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Spinal Stimulation in Chronic Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04132596
Recruitment Status : Completed
First Posted : October 21, 2019
Last Update Posted : December 29, 2022
Sponsor:
Collaborator:
International Spinal Research Trust
Information provided by (Responsible Party):
The Neurokinex Charitable Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Transcutaneous spinal cord stimulation Other: Activity Based Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-invasive Spinal Cord Stimulation Combined With Activity-based Rehabilitation in Chronic Spinal Cord Injury
Actual Study Start Date : November 11, 2019
Actual Primary Completion Date : October 3, 2022
Actual Study Completion Date : October 3, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. International Standards for the Neurological Classification of Spinal Cord Injury Classification scores (ISNCSCI ASIA chart) [ Time Frame: 1 year ]
    Sensory and motor scores. Sensory scale 0-224, motor scale 0-100 with higher scores relating to increased sensation and motor power

  2. Spinal Cord Independence Measure (SCIM) [ Time Frame: 1 year ]
    Functional independence tool for spinal cord injury. Scale of 0-100, with higher scores meaning increased function

  3. Berg Balance Score (where applicable) [ Time Frame: 1 year ]
    Measure of standing balance. Scale of 0-56, with higher values meaning increased standing balance and reduced risk of falls

  4. NeuroRecovery Scale (NRS) [ Time Frame: 1 year ]
    Functional independence measure rated from 1a, the lowest classification of functioning to 4C, the highest classification of functioning

  5. Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Test [ Time Frame: 1 year ]
    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

  6. Capabilities of Upper Extremity Questionnaire (CUE) [ Time Frame: 1 year ]
    Upper limb capability questionnaire with 32 items. Scores between 32-124 with higher scores associated with higher levels of function of the upper limb

  7. Force dynamometry - hand [ Time Frame: 1 year ]
    Grip and pinch strength using JTech force transducers. Measurements taken in Newtons

  8. Electromyography (EMG) of muscle activity [ Time Frame: 1 year ]
    Upper limb, trunk and lower limb EMG using the Delsys Trigno System


Secondary Outcome Measures :
  1. World Health Organisation Quality Of Life - BREF (WHOQOL-BREF) [ Time Frame: 1 year ]
    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)

  2. International Spinal Cord Society Autonomic Standards Assessment Form [ Time Frame: 1 year ]
    Bladder function questionnaire to document method of bladder management

  3. International Spinal Cord Society Autonomic Standards Assessment Form [ Time Frame: 1 year ]
    Bowel function questionnaire to document method of bowel management

  4. International Spinal Cord Society Autonomic Standards Assessment Form [ Time Frame: 1 year ]
    Cardiovascular function questionnaire to document ability to regulate cardiovascular system

  5. International Spinal Cord Society Autonomic Standards Assessment Form [ Time Frame: 1 year ]
    Sexual function questionnaire to document symptoms and impairments resulting from spinal cord injury

  6. Modified Ashworth Scale [ Time Frame: 1 year ]
    Spasticity measure, scores of 0 - no increase in spasticity to 4 - affected part rigid

  7. Respiratory function tests of maximal inspiratory and expiratory pressures [ Time Frame: 1 year ]
    Maximal inspiratory and expiratory pressures in breathing,


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132596


Locations
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United Kingdom
Neurokinex
Gatwick, United Kingdom, RH10 9NE
Neurokinex
Hemel Hempstead, United Kingdom, HP2 7BW
Sponsors and Collaborators
The Neurokinex Charitable Trust
International Spinal Research Trust
Investigators
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Principal Investigator: Jane Symonds, Physio Clinical Lead Physiotherapist
More Information
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Additional Information:

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Responsible Party: The Neurokinex Charitable Trust
ClinicalTrials.gov Identifier: NCT04132596    
Other Study ID Numbers: Pathfinder 2.0
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: December 29, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System