Electrical Stimulation for Spasticity in Spinal Cord Injury

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05103436
Study type	Interventional
Source	University of Alberta
Contact
Status	Active, not recruiting
Phase	N/A
Start date	May 4, 2022
Completion date	December 31, 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.