluntary and autonomic function during periods of stimulation. The aim of this study is to evaluate the effects of a novel non-invasive transcutaneous electrical spinal cord stimulation system (tSCS) combined with activity-based rehabilitation in patients who have paralysis of their legs and/or arms. We will examine participants for any changes in sensory, motor or autonomic function. We will use a transcutaneous spinal cord stimulator that has been designed to deliver safe and tolerable bursts of high frequency pulsed current that minimise the capacitance efforts of the skin surface and maximise conductance of a second waveform using low frequency current to target neural structures. We aim to investigate this form of neuromodulation with a small group of individuals with chronic spinal cord injury. Our goal is to observe and describe any short term or lasting changes in function that can safely and comfortably be derived from this combination of spinal stimulation and activity-based rehabilitation. If this therapy can cause lasting improvements in sensory, motor, respiratory or autonomic function, then this may lead to a greater degree of functional independence for these individuals.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 3 patient groups

Motor Complete Tetraplegia

Experimental group

Description:

C4-T1 American Spinal Injuries Association (ASIA) Impairment Scale Classification A or B spinal cord injury tscs with activity based therapy intervention

Treatment:

Device: Transcutaneous spinal cord stimulation

Other: Activity Based Therapy

Motor Complete Paraplegia

Experimental group

Description:

T2-12 ASIA Impairment Scale A or B spinal cord injury tscs with activity based therapy intervention

Treatment:

Device: Transcutaneous spinal cord stimulation

Other: Activity Based Therapy

Motor incomplete SCI

Experimental group