Spinal Stimulation in Chronic Spinal Cord Injury

NCT04132596 | Completed DMC FDA Device

• 1 other identifier: Pathfinder 2.0
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (7)

• World Health Organisation Quality Of Life - BREF (WHOQOL-BREF)

  1 year

• International Spinal Cord Society Autonomic Standards Assessment Form

  1 year

• International Spinal Cord Society Autonomic Standards Assessment Form

  1 year

• International Spinal Cord Society Autonomic Standards Assessment Form

  1 year

• International Spinal Cord Society Autonomic Standards Assessment Form

  1 year

Study Arms (3)

Motor Complete Tetraplegia

EXPERIMENTAL

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

Motor Complete Paraplegia

EXPERIMENTAL

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

Motor incomplete SCI

EXPERIMENTAL

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

Interventions

Transcutaneous spinal cord stimulation DEVICE

Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes

Motor Complete Paraplegia; Motor Complete Tetraplegia; Motor incomplete SCI

Activity Based Therapy OTHER

Physical therapy

Motor Complete Paraplegia; Motor Complete Tetraplegia; Motor incomplete SCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Neurokinex Charitable Trust: lead
• International Spinal Research Trust: collaborator

Study Sites (2)

Neurokinex

Gatwick, RH10 9NE, United Kingdom

Location

Neurokinex

Hemel Hempstead, HP2 7BW, United Kingdom

Location

Related Publications (1)

• Suggitt J, Symonds J, D'Amico JM. Safety and Effectiveness of Multisite Transcutaneous Spinal Cord Stimulation Combined With Activity-Based Therapy When Delivered in a Community Rehabilitation Setting: A Real-World Pilot Study. Neuromodulation. 2025 Oct;28(7):1144-1156. doi: 10.1016/j.neurom.2025.01.005. Epub 2025 Feb 24.

  PMID: 39998450 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jane Symonds, Physio

  Clinical Lead Physiotherapist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort study

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: November 11, 2019
• Primary Completion: October 3, 2022
• Study Completion: October 3, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)