Electrical Stimulation for Spinal Cord Injury

Overseen By Monica Gorassini, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Severe head injury, autonomic dysreflexia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electrical stimulation, specifically TENS (transcutaneous electrical nerve stimulation), can help manage muscle tightness and improve muscle control in people with spinal cord injuries. Researchers aim to compare the effects of TENS against not using it initially to observe its impact over time. Participants will either begin TENS treatment immediately or after a two-month wait. Adults with a spinal cord injury between the C5 and T12 vertebrae, who do not have severe head injuries or other conflicting conditions, might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future treatment options for spinal cord injuries.

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 prior data suggests that this electrical stimulation technique is safe for spinal cord injury?

Research has shown that TENS (Transcutaneous Electrical Nerve Stimulation) is generally safe for individuals with spinal cord injuries. Studies have found that TENS can safely help manage pain and aid in recovery for these individuals. Participants in these studies reported no serious side effects, indicating that TENS is well-tolerated. Some people might feel a mild tingling during TENS, but it is usually not uncomfortable. Overall, the evidence supports the safety of TENS for treating spinal cord injuries, making it a promising option for those considering joining clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of TENS (Transcutaneous Electrical Nerve Stimulation) for spinal cord injury because it offers a non-invasive and drug-free approach to managing symptoms. Unlike standard treatments, which often include medications and physical therapy, TENS works by delivering electrical impulses that may help modulate nerve activity and reduce pain. This method is appealing because it targets the condition at a neurological level without the side effects associated with medications. Additionally, TENS can be easily administered using portable devices, making it a convenient option for ongoing management outside of clinical settings.

What evidence suggests that TENS is effective for spinal cord injury?

Research shows that transcutaneous electrical nerve stimulation (TENS) can help with various issues after a spinal cord injury. Studies have found it may reduce muscle stiffness and improve control over voluntary movements. Some patients have reported better control and stability of their upper body, improved leg function, and even enhanced ability to stand. TENS has also effectively reduced pain during treatment. In this trial, participants in the intervention group will receive TENS immediately upon entry, while the control group will receive TENS after a 2-month delay. Overall, these findings suggest that TENS could offer significant benefits for people with spinal cord injuries. ^{5 6 7 8 9}

Who Is on the Research Team?

Monica A Gorassini, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• TENS

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 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 Group Active Control 1 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).

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

Only 30% of the 40 reviewed clinical trials on acute spinal cord injury provided satisfactory reporting of adverse events, indicating a significant gap in safety information that is crucial for assessing risk and designing future studies.

A staggering 82.5% of trials failed to report laboratory-defined toxicity satisfactorily, highlighting the need for improved standards in safety reporting to ensure comprehensive understanding of treatment risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. Aspinall, P., Harrison, L., Scheuren, P., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation in spinal cord injury. Sadowsky, CL.[2006]

In a study of 8326 patients who underwent spinal cord stimulation (SCS) implantation, the overall incidence of spinal cord injury (SCI) was found to be low at 2.13%, indicating that SCS is a generally safe procedure.

There was no significant difference in the rates of SCI or spinal hematoma between patients receiving percutaneous (2.35%) and paddle (1.71%) electrode implantation, suggesting similar safety profiles for both methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. Petraglia, FW., Farber, SH., Gramer, R., et al.[2022]

In a study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Military concerns for chronic pain stimulator devices. Hughey, S., Field, R., Campbell, D., et al.[2023]

Electrical stimulation significantly enhances the proliferation and differentiation of spinal cord-derived neural stem/progenitor cells (SC-NSPCs) in both in vitro and in vivo rodent models of spinal cord injury (SCI), leading to improved functional recovery.

The mechanism behind these benefits appears to involve the activation of the Wnt/β-catenin signaling pathway, suggesting that electrical stimulation could be a promising noninvasive treatment strategy for promoting neural regeneration after SCI.

NCBI (Pubmed)

pubmed.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. Bang, WS., Han, I., Mun, SA., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation. Golovlev, AV., Hillegass, MG.[2020]

Citations

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Efficacy of transcutaneous electrical nerve stimulation in ... Transcutaneous electrical nerve stimulation has some clinical therapeutic effects on persons with pain after spinal cord injury.

2. probiologists.com probiologists.com/article/exploring-the-effects-of-transcutaneous-electrical-nerve-stimulation-tens-in-spinal-cord-injury-rehabilitation-a-systematic-review-of-systematic-reviews

Exploring the effects of transcutaneous electrical nerve ... TENS showed promising effects for various rehabilitative purposes, including spasticity, pain, motor function, erectile function, and cognitive function

3. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2021.740307/full

Transcutaneous Electrical Spinal Cord Stimulation to ... Enhanced trunk control and stability (9), improved lower extremity (LE) function, locomotor output, and standing (6, 8, 13) as well as reduced ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2746624/

Effectiveness of Transcutaneous Electrical Nerve Stimulation ... These clinically important results suggest that high-frequency TENS had its greatest effects on pain reduction during the 6 weeks of treatment. Low-frequency ...

5. urotoday.com urotoday.com/recent-abstracts/pelvic-health-reconstruction/neurogenic-bladder/146555-transcutaneous-electrical-stimulation-for-neurogenic-bladder-after-spinal-cord-injury-a-systematic-review-and-meta-analysis.html

A Systematic Review and Meta-Analysis. This review aims to assess the efficacy of transcutaneous electrical nerve stimulation (TENS) for neurogenic bladder after spinal cord ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39893085/

Cardiovascular safety of transcutaneous spinal cord ... This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925000066

Cardiovascular safety of transcutaneous spinal cord ... This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury.

8. nature.com nature.com/articles/s41393-022-00776-z

Efficacy of transcutaneous electrical nerve stimulation in ... Transcutaneous electrical nerve stimulation has some clinical therapeutic effects on persons with pain after spinal cord injury.

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN240014.pdf

Transcutaneous electrical spine stimulator to improve skeletal ... The study enrolled adults (at least 22 years of age) who had experienced a C2-C8 incomplete spinal cord injury (SCI) at least 12 months prior and had.