Electrical Stimulation for Spasticity in Spinal Cord Injury

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: TENS

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2E1
      • University of Alberta - 524 HMRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• SCI adults 18 years and older
• injury levels between C5-T12

Exclusion Criteria:

• severe head injury
• uncontrolled autonomic dysreflexia
• other medical conditions precluding TENS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Participants will not receive intervention for the first 2 months. This period will be used for comparison with the intervention group. At the end of the 2-month delay, they will receive TENS (1 hr AM, 1 hr PM/day, 50 Hz, below pain/motor threshold, using an EMS 7500 TENS unit).
Experimental: Intervention Group; Participants will receive 2 months of TENS (1 hr AM, 1 hr PM/day, 50 Hz, below pain/motor threshold, using an EMS 7500 TENS unit) immediately upon entry to the study.	Other: TENS; Electrical nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Modified Ashworth Score	Clinical assessment of spasticity. Scores range from '0' to '4'. Minimum score is '0' meaning no increase in tone. Maximum score is '4' meaning limb is ridged in flexion and extension. The lower the score the better the outcome.	Pre Intervention. 1, 2 and 4 months follow up. In addition, spasticity will be measured every 2 weeks to assess stability of the effects.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knee Pendulum Angle	Clinical assessment of passive knee motion to assess spasticity.	Pre Intervention. 1, 2 and 4 months follow up.
Change in Manual Muscle Testing	Clinical assessment of muscle strength from grade '0' to '5', where '0' means no strength and '5' means normal strength.	Pre Intervention. 1, 2 and 4 months follow up.
Change in EMG	Assessment of motor control. Participants are asked to match their muscle contraction force to a target force profile. EMG data will be used to calculate the smoothness of muscle force.	Pre Intervention. 1, 2 and 4 months follow up.
Change in International Standard for Neurological Classification of SCI (ISNCSI)	Neurological Examination of participant. The Impairment Scale has 5 grades from A to E. Grade A is complete injury and grade E is normal. It is based on the strength of 10 key muscle groups in the upper and lower extremities, sensory response to light touch and pin prick at 28 key sensory points on each side of the whole body, and anal responses.	Pre Intervention. 1, 2 and 4 months follow up.

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Monica Gorassini, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: Pro00112681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only the investigators of this study and the University of Alberta Research Ethics Board will have access to participant information. Only de-identified data will be presented or published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No