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Active Not RecruitingNCT05103436

Electrical Stimulation for Spasticity in Spinal Cord Injury

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
University of Alberta · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study examines the immediate and long-term effects of lumbosacral TENS on spasticity and residual voluntary force control in spinal cord injury in comparison to no TENS. Participants in the intervention group will receive 2 months of TENS. Participants in the control group will receive TENS after a 2-month delay. Modified Ashworth score and pendulum test will be used to assess spasticity and force control. Electrophysiological measures will be used to assess the activity profile of motorneurons.

Detailed description

Transcutaneous electrical nerve stimulation (TENS) has been used to control pain in stroke, MS, cerebral palsy and spinal cord injury (SCI) and its effect on spasticity reduction, although not used clinically, has been examined recently. In the few SCI studies done to date, the TENS electrodes have been placed on the nerve to the muscle under study and initial reports show a consistent decrease in spasticity measures, like the Modified Ashworth Score (MAS) and reflexes, during or hours after the TENS application. Recently, study team members from the ReYu Recovery Centre in Edmonton have observed that when TENS is applied with both electrodes over the lower back (lumbosacral TENS), varying amounts of immediate and long-term spasticity relief are produced in both legs. The investigators have observed 3 clients from ReYU and all have shown immediate reductions in spasticity for at least 2 joints in both legs. The effect of the lumbosacral TENS varied from an immediate dramatic reduction to a more moderate reduction when applied over several days. This study will examine the immediate and longer-term (2 months) effect of using spinal TENS in reducing spasticity of the lower limbs in a larger number of participants with SCI. The investigators want to understand how spinal TENS affects spinal circuits and motoneurons below the lesion to reduce spasticity to observe improvement in its effect in those with more moderate responses. Lumbosacral TENS has the potential for a non-pharmacological, on-demand control of SCI spasticity to greatly improve the quality of life of those affected.

Conditions

Interventions

TypeNameDescription
OTHERTENSElectrical nerve stimulation

Timeline

Start date
2022-05-04
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2021-11-02
Last updated
2026-01-08

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT05103436. Inclusion in this directory is not an endorsement.