NCT05801536

TCES for Upper Limb Function in Cervical SCI

Completed NA Last updated 20 June 2024

What this trial tests

NA trial testing SCONE in Spinal Cord Injuries in 5 participants. Completed in 1 May 2024.

Timeline

13 June 2022

Primary endpoint
1 May 2024

1 May 2024

Quick facts

Lead sponsor	University of Leeds
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	13 June 2022
Primary completion	1 May 2024
Estimated completion	1 May 2024
Sites	1 location across United Kingdom

Drugs / interventions tested

• SCONE

Conditions studied

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

Sponsor

University of Leeds

Who can join

Adults 18 to 80, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Following a cervical spinal cord injury (cSCI; damage to the spinal cord at the neck) there is catastrophic loss of hand and grip function. This has a devastating effect on quality of life and functional independence. Thus, there is a real need to identify and optimise therapy to aid functional arm and hand recovery. One such therapy is Transcutaneous Electrical Stimulation (tCES). This involves applying sticky pads to the skin and then transmitting a low-level electrical current to the spinal cord. This activates neural circuits, allowing injured nerves to transmit signals to muscles to produce movement while completing upper limb tasks. The purpose of this pilot project is to establish if and how tCES might be used to improve arm and hand control. The investigators will recruit 8 people who have had a cSCI for \>1yr. First, the investigators will invite volunteers to the University for 2 weeks, twice per week, to establish their baseline movement capacity.

Then the investigators will allocate the volunteers to one of two groups: group 1 will undertake 4 weeks of upper limb task practice (ULTP) followed by 4 weeks of ULTP+tCES; group 2 will undertake ULTP+tCES for 4 weeks followed by 4 weeks of ULTP. Participants will then complete a week (2 sessions) of post-intervention assessment. The investigators will then invite volunteers and carers to be interviewed about their experiences of being involved in the project. Finally, there will be 2 sessions of follow-up assessment after 3 months. In order to assess if and how ULTP+tCES affects arm and hand control the investigators will measure: movement capacity using standard clinical tests; muscular activity in response to brain/spinal stimulation; how fast and smooth movements are when reaching and grasping objects. The investigators will also examine how the intervention has affected Quality of Life (QoL) and independence (Spinal Cord Independence Measure).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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