Spinal Stimulation in Chronic Spinal Cord Injury

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Transcutaneous spinal cord stimulation; Other: Activity Based Therapy

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Gatwick, United Kingdom, RH10 9NE
    • Neurokinex
  • Hemel Hempstead, United Kingdom, HP2 7BW
    • Neurokinex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motor Complete Tetraplegia; 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; Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes; Other: Activity Based Therapy; Physical therapy
Experimental: Motor Complete Paraplegia; T2-12 ASIA Impairment Scale A or B spinal cord injury tscs with activity based therapy intervention	Device: Transcutaneous spinal cord stimulation; Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes; Other: Activity Based Therapy; Physical therapy
Experimental: Motor incomplete SCI; C4-T12 ASIA Impairment Scale C or D spinal cord injury tscs with activity based therapy intervention	Device: Transcutaneous spinal cord stimulation; Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes; Other: Activity Based Therapy; Physical therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Neurokinex Charitable Trust
• Collaborators: International Spinal Research Trust
• Investigators: Principal Investigator: Jane Symonds, Physio, Clinical Lead Physiotherapist

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): October 3, 2022
• Study Completion (Actual): October 3, 2022

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: Pathfinder 2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes