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Spinal Cord InjuriesNCT04132596

Spinal Stimulation in Chronic Spinal Cord Injury

A study testing Transcutaneous spinal cord stimulation and Activity Based Therapy in people with Spinal Cord Injuries, run by The Neurokinex Charitable Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Electrical spinal stimulation combined with activity-based rehabilitation (ABR) can improve motor and autonomic function in individuals suffering from varying degrees of paralysis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Transcutaneous spinal cord stimulation and Activity Based Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited Kingdom
Study dates
11 Nov 2019to 3 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 17Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Neurokinex

    Gatwick, RH10 9NE

  • Neurokinex

    Hemel Hempstead, HP2 7BW

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
Transcutaneous spinal cord stimulation, Activity Based Therapy
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous spinal cord stimulationDevice

    Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes

  • Activity Based TherapyOther

    Physical therapy

Study groups in NCT04132596
Study groupRoleWhat they receive
Motor Complete TetraplegiaExperimentalC4-T1 American Spinal Injuries Association (ASIA) Impairment Scale Classification A or B spinal cord injury tscs with activity based therapy intervention
Receives: Device: Transcutaneous spinal cord stimulation; Other: Activity Based Therapy
Motor Complete ParaplegiaExperimentalT2-12 ASIA Impairment Scale A or B spinal cord injury tscs with activity based therapy intervention
Receives: Device: Transcutaneous spinal cord stimulation; Other: Activity Based Therapy
Motor incomplete SCIExperimentalC4-T12 ASIA Impairment Scale C or D spinal cord injury tscs with activity based therapy intervention
Receives: Device: Transcutaneous spinal cord stimulation; Other: Activity Based Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 year

  2. Spinal Cord Independence Measure (SCIM)

    Functional independence tool for spinal cord injury. Scale of 0-100, with higher scores meaning increased function

    Measured: 1 year

  3. 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

    Measured: 1 year

  4. NeuroRecovery Scale (NRS)

    Functional independence measure rated from 1a, the lowest classification of functioning to 4C, the highest classification of functioning

    Measured: 1 year

  5. 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

    Measured: 1 year

  6. 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

    Measured: 1 year

  7. Force dynamometry - hand

    Grip and pinch strength using JTech force transducers. Measurements taken in Newtons

    Measured: 1 year

  8. Electromyography (EMG) of muscle activity

    Upper limb, trunk and lower limb EMG using the Delsys Trigno System

    Measured: 1 year

Secondary outcomes (7)

  1. 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)

    Measured: 1 year

  2. International Spinal Cord Society Autonomic Standards Assessment Form

    Bladder function questionnaire to document method of bladder management

    Measured: 1 year

  3. International Spinal Cord Society Autonomic Standards Assessment Form

    Bowel function questionnaire to document method of bowel management

    Measured: 1 year

  4. International Spinal Cord Society Autonomic Standards Assessment Form

    Cardiovascular function questionnaire to document ability to regulate cardiovascular system

    Measured: 1 year

  5. International Spinal Cord Society Autonomic Standards Assessment Form

    Sexual function questionnaire to document symptoms and impairments resulting from spinal cord injury

    Measured: 1 year

  6. Modified Ashworth Scale

    Spasticity measure, scores of 0 - no increase in spasticity to 4 - affected part rigid

    Measured: 1 year

  7. Respiratory function tests of maximal inspiratory and expiratory pressures

    Maximal inspiratory and expiratory pressures in breathing,

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start11 Nov 2019
  3. Primary completion3 Oct 2022
  4. Study completion3 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Cohort study
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04132596
Sponsor's protocol ID
Pathfinder 2.0
Status last verified
Dec 2022
First submitted
17 Oct 2019
Last updated
29 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 39998450

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous spinal cord stimulation and Activity Based Therapy in people with Spinal Cord Injuries, run by The Neurokinex Charitable Trust at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Standards for the Neurological Classification of Spinal Cord Injury Classification scores (ISNCSCI ASIA chart) (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04132596, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.

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