Clinical trial NCT05103436: Electrical Stimulation for Spasticity in Spinal Cord Injury
Official title: Electrical Stimulation for Spasticity in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either receive 2 months of TENS (1 hr AM, 1 hr PM/day, 50 Hz, below pain/motor threshold, using a EMS 7500 TENS unit) upon entry to the study (Intervention group) or not (Control; but offered the same TENS following a 2-month delay for equipoise).
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Modified Ashworth Score
timeFrame: 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 outcomes:
measure: Change in Knee Pendulum Angle
timeFrame: Pre Intervention. 1, 2 and 4 months follow up.
measure: Change in Manual Muscle Testing
timeFrame: Pre Intervention. 1, 2 and 4 months follow up.
measure: Change in EMG
timeFrame: Pre Intervention. 1, 2 and 4 months follow up.
measure: Change in International Standard for Neurological Classification of SCI (ISNCSI)
timeFrame: Pre Intervention. 1, 2 and 4 months follow up.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta - 524 HMRC
state: Alberta
Study officials:
affiliation: University of Alberta
name: Monica Gorassini, PhD
role: PRINCIPAL_INVESTIGATOR
References: