Spinal Stimulation in Chronic Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Official Title
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Non-invasive Spinal Cord Stimulation Combined With Activity-based Rehabilitation in Chronic Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: Transcutaneous spinal cord stimulation
* Other: Activity Based Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motor Complete Tetraplegia<br>C4-T1 American Spinal Injuries Association (ASIA) Impairment Scale Classification A or B spinal cord injury tscs with activity based therapy intervention | Device: Transcutaneous spinal cord stimulation<br>* Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes<br>Other: Activity Based Therapy<br>* Physical therapy<br>|
| Experimental: Motor Complete Paraplegia<br>T2-12 ASIA Impairment Scale A or B spinal cord injury tscs with activity based therapy intervention | Device: Transcutaneous spinal cord stimulation<br>* Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes<br>Other: Activity Based Therapy<br>* Physical therapy<br>|
| Experimental: Motor incomplete SCI<br>C4-T12 ASIA Impairment Scale C or D spinal cord injury tscs with activity based therapy intervention | Device: Transcutaneous spinal cord stimulation<br>* Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes<br>Other: Activity Based Therapy<br>* Physical therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Standards for the Neurological Classification of Spinal Cord Injury Classification scores (ISNCSCI ASIA chart) | Sensory and motor scores. Sensory scale 0-224, motor scale 0-100 with higher scores relating to increased sensation and motor power | 1 year | 
| Spinal Cord Independence Measure (SCIM) | Functional independence tool for spinal cord injury. Scale of 0-100, with higher scores meaning increased function | 1 year | 
| Berg Balance Score (where applicable) | Measure of standing balance. Scale of 0-56, with higher values meaning increased standing balance and reduced risk of falls | 1 year | 
| NeuroRecovery Scale (NRS) | Functional independence measure rated from 1a, the lowest classification of functioning to 4C, the highest classification of functioning | 1 year | 
| Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Test | Upper limb measure of sensation and function. Strength scored 0-100, sensation scored 0-24 and prehension scored 0-64. Increased score relates to increased hand strength, sensation and function | 1 year | 
| Capabilities of Upper Extremity Questionnaire (CUE) | Upper limb capability questionnaire with 32 items. Scores between 32-124 with higher scores associated with higher levels of function of the upper limb | 1 year | 
| Force dynamometry - hand | Grip and pinch strength using JTech force transducers. Measurements taken in Newtons | 1 year | 
| Electromyography (EMG) of muscle activity | Upper limb, trunk and lower limb EMG using the Delsys Trigno System | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organisation Quality Of Life - BREF (WHOQOL-BREF) | Quality of Life self report questionnaire with 26 items, subdivided into Physical Health (raw score range 7-35), Psychological Health (raw score range 6-30), Social Relationships (raw score range 3-15), Environment (raw score range 8-40) | 1 year | 
| International Spinal Cord Society Autonomic Standards Assessment Form | Bladder function questionnaire to document method of bladder management | 1 year | 
| International Spinal Cord Society Autonomic Standards Assessment Form | Bowel function questionnaire to document method of bowel management | 1 year | 
| International Spinal Cord Society Autonomic Standards Assessment Form | Cardiovascular function questionnaire to document ability to regulate cardiovascular system | 1 year | 
| International Spinal Cord Society Autonomic Standards Assessment Form | Sexual function questionnaire to document symptoms and impairments resulting from spinal cord injury | 1 year | 
| Modified Ashworth Scale | Spasticity measure, scores of 0 - no increase in spasticity to 4 - affected part rigid | 1 year | 
| Respiratory function tests of maximal inspiratory and expiratory pressures | Maximal inspiratory and expiratory pressures in breathing, | 1 year |