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Spinal Stimulation in Chronic Spinal Cord Injury

NCT ID: NCT04132596

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-11

Study Completion Date

2022-10-03

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Cohort study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Transcutaneous spinal cord stimulation

Intervention Type DEVICE

Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes

Activity Based Therapy

Intervention Type OTHER

Physical therapy

Motor Complete Paraplegia

T2-12 ASIA Impairment Scale A or B spinal cord injury tscs with activity based therapy intervention

Group Type EXPERIMENTAL

Transcutaneous spinal cord stimulation

Intervention Type DEVICE

Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes

Activity Based Therapy

Intervention Type OTHER

Physical therapy

Motor incomplete SCI

C4-T12 ASIA Impairment Scale C or D spinal cord injury tscs with activity based therapy intervention

Group Type EXPERIMENTAL

Transcutaneous spinal cord stimulation

Intervention Type DEVICE

Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes

Activity Based Therapy

Intervention Type OTHER

Physical therapy

Interventions

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Transcutaneous spinal cord stimulation

Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes

Intervention Type DEVICE

Activity Based Therapy

Physical therapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Spinal Research Trust

OTHER

Sponsor Role collaborator

The Neurokinex Charitable Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane Symonds, Physio

Role: PRINCIPAL_INVESTIGATOR

Clinical Lead Physiotherapist

Locations

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Neurokinex

Gatwick, , United Kingdom

Site Status

Neurokinex

Hemel Hempstead, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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 Feb 24:S1094-7159(25)00007-8. doi: 10.1016/j.neurom.2025.01.005. Online ahead of print.

Reference Type DERIVED
PMID: 39998450 (View on PubMed)

Related Links

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http://www.neurokinex.org

Related Info

Other Identifiers

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Pathfinder 2.0

Identifier Type: -

Identifier Source: org_study_id