80 Participants Needed

Electrical Stimulation for Nerve Injury Recovery

MC
Overseen ByMing Chan, MB ChB
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether electrical stimulation can aid recovery after surgery for nerve injuries in the arm and hand. Researchers aim to determine if this method can improve hand function and promote nerve healing. Participants will receive either real electrical stimulation (post-surgical electrical stimulation) or a placebo (fake treatment), with regular progress assessments. Suitable candidates for this trial have severe brachial plexus injuries, resulting in complete nerve loss in the arm. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance recovery options for future patients.

Do I need to stop my current medications for the trial?

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 method is safe for nerve injury recovery?

Research has shown that electrical stimulation might help nerves heal better after an injury. In animal studies, even just one hour of electrical stimulation helped nerves grow back. For people, studies have demonstrated that those who received electrical stimulation recovered better than those who did not, regaining more feeling and movement in the injured area.

Safety remains a key focus in these studies. So far, no serious side effects have been reported with the use of electrical stimulation for nerve injuries, suggesting it is generally well-tolerated. For those considering joining a trial involving electrical stimulation, existing research supports its potential benefits and indicates it is generally safe for humans.12345

Why are researchers excited about this trial?

Researchers are excited about post-surgical electrical stimulation for nerve injury recovery because it offers a novel approach by using electrical pulses to potentially speed up nerve healing. Unlike traditional methods like physical therapy and medications, which can take a long time to show results, this technique uses a balanced AC pulse at a specific frequency and voltage to directly stimulate nerve regeneration. The possibility of delivering effective therapy in just one hour of treatment is a significant advantage, making it a promising option for quicker recovery.

What evidence suggests that electrical stimulation is effective for nerve injury recovery?

Research has shown that electrical stimulation can enhance nerve healing after surgery. In this trial, participants will receive either post-surgical electrical stimulation or sham stimulation. Studies have found that nerves treated with electrical stimulation had a 75% chance of recovery, with some patients reporting feeling almost normal in just six months. Another study observed that people who received electrical stimulation recovered better than those who did not. This suggests that electrical stimulation might aid nerve regrowth and improve hand function after an injury.23567

Who Is on the Research Team?

MC

Ming Chan, MB ChB

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for adults with severe brachial plexus injuries, which have led to complete loss of nerve function in the arm. Participants must be able to understand and consent to the study's procedures. It excludes minors, individuals with cognitive impairments that affect their understanding of the study, or those with other neurological conditions.

Inclusion Criteria

I have a severe arm nerve injury with total loss of movement or feeling.

Exclusion Criteria

I am able to understand and consent to the study on my own.
I am under 18 years old.
The presence of other neurologic conditions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo nerve repair/transfer surgery followed by either sham stimulation or 1 hour of electrical stimulation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations every 3 months for the first year and every 6 months during the second year

24 months
8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Post surgical electrical stimulation
Trial Overview The trial is examining if post-surgical electrical stimulation can improve hand function and nerve regeneration after an arm nerve injury repair surgery. Patients will be randomly assigned to either receive this treatment or be in a control group, with follow-up evaluations over two years.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Post surgical electrical stimulationActive Control1 Intervention
Group II: Sham stimulationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Published Research Related to This Trial

Low frequency electrical stimulation applied during surgery for peripheral nerve injuries can significantly enhance recovery by promoting axon outgrowth and remyelination, potentially improving functional outcomes for patients.
Recent randomized clinical trials provide strong evidence supporting the use of electrical stimulation as a safe and effective adjunct to surgical repair, making it a promising option for improving recovery in patients with nerve injuries.
Electrical stimulation to enhance peripheral nerve regeneration: Update in molecular investigations and clinical translation.Zuo, KJ., Gordon, T., Chan, KM., et al.[2021]
Extraneural electrodes are more stable for long-term use compared to intraneural electrodes, which is important for the safety of chronic electrical stimulation applications.
Current guidelines suggest that chronic stimulation should be kept below 30 Hz and effective stimulation time below 50% to minimize risks, but more comprehensive data is needed to establish safe stimulation protocols.
Safety of long-term electrical peripheral nerve stimulation: review of the state of the art.Gรผnter, C., Delbeke, J., Ortiz-Catalan, M.[2021]
In a study involving Lewis rats with neuroma-in-continuity injuries, brief electrical stimulation (ES) applied immediately after injury led to faster recovery and significantly improved locomotion function at 4 and 6 weeks compared to controls.
Although the benefits of brief ES diminished by 12 weeks, histomorphological analysis showed a greater percentage of neural tissue and a preference for motor nerve regeneration in the ES group, suggesting potential for this therapy in human nerve injuries.
Brief Electrical Stimulation Promotes Nerve Regeneration Following Experimental In-Continuity Nerve Injury.Shapira, Y., Sammons, V., Forden, J., et al.[2020]

Citations

The Effect of Electrical Stimulation on Nerve Regeneration ...Using retrograde labeling, investigators found that after a three-month delay in repair, ES improved both sensory and motor neuron counts [19].
The Role of Electrical Stimulation in Peripheral Nerve ...Impressively, recovery after electrical stimulation led to a near-normal sensation by 6 months after surgery. Evidence in Animal Models of Nerve Gaps. No human ...
Mount Sinai Researchers Find Electrical Stimulation May ...Conversely, nerves that did respond to stimulation had a 75 percent probability of recovery. In summary, researchers found that responsiveness ...
Clinical applications of electrical stimulation for peripheral ...Discussion: Patients who received electrical stimulation consistently demonstrated better recovery compared to their respective controls.
Does short-term intraoperative electrical stimulation ...The results suggest that intraoperative electrical stimulation following peripheral nerve repair accelerates and improves nerve regeneration ...
Electrical stimulation therapy for peripheral nerve injury - PMCLess than half of patients recover satisfactory motor and sensory function after nerve repair.
Intraoperative Electrical Nerve Stimulation as a Prognostic ...Intraoperative stimulation at 0.5 mA was observed in 73% (33/45) of nerves, with 76% achieving full recovery, 18% partial recovery, and 6% no recovery. Two ...
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