40 Participants Needed

Electrical Stimulation for Spinal Cord Injury

JD
MG
Overseen ByMonica Gorassini, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment TENS for spinal cord injury?

Research shows that TENS can effectively reduce pain and spasticity (muscle stiffness) in patients with spinal cord injuries. Studies found that TENS decreased pain levels and improved muscle control when added to physical therapy.12345

Is electrical stimulation for spinal cord injury generally safe for humans?

Spinal cord stimulation (SCS) has been used for over 40 years and is generally considered safe, with well-defined complication rates. However, some rare complications like new onset tinnitus and other neurological effects have been reported, and safety reporting in clinical trials for spinal cord injury is often suboptimal.678910

How does the treatment TENS differ from other treatments for spinal cord injury?

TENS (Transcutaneous Electrical Nerve Stimulation) is unique because it uses electrical currents to stimulate nerves through the skin, which can help manage pain and spasticity in spinal cord injury patients. Unlike other treatments, TENS is non-invasive and can promote neural regeneration by activating neural stem cells in the spinal cord.234511

Research Team

MG

Monica A Gorassini, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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.

Inclusion Criteria

I am an adult over 18 with a spinal cord injury.
Injury levels between C5-T12

Exclusion Criteria

I have had a severe head injury.
Uncontrolled autonomic dysreflexia
I do not have any health issues that prevent me from using TENS.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group receive 2 months of TENS immediately, while the control group receives TENS after a 2-month delay

2 months
Daily sessions (1 hr AM, 1 hr PM)

Follow-up

Participants are monitored for changes in spasticity and motor control using various assessments

4 months
Assessments at 1, 2, and 4 months

Treatment Details

Interventions

  • TENS
Trial OverviewThe 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.
Participant Groups
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Findings from Research

Electrical stimulation has a long history of use in medicine, and it shows great promise for treating various complications arising from spinal cord injuries, such as improving motor control and assisting with bodily functions.
Innovative applications of electrical stimulation are being explored for a wide range of functions in spinal cord injury patients, including enhancing cardiovascular fitness, aiding in breathing, and facilitating movement, which could significantly improve their quality of life.
Electrical stimulation in spinal cord injury.Sadowsky, CL.[2006]
Spinal cord stimulators (SCS) and peripheral nerve stimulators (PNS) are effective treatments for chronic pain, enabling many military service members to return to work and daily activities.
Despite potential environmental and occupational hazards faced by military personnel, the risk of complications from SCS and PNS devices remains low, indicating their safety in these challenging conditions.
Military concerns for chronic pain stimulator devices.Hughey, S., Field, R., Campbell, D., et al.[2023]
A patient experienced neurological complications, including tinnitus, vertigo, and facial twitches, after receiving a high-frequency spinal cord stimulator, which resolved upon deactivation of the device.
This case highlights the need for further research into the less common neurological side effects of spinal cord stimulation therapy, as current knowledge primarily focuses on surgical site infections and hardware issues.
New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation.Golovlev, AV., Hillegass, MG.[2020]

References

Efficacy of addition of transcutaneous electrical nerve stimulation to standardized physical therapy in subacute spinal spasticity: a randomized controlled trial. [2022]
Immediate effect of transcutaneous electrical nerve stimulation on spasticity in patients with spinal cord injury. [2022]
Effectiveness of transcutaneous electrical nerve stimulation in management of neuropathic pain in patients with post traumatic incomplete spinal cord injuries. [2022]
Electrical stimulation in spinal cord injury. [2006]
Effects of transcutaneous electrical nerve stimulation on pain in patients with spinal cord injury: a randomized controlled trial. [2020]
Military concerns for chronic pain stimulator devices. [2023]
New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation. [2020]
A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. [2023]
The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Electrical stimulation promotes functional recovery after spinal cord injury by activating endogenous spinal cord-derived neural stem/progenitor cell: an in vitro and in vivo study. [2023]