An interventional study of Transcutaneous spinal cord stimulation and Activity Based Therapy in Spinal Cord Injuries, sponsored by The Neurokinex Charitable Trust. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-29.
Sponsored by The Neurokinex Charitable Trust · Not applicable, Interventional, and Treatment
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 12 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →This is the only study on the registry with The Neurokinex Charitable Trust as lead sponsor.
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Exclusion Criteria:
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 · Other: Activity Based Therapy
T2-12 ASIA Impairment Scale A or B spinal cord injury tscs with activity based therapy intervention
Device: Transcutaneous spinal cord stimulation · Other: Activity Based Therapy
C4-T12 ASIA Impairment Scale C or D spinal cord injury tscs with activity based therapy intervention
Device: Transcutaneous spinal cord stimulation · Other: Activity Based Therapy
Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes
Physical therapy
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
Time frame: 1 year
Spinal Cord Independence Measure (SCIM)
Functional independence tool for spinal cord injury. Scale of 0-100, with higher scores meaning increased function
Time frame: 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
Time frame: 1 year
NeuroRecovery Scale (NRS)
Functional independence measure rated from 1a, the lowest classification of functioning to 4C, the highest classification of functioning
Time frame: 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
Time frame: 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
Time frame: 1 year
Force dynamometry - hand
Grip and pinch strength using JTech force transducers. Measurements taken in Newtons
Time frame: 1 year
Electromyography (EMG) of muscle activity
Upper limb, trunk and lower limb EMG using the Delsys Trigno System
Time frame: 1 year
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)
Time frame: 1 year
International Spinal Cord Society Autonomic Standards Assessment Form
Bladder function questionnaire to document method of bladder management
Time frame: 1 year
International Spinal Cord Society Autonomic Standards Assessment Form
Bowel function questionnaire to document method of bowel management
Time frame: 1 year
International Spinal Cord Society Autonomic Standards Assessment Form
Cardiovascular function questionnaire to document ability to regulate cardiovascular system
Time frame: 1 year
International Spinal Cord Society Autonomic Standards Assessment Form
Sexual function questionnaire to document symptoms and impairments resulting from spinal cord injury
Time frame: 1 year
Modified Ashworth Scale
Spasticity measure, scores of 0 - no increase in spasticity to 4 - affected part rigid
Time frame: 1 year
Respiratory function tests of maximal inspiratory and expiratory pressures
Maximal inspiratory and expiratory pressures in breathing,
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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