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Electrical Stimulation for Spinal Cord Injury

N/A

Waitlist Available

Led By Monica Gorassini, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Severe head injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre intervention. 1, 2 and 4 months follow up. in addition, spasticity will be measured every 2 weeks to assess stability of the effects.

Awards & highlights

No Placebo-Only Group

Summary

This trialexamines the effects of TENS on spasticity & force control in spinal cord injury. Modified Ashworth Score & pendulum test used, electrophysiological measures to assess motorneuron activity. Intervention group gets 2 months of TENS, control group 2 months later.

Who is the study for?

Adults over 18 with spinal cord injuries between the neck and mid-back (C5-T12 levels) can join this trial. It's not for those who've had a severe head injury, uncontrolled blood pressure spikes due to nerve issues (autonomic dysreflexia), or conditions that make TENS unsafe.

What is being tested?

The study is testing if lumbosacral TENS, an electrical stimulation therapy, can reduce muscle stiffness (spasticity) and improve voluntary muscle control in people with spinal cord injuries. One group gets TENS for two months; another waits two months before receiving it.

What are the potential side effects?

TENS is generally safe but may cause skin irritation under the pads, tingling sensations during use, or muscle twitching. Rarely, it might lead to discomfort or pain at the stimulation site.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a severe head injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre intervention. 1, 2 and 4 months follow up. in addition, spasticity will be measured every 2 weeks to assess stability of the effects.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre intervention. 1, 2 and 4 months follow up. in addition, spasticity will be measured every 2 weeks to assess stability of the effects.

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre intervention. 1, 2 and 4 months follow up. in addition, spasticity will be measured every 2 weeks to assess stability of the effects. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Modified Ashworth Score

Secondary study objectives

Change in EMG

Change in International Standard for Neurological Classification of SCI (ISNCSI)

Change in Knee Pendulum Angle

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

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.

Group II: Control GroupActive Control1 Intervention

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).

0 / 1Eligibility criteria met