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
NOT_YET_RECRUITING
Clinical Phase
EARLY_PHASE1
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-11-30
Study Completion Date
2027-12-31
Brief Summary
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Regaining hand and arm function is an important step towards regaining independence following high-level spinal cord injury (tetraplegia). The delivery of small electrical pulses over the skin above the spinal cord, called transcutaneous spinal cord stimulation (tESCS), appears to improve the arm and hand function of people who have had tetraplegia for several years when delivered at the same time as upper limb therapy. However, tESCS has not been tested in people who have a new spinal cord injury. It should be straightforward to deliver tESCS during standard upper limb therapy sessions to inpatients receiving primary rehabilitation. The investigators want to test the practical aspects of delivering this intervention and also to compare recovery between a group of people who only receive upper limb therapy and a group who receive upper limb therapy and tESCS. If successful, tESCS could in the future be used as part of regular therapy following an acute spinal cord injury. Benefits could include faster and better recovery, reduced stay in hospital, and reduced NHS costs.
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Detailed Description
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Background Spinal Cord Injury affects more than 50,000 people in the UK, with an incidence of 2400 new cases every year. Muscular paralysis and sensory loss carry substantial physiological, psychological, financial, and social costs. Almost 60% of people affected by SCI sustain a high-level injury, that is, injury to spinal levels C2-T1, affecting arms and hands. Restoring hand and arm function is a top priority for people with tetraplegia, where even small improvements of motor function, combined with available assistive devices, may greatly improve independence and quality of life.
Transcutaneous spinal cord stimulation (tESCS) has emerged as a viable neuromodulation approach for facilitating the recovery of motor function in people with SCI. Studies that have applied tESCS at cervical segments combined with activity-based upper limb rehabilitation. Such active-assisted exercises such as gross and fine motor skill training, maximum voluntary contraction training, and unimanual and bimanual task performance have shown significant improvements in upper limb function.
It is believed that tESCS stimulation activates motor neuronal networks of the spinal cord, including the recruitment of afferent fibres in the posterior root, to elevate spinal network excitability. The underlying hypothesis is that after severe cervical SCI, nonfunctional sensory-motor networks within the cervical spinal cord can be transcutaneously neuromodulated to physiological states that enable and amplify voluntary control of the arm and hand.
A multicentre ONWARD Up-LIFT trial, which included 14 research sites, including QENSIU, has demonstrated functional improvements in people with incomplete chronic tetraplegia. As part of a UK Neuromodulation Network, we were awarded funding to deliver a substantial follow-up study, focusing on chronic complete tetraplegia. The results are showing some neurological recovery but modest functional improvement, indicating that some minimal level of preserved sensory or motor function is required in order to benefit from tESCS. For that reason, the investigators plan to recruit people with incomplete SCI in this study.
Rationale In the area of upper limb rehabilitation, the focus has been mainly on people with chronic SCI, likely due to the lack of alternative rehabilitation strategies and the difficulty in applying acute interventions in the clinical setting \[3-8\]. However, to date, there have been limited studies reporting the use of tESCS with people with subacute SCI. A randomised controlled trial with 22 complete or incomplete tetraplegic patients (3-12 months post injury, probably recruited from home) compared 8 sessions of tESCS with Armeo robot exercise to 8 sessions of Armeo alone. Both groups achieved comparable functional improvement but Armeo group had a higher change in scores. Our recent search of ClinTrials.gov (search criteria Spinal Cord Injuries, Upper extremity dysfunctions and electrical stimulation) has however, identified no current or future study which includes people with subacute SCI and randomisation.
There are multiple technologies for people with subacute tSCI, including robotics, functional electrical stimulation, or more recently Brain Computer interface. Then, why do the investigators need yet another rehabilitation technology? There are several features that stand tESCS apart from the other rehabilitation technologies, both when it comes to usability and the mechanism of action. Most notably tSCI facilitates performing functional movements, therefore it can be combined with the existing therapy sessions, rather than requiring extra sessions like e.g. robotic devices or having multiple precisely defined stimulation sites like FES. Setup time is much shorter and the price is lower than robotics. This is of critical importance for the clinical adoption of technology, where lack of time in busy therapists' and patients' schedules is often a major barrier to larger-scale trials that would provide solid scientific evidence.
An obvious advantage of using tESCS in the subacute rather than in the chronic stage is the potential to supplement natural recovery. In addition, unused muscle has inevitably deconditioned in chronic SCI, therefore weeks of training to optimise muscle health is preferred prior to chronic tESCS intervention, which itself necessitates a large number of sessions. In one research study, the investigators identified requirements for (accompanied) transport and travel time to and from the hospital as the main factors impeding recruitment and increasing dropout rates in chronic patients. These are not issues for patients undergoing primary rehabilitation Finally, while months of tESCS training are required to achieve improvement in people with chronic SCI, it is not known whether this time would be substantially shorter in people undergoing primary rehabilitation post SCI and whether these benefits would be long-lasting.
Answering these questions and demonstrating the feasibility of delivering tESCS integrated with standard upper limb therapy would be major steps toward adopting this technology into clinical practice.
The investigators aim to test the feasibility of delivering tESCS to hospitalised (undergoing primary rehabilitation) tetraplegic patients by combining it with standard upper limb therapy. The investigators hypothesise that tESCS will be straightforward to implement and that it will not significantly burden staff or interrupt the existing patient schedule. The investigators also hypothesise that combining tESCS with conventional upper limb therapy will result in larger functional and neurological improvements than therapy alone.
Over 60% of people sustaining spinal cord injury have tetraplegia, resulting in a high level of disability. tESCS has shown very promising results in people with chronic injuries. Based on results from these studies, the investigators believe that tESCS has the potential to result.in substantial improvement in neurological recovery if delivered in parallel with primary rehabilitation.
This study will provide the first high quality evidence of the feasibility of incorporating tESCS into clinical practice in the acute care setting. Physical therapy/activity is an essential co-therapy of tESCS By combining tESCS with standard therapy, the additional burden on therapists will be minimised, increasing the chances of successful clinical translation of the technology.
the investigators hypothesise that the positive effect of tESCS will be greater in the acute/subacute than in the chronic phase and that therefore it would be possible to see significant improvement after only a few weeks of intervention. Improved neurological function should lead to a reduced length of stay and healthcare costs. The results of this study will be the first step towards a larger multicentre trial evaluating the early use of tESCS, a vital step towards wider adoption of tESCS in clinical settings. Such clinical adoption would have the potential to benefit all people with acute tetraplegia.
The efficient delivery of tESCS and the relative affordability of the device (costing under £10K they are much cheaper than robotic devices) greatly enhance the generalisability of the results for any future clinical trial.
Theoretical Framework It is believed that tESCS stimulation activates motor neuronal networks of the spinal cord, including the recruitment of afferent fibres in the posterior root, to elevate spinal network excitability. The underlying hypothesis is that after severe cervical SCI, nonfunctional sensory-motor networks within the cervical spinal cord can be transcutaneously neuromodulated to physiological states that enable and amplify voluntary control of the arm and hand
Transcutaneous spinal cord stimulation (tESCS) has emerged as a viable neuromodulation approach for facilitating the recovery of motor function in people with SCI. Studies that have applied tESCS at cervical segments combined with activity-based upper limb rehabilitation. Such active-assisted exercises such as gross and fine motor skill training, maximum voluntary contraction training, and unimanual and bimanual task performance have shown significant improvements in upper limb function.
It is believed that tESCS stimulation activates motor neuronal networks of the spinal cord, including the recruitment of afferent fibres in the posterior root, to elevate spinal network excitability. The underlying hypothesis is that after severe cervical SCI, nonfunctional sensory-motor networks within the cervical spinal cord can be transcutaneously neuromodulated to physiological states that enable and amplify voluntary control of the arm and hand.
A multicentre ONWARD Up-LIFT trial, which included 14 research sites, including QENSIU, has demonstrated functional improvements in people with incomplete chronic tetraplegia. As part of a UK Neuromodulation Network, we were awarded funding to deliver a substantial follow-up study, focusing on chronic complete tetraplegia. The results are showing some neurological recovery but modest functional improvement, indicating that some minimal level of preserved sensory or motor function is required in order to benefit from tESCS. For that reason, the investigators plan to recruit people with incomplete SCI in this study.
Rationale In the area of upper limb rehabilitation, the focus has been mainly on people with chronic SCI, likely due to the lack of alternative rehabilitation strategies and the difficulty in applying acute interventions in the clinical setting \[3-8\]. However, to date, there have been limited studies reporting the use of tESCS with people with subacute SCI. A randomised controlled trial with 22 complete or incomplete tetraplegic patients (3-12 months post injury, probably recruited from home) compared 8 sessions of tESCS with Armeo robot exercise to 8 sessions of Armeo alone. Both groups achieved comparable functional improvement but Armeo group had a higher change in scores. Our recent search of ClinTrials.gov (search criteria Spinal Cord Injuries, Upper extremity dysfunctions and electrical stimulation) has however, identified no current or future study which includes people with subacute SCI and randomisation.
There are multiple technologies for people with subacute tSCI, including robotics, functional electrical stimulation, or more recently Brain Computer interface. Then, why do the investigators need yet another rehabilitation technology? There are several features that stand tESCS apart from the other rehabilitation technologies, both when it comes to usability and the mechanism of action. Most notably tSCI facilitates performing functional movements, therefore it can be combined with the existing therapy sessions, rather than requiring extra sessions like e.g. robotic devices or having multiple precisely defined stimulation sites like FES. Setup time is much shorter and the price is lower than robotics. This is of critical importance for the clinical adoption of technology, where lack of time in busy therapists' and patients' schedules is often a major barrier to larger-scale trials that would provide solid scientific evidence.
An obvious advantage of using tESCS in the subacute rather than in the chronic stage is the potential to supplement natural recovery. In addition, unused muscle has inevitably deconditioned in chronic SCI, therefore weeks of training to optimise muscle health is preferred prior to chronic tESCS intervention, which itself necessitates a large number of sessions. In one research study, the investigators identified requirements for (accompanied) transport and travel time to and from the hospital as the main factors impeding recruitment and increasing dropout rates in chronic patients. These are not issues for patients undergoing primary rehabilitation Finally, while months of tESCS training are required to achieve improvement in people with chronic SCI, it is not known whether this time would be substantially shorter in people undergoing primary rehabilitation post SCI and whether these benefits would be long-lasting.
Answering these questions and demonstrating the feasibility of delivering tESCS integrated with standard upper limb therapy would be major steps toward adopting this technology into clinical practice.
The investigators aim to test the feasibility of delivering tESCS to hospitalised (undergoing primary rehabilitation) tetraplegic patients by combining it with standard upper limb therapy. The investigators hypothesise that tESCS will be straightforward to implement and that it will not significantly burden staff or interrupt the existing patient schedule. The investigators also hypothesise that combining tESCS with conventional upper limb therapy will result in larger functional and neurological improvements than therapy alone.
Over 60% of people sustaining spinal cord injury have tetraplegia, resulting in a high level of disability. tESCS has shown very promising results in people with chronic injuries. Based on results from these studies, the investigators believe that tESCS has the potential to result.in substantial improvement in neurological recovery if delivered in parallel with primary rehabilitation.
This study will provide the first high quality evidence of the feasibility of incorporating tESCS into clinical practice in the acute care setting. Physical therapy/activity is an essential co-therapy of tESCS By combining tESCS with standard therapy, the additional burden on therapists will be minimised, increasing the chances of successful clinical translation of the technology.
the investigators hypothesise that the positive effect of tESCS will be greater in the acute/subacute than in the chronic phase and that therefore it would be possible to see significant improvement after only a few weeks of intervention. Improved neurological function should lead to a reduced length of stay and healthcare costs. The results of this study will be the first step towards a larger multicentre trial evaluating the early use of tESCS, a vital step towards wider adoption of tESCS in clinical settings. Such clinical adoption would have the potential to benefit all people with acute tetraplegia.
The efficient delivery of tESCS and the relative affordability of the device (costing under £10K they are much cheaper than robotic devices) greatly enhance the generalisability of the results for any future clinical trial.
Theoretical Framework It is believed that tESCS stimulation activates motor neuronal networks of the spinal cord, including the recruitment of afferent fibres in the posterior root, to elevate spinal network excitability. The underlying hypothesis is that after severe cervical SCI, nonfunctional sensory-motor networks within the cervical spinal cord can be transcutaneously neuromodulated to physiological states that enable and amplify voluntary control of the arm and hand
Conditions
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Spinal Cord Injuries (SCI)
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomised feasibility study The study design will be a randomised double blinded feasibility study. The investigators will recruit 20 participants, equally split into active and control interventions. The active group will receive upper limb therapy with transcutaneous spinal cord stimulation (tESCS) 1 hour per day, 5 days per week, for 4 weeks, while the control group will receive the same amount of sham therapy with tESCS electrodes placed as in the active group but with only 1 minute of electrical stimulation to achieve blinding.
Note that tESCS has a medical CE mark
Note that tESCS has a medical CE mark
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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Intervention
One hour of transcutaneous electrical stimulation alongside conventional occupational therapy
Group Type
EXPERIMENTAL
Transcutaneous spinal cord stimulation (tESCS) active group
Intervention Type
DEVICE
Participants in the active arm will receive 60 min of tESCS alongside the conventional occupation therapy, 20 sessions for 4 weeks, 5 times per week
Control
Receiving 1 minute of stimulation alongside the conventional occupational therapy
Group Type
SHAM_COMPARATOR
Sham transcutaneous spinal cord stimulation (tESCS)
Intervention Type
DEVICE
The control group will receive only 1 min of tESCS while doing conventional occupational therapy for 60 min. Number of session 20, 4 weeks, 5 times a week
Interventions
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Transcutaneous spinal cord stimulation (tESCS) active group
Participants in the active arm will receive 60 min of tESCS alongside the conventional occupation therapy, 20 sessions for 4 weeks, 5 times per week
Intervention Type
DEVICE
Sham transcutaneous spinal cord stimulation (tESCS)
The control group will receive only 1 min of tESCS while doing conventional occupational therapy for 60 min. Number of session 20, 4 weeks, 5 times a week
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Aged 18 years or over, both sexes.
* At least 6 weeks post-implant (in participants having a surgery for an implant to stabilise the spine).
* ISNCSCI upper extremity motor score between 5 and 30 (both arms/hands)
* GRASSP-strength score \>=15 \& \<70
* Medically stable, cognitively intact and able to breathe independently.
* Attending upper limb therapy sessions at the QENSIU
* Planned stay longer than the duration of the intervention
* Able to sit for more than 2 hours a day
* At least 6 weeks post-implant (in participants having a surgery for an implant to stabilise the spine).
* ISNCSCI upper extremity motor score between 5 and 30 (both arms/hands)
* GRASSP-strength score \>=15 \& \<70
* Medically stable, cognitively intact and able to breathe independently.
* Attending upper limb therapy sessions at the QENSIU
* Planned stay longer than the duration of the intervention
* Able to sit for more than 2 hours a day
Exclusion Criteria
* Unstable cervical spine injury
* Needing ventilation assistance during daytime
* Any implanted active metallic device without unconfirmed MRI compatibility (in our previous studies, we safely applied tESCS to participants with MRI-compatible devices/implants)
* Pregnancy and/or lactation.
* Non-injury-related neurological impairment
* Severe spasticity which have been unstable prior to enrolment
* Botulinum toxin injections-
* Clinically significant severe depression
* Patients who have cardiovascular disease
* Patients with severe ongoing Autonomic Dysreflexia
* Skin conditions or allergies that may affect electrode placement.
* Current infections
* Patients who have been involved in any other interventional study
* Needing ventilation assistance during daytime
* Any implanted active metallic device without unconfirmed MRI compatibility (in our previous studies, we safely applied tESCS to participants with MRI-compatible devices/implants)
* Pregnancy and/or lactation.
* Non-injury-related neurological impairment
* Severe spasticity which have been unstable prior to enrolment
* Botulinum toxin injections-
* Clinically significant severe depression
* Patients who have cardiovascular disease
* Patients with severe ongoing Autonomic Dysreflexia
* Skin conditions or allergies that may affect electrode placement.
* Current infections
* Patients who have been involved in any other interventional study
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Glasgow
OTHER
Sponsor Role
collaborator
The Queen Elizabeth Hospital
OTHER
Sponsor Role
collaborator
NHS Greater Glasgow and Clyde
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Aleksandra Vuckovic University O VUCKOVIC, PhD Biomed Eng
Role: STUDY_DIRECTOR
School of Engineering, University of Glasgow
Mariel A Purcell, MB CHB BAO
Role: PRINCIPAL_INVESTIGATOR
NHS Greater Glasgow and Clyde
Locations
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Queen Elizabeth National Spinal Injuries Unit
Glasgow, , United Kingdom
Site Status
Countries
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United Kingdom
Central Contacts
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Facility Contacts
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References
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Han B, Enas NH, McEntegart D. Randomization by minimization for unbalanced treatment allocation. Stat Med. 2009 Nov 30;28(27):3329-46. doi: 10.1002/sim.3710.
Reference Type
BACKGROUND
Eldridge SM, Costelloe CE, Kahan BC, Lancaster GA, Kerry SM. How big should the pilot study for my cluster randomised trial be? Stat Methods Med Res. 2016 Jun;25(3):1039-56. doi: 10.1177/0962280215588242. Epub 2015 Jun 12.
Reference Type
BACKGROUND
Gawne F, Massey S, Duffell L. The Neurophysiological Effects of Cervical Transcutaneous Spinal Cord Stimulation With and Without a High Frequency Carrier in Able-Bodied Adults. Artif Organs. 2025 Jun 3. doi: 10.1111/aor.15031. Online ahead of print.
Reference Type
BACKGROUND
Salvador-De La Barrera S, Mora-Boga R, Ferreiro-Velasco ME, Seoane-Pillado T, Montoto-Marques A, Rodriguez-Sotillo A, Pertega Diaz S. A validity study of the Spanish-World Health Organization Quality of Life short version instrument in persons with traumatic spinal cord injury. Spinal Cord. 2018 Oct;56(10):971-979. doi: 10.1038/s41393-018-0139-2. Epub 2018 May 23.
Reference Type
BACKGROUND
Kirshblum SC, Burns SP, Biering-Sorensen F, Donovan W, Graves DE, Jha A, Johansen M, Jones L, Krassioukov A, Mulcahey MJ, Schmidt-Read M, Waring W. International standards for neurological classification of spinal cord injury (revised 2011). J Spinal Cord Med. 2011 Nov;34(6):535-46. doi: 10.1179/204577211X13207446293695. No abstract available.
Reference Type
BACKGROUND
McNicol EL, Osuagwu B, Purcell M, McCaughey EJ, Lincoln C, Cope L, Vuckovic A. Neurophysiological Effect of Transcutaneous Electrical Spinal Cord Stimulation in Chronic Complete Spinal Cord Injury. Artif Organs. 2025 Jun 30. doi: 10.1111/aor.15050. Online ahead of print.
Reference Type
BACKGROUND
Moritz C, Field-Fote EC, Tefertiller C, van Nes I, Trumbower R, Kalsi-Ryan S, Purcell M, Janssen TWJ, Krassioukov A, Morse LR, Zhao KD, Guest J, Marino RJ, Murray LM, Wecht JM, Rieger M, Pradarelli J, Turner A, D'Amico J, Squair JW, Courtine G. Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial. Nat Med. 2024 May;30(5):1276-1283. doi: 10.1038/s41591-024-02940-9. Epub 2024 May 20.
Reference Type
BACKGROUND
Barss TS, Parhizi B, Porter J, Mushahwar VK. Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. J Clin Med. 2022 Jan 27;11(3):639. doi: 10.3390/jcm11030639.
Reference Type
BACKGROUND
Chandrasekaran S, Bhagat NA, Ramdeo R, Ebrahimi S, Sharma PD, Griffin DG, Stein A, Harkema SJ, Bouton CE. Targeted transcutaneous spinal cord stimulation promotes persistent recovery of upper limb strength and tactile sensation in spinal cord injury: a pilot study. Front Neurosci. 2023 Jul 7;17:1210328. doi: 10.3389/fnins.2023.1210328. eCollection 2023.
Reference Type
BACKGROUND
McGeady C, Vuckovic A, Singh Tharu N, Zheng YP, Alam M. Brain-Computer Interface Priming for Cervical Transcutaneous Spinal Cord Stimulation Therapy: An Exploratory Case Study. Front Rehabil Sci. 2022 Jun 23;3:896766. doi: 10.3389/fresc.2022.896766. eCollection 2022.
Reference Type
BACKGROUND
Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
Reference Type
BACKGROUND
Freyvert Y, Yong NA, Morikawa E, Zdunowski S, Sarino ME, Gerasimenko Y, Edgerton VR, Lu DC. Engaging cervical spinal circuitry with non-invasive spinal stimulation and buspirone to restore hand function in chronic motor complete patients. Sci Rep. 2018 Oct 19;8(1):15546. doi: 10.1038/s41598-018-33123-5.
Reference Type
BACKGROUND
Gad P, Lee S, Terrafranca N, Zhong H, Turner A, Gerasimenko Y, Edgerton VR. Non-Invasive Activation of Cervical Spinal Networks after Severe Paralysis. J Neurotrauma. 2018 Sep 15;35(18):2145-2158. doi: 10.1089/neu.2017.5461.
Reference Type
BACKGROUND
Khorasanizadeh M, Yousefifard M, Eskian M, Lu Y, Chalangari M, Harrop JS, Jazayeri SB, Seyedpour S, Khodaei B, Hosseini M, Rahimi-Movaghar V. Neurological recovery following traumatic spinal cord injury: a systematic review and meta-analysis. J Neurosurg Spine. 2019 Feb 15;30(5):683-699. doi: 10.3171/2018.10.SPINE18802. Print 2019 May 1.
Reference Type
BACKGROUND
Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
Reference Type
BACKGROUND
Other Identifiers
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SMSR009
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GN24NE012
Identifier Type: -
Identifier Source: org_study_id
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