NCT04132596

Spinal Stimulation in Chronic Spinal Cord Injury

Completed NA Last updated 29 December 2022

What this trial tests

NA trial testing Transcutaneous spinal cord stimulation in Spinal Cord Injuries in 12 participants. Completed in 3 October 2022.

Timeline

11 November 2019

Primary endpoint
3 October 2022

3 October 2022

Quick facts

Lead sponsor	The Neurokinex Charitable Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	11 November 2019
Primary completion	3 October 2022
Estimated completion	3 October 2022
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Transcutaneous spinal cord stimulation
• Activity Based Therapy

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

The Neurokinex Charitable Trust

Who can join

18 and older, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Suggitt J, Symonds J, D'Amico JM. · · 2025 · cited 5× · PMID 39998450 · DOI 10.1016/j.neurom.2025.01.005
2. Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
   Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710
3. Extracellular Vesicles as Emerging Therapeutic Strategies in Spinal Cord Injury: Ready to Go.
   Jiang J, Wang Z, Bao Q, Chen S, et al · · 2025 · cited 2× · PMID 40427089 · DOI 10.3390/biomedicines13051262