Clinical trial NCT04132596: Spinal Stimulation in Chronic Spinal Cord Injury
Official title: Non-invasive Spinal Cord Stimulation Combined With Activity-based Rehabilitation in Chronic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: The Neurokinex Charitable Trust
Sponsor class: OTHER
Collaborators: name: International Spinal Research Trust
First posted: 2019-10-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Cohort study
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: International Standards for the Neurological Classification of Spinal Cord Injury Classification scores (ISNCSCI ASIA chart)
timeFrame: 1 year
measure: Spinal Cord Independence Measure (SCIM)
timeFrame: 1 year
measure: Berg Balance Score (where applicable)
timeFrame: 1 year
measure: NeuroRecovery Scale (NRS)
timeFrame: 1 year
measure: Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Test
timeFrame: 1 year
measure: Capabilities of Upper Extremity Questionnaire (CUE)
timeFrame: 1 year
measure: Force dynamometry - hand
timeFrame: 1 year
measure: Electromyography (EMG) of muscle activity
timeFrame: 1 year
Secondary outcomes:
measure: World Health Organisation Quality Of Life - BREF (WHOQOL-BREF)
timeFrame: 1 year
measure: International Spinal Cord Society Autonomic Standards Assessment Form
timeFrame: 1 year
measure: International Spinal Cord Society Autonomic Standards Assessment Form
timeFrame: 1 year
measure: International Spinal Cord Society Autonomic Standards Assessment Form
timeFrame: 1 year
measure: International Spinal Cord Society Autonomic Standards Assessment Form
timeFrame: 1 year
measure: Modified Ashworth Scale
timeFrame: 1 year
measure: Respiratory function tests of maximal inspiratory and expiratory pressures
timeFrame: 1 year
Other outcomes:
Locations:
city: Gatwick
country: United Kingdom
facility: Neurokinex
city: Hemel Hempstead
country: United Kingdom
facility: Neurokinex
Study officials:
affiliation: Clinical Lead Physiotherapist
name: Jane Symonds, Physio
role: PRINCIPAL_INVESTIGATOR
References: