NCT03536338: Stim2Stand

Spinal Stimulation Sit-to-Stand Training After Spinal Cord Injury

Terminated NA Last updated 2 June 2020

What this trial tests

NA trial testing Spinal Stimulation in Spinal Cord Injuries in 9 participants. Terminated before completion.

Timeline

24 July 2018

Primary endpoint
23 March 2020

23 March 2020

Quick facts

Lead sponsor	University College, London
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	24 July 2018
Primary completion	23 March 2020
Estimated completion	23 March 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• Spinal Stimulation
• Sit-to-stand Training

Conditions studied

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

Sponsor

University College, London

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

An injury to the spinal cord can be life altering: with a 'complete' injury, the affected individual is unable to move their legs at all and may become wheelchair-bound. While a 'complete' injury suggests that the cord was completely severed, it is actually more common for some connections in the spinal cord to remain after it is injured but, for some reason, they are inactive or sleeping.

Electrical stimulation applied to the skin surface at the lower back appears to 'wake up' these remaining connections, allowing some (previously unavailable) leg movements. The first time they had this spinal stimulation (SS), people with long-standing 'complete' spinal cord injuries became able to move their legs and, after several weeks of SS, these movements seemed to increase. They also noticed other changes taking place, including improvements in their bladder control.

SS has been shown to cause strong leg extension movements, and one person with SCI stood up with SS, using minimal support. SS for standing may assist people with SCI to carry out daily tasks at home, which would hugely benefit the SCI community.

In this study we will explore whether SS enables people with SCI to stand up and whether regular sit-to-stand training combined with SS improves; i) standing ability; ii) bladder control and; iii) well-being, in people with SCI.

Ten volunteers with SCI will carry out an 8-week sit-to-stand training programme. Training will be carried out 3 times/week at Neurokinex using their Keiser Power Rack. The volunteers will be randomly assigned either to the control (sit-to-stand only) or test (sit-to-stand plus SS) group. Measurements will be taken before and after the training programme to assess standing ability, bladder function, and well-being.

Publications & conference data

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

1. The Effects of Adding Transcutaneous Spinal Cord Stimulation (tSCS) to Sit-To-Stand Training in People with Spinal Cord Injury: A Pilot Study.
   Al'joboori Y, Massey SJ, Knight SL, Donaldson NN, et al · · 2020 · cited 25× · PMID 32858977 · DOI 10.3390/jcm9092765
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