tESCS for Upper Limb Rehab in Spinal Cord Injury

NCT07208188 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: GN24NE012SMSR009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries (SCI)

Keywords

Tetraplegia; incomplete; subacute; transcutaneous spinal cord stimulation; randmised feasibility study

Outcome Measures

Primary Outcomes (5)

• Retention

  Recruitment and retention

  From enrollment till the last assesment at 8 weeks

• Interference

  Interference with daily routine

  From enrolment till the end of intervention at 4 weeks

• Stimulation

  Optimal current stimulation intensity in mA

  From the first till the last intervention session at 4 weeks

• Adverse effects

  The number of adverse effects

  from the first till the last intervention session at 4 weeks

• Feedback

  Semi structured interview

  From enrolment till the last assesment at 8 weeks

Secondary Outcomes (10)

• Hand function

  From the first intervention session till the last assesment at 8 weeks

• Spinal Cord Independence Measure

  From the recruitment till the last assessment at 8 weeks

• Quality of life basic dataset

  From recruitment till the last assessment at 8 weeks

• Spasticity

  From the enrolment till the last assesment at 8 weeks

• Dynamometry

  From the enrolment till the last assesment at 8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

One hour of transcutaneous electrical stimulation alongside conventional occupational therapy

Device: Transcutaneous spinal cord stimulation (tESCS) active group

Control

SHAM COMPARATOR

Receiving 1 minute of stimulation alongside the conventional occupational therapy

Device: Sham transcutaneous spinal cord stimulation (tESCS)

Interventions

Transcutaneous spinal cord stimulation (tESCS) active group 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

Intervention

Sham transcutaneous spinal cord stimulation (tESCS) 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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator
• The Queen Elizabeth Hospital: collaborator

Study Sites (1)

Queen Elizabeth National Spinal Injuries Unit

Glasgow, G51 4TF, United Kingdom

Location

Related Publications (15)

• 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.

  PMID: 19739238 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.

  PMID: 26071431 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.

  PMID: 40457929 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.

  PMID: 29795170 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.

  PMID: 22330108 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.

  PMID: 40583777 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.

  PMID: 38769431 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.

  PMID: 35160091 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.

  PMID: 37483349 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.

  PMID: 36188944 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.

  PMID: 29877852 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.

  PMID: 30341390 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.

  PMID: 29649928 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.

  PMID: 30771786 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.

  PMID: 15672628 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aleksandra Vuckovic University O VUCKOVIC, PhD Biomed Eng

  School of Engineering, University of Glasgow

  STUDY DIRECTOR

• Mariel A Purcell, MB CHB BAO

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariel A Purcell, MB CHB BAO

CONTACT

+44 141 201 2536; Margaret.Purcell@ggc.scot.nhs.uk

ALEKSANDRA VUCKOVIC, PhD Biomed Eng

CONTACT

+447906441955; aleksandra.vuckovic@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: October 6, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1st January 2029
• Access Criteria: Researchers contacting Professor Vuckovic or Dr Purcell. Data will not be publicly available on any site

Locations

GB (1)