Electrical Stimulation for Nerve Injury Recovery

Overseen By Ming Chan, MB ChB

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Other neurologic conditions, cognitive compromise, minors

Compensation: Varies

Number of Visits: 9

Duration: 1 day

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary goal of this study is to quantify the functional deficits caused by injuries to the brachial plexus and peripheral nerve in the arm. The second goal is to test the possible benefit of electrical stimulation of the injured nerve following surgery. The investigators will test whether electrical stimulation will improve hand function and nerve regeneration after repair for nerve injury. Injuries causing nerve damage in the arm and hand are common. In severe cases, functional outcomes even with surgery remain poor. Recently, electrical stimulation has been applied to injured nerves in rats. This was shown to improve nerve regeneration. These studies showed that as little as one hour of electrical stimulation was effective. Therefore, the investigators plan to test this new method of treatment to determine whether it is also helpful in humans. These will be done by using a symptom severity questionnaire, nerve conduction studies and by testing pressure sensations, hand dexterity and strength. The patients will be randomized to either the treatment or control group. Following the treatment, all baseline measurements will be reevaluated every three months for the first year and every 6 months during the second year. The timing and nature of the evaluation process will be identical in both groups.

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 data supports the effectiveness of the treatment Post surgical electrical stimulation for nerve injury recovery?

Research shows that brief post-surgical electrical stimulation can speed up nerve healing and improve function after surgery. It has been effective in both animal studies and human trials, helping nerves grow back and reconnect better, especially in cases of severe nerve damage. ^{1 2 3 4 5}

Is electrical stimulation for nerve injury recovery safe for humans?

Research indicates that electrical stimulation for nerve injury recovery has been tested in humans and is considered safe, with several clinical trials supporting its use. While detailed safety data is limited, the technique has been used in various applications, suggesting a general safety profile for human use. ^{1 2 3 6 7}

How does electrical stimulation differ from other treatments for nerve injury recovery?

Electrical stimulation is unique because it uses low-frequency electrical currents applied during or after surgery to enhance nerve regeneration. This method accelerates axon growth and reinnervation, potentially improving recovery outcomes compared to traditional surgical treatments alone. ^{1 2 3 8 9}

Research Team

Ming Chan, MB ChB

Principal Investigator

University of Alberta

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

Group I: Post surgical electrical stimulation Active Control 1 Intervention

Balanced AC pulse at 20 Hz with less than 30V and 0.01 ms duration will be delivered for 1 hour.

Group II: Sham stimulation Placebo Group 1 Intervention

Stimulation with the same parameters delivered only for 5 s.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation to enhance peripheral nerve regeneration: Update in molecular investigations and clinical translation. Zuo, KJ., Gordon, T., Chan, KM., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Electrical Stimulation Promotes Nerve Regeneration Following Experimental In-Continuity Nerve Injury. Shapira, Y., Sammons, V., Forden, J., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of long-term electrical peripheral nerve stimulation: review of the state of the art. Günter, C., Delbeke, J., Ortiz-Catalan, M.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Electrical stimulation to enhance peripheral nerve regeneration: Update in molecular investigations and clinical translation. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The use of brief post-surgical low frequency electrical stimulation to enhance nerve regeneration in clinical practice. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Timing of applying electrical stimulation is an important factor deciding the success rate and maturity of regenerating rat sciatic nerves. [2010]

4. Scotland pubmed.ncbi.nlm.nih.gov

Direct electrical stimulation on the injured ulnar nerve using acupuncture needles combined with rehabilitation accelerates nerve regeneration and functional recovery-A case report. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Brief Electrical Stimulation Promotes Nerve Regeneration Following Experimental In-Continuity Nerve Injury. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Safety of long-term electrical peripheral nerve stimulation: review of the state of the art. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Electrical Stimulation on Nerve Regeneration Following Peripheral Nerve Injury. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Effect of short-term low-frequency electrical stimulation on nerve regeneration of delayed nerve defect during operation]. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Influence of surface peripheral electrical stimulation on nerve regeneration after digital nerve neurorrhaphy: study protocol for a randomized clinical trial. [2022]