Electrical Stimulation for Nerve Damage

(FASTR-TEN Trial)

Recruiting at 1 trial location

Overseen By Director of Clincal Reseach

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Checkpoint Surgical Inc.

Disqualifiers: Arrhythmia, Congestive heart failure, Neuropathy, others

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.

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 Brief Electrical Stimulation Therapy for nerve damage?

Research shows that brief electrical stimulation can help nerves heal faster and improve recovery after injuries. Studies in both humans and animals have found that this treatment can speed up nerve growth and improve function, making it a promising option for nerve damage recovery. ^{1 2 3 4 5}

Is electrical stimulation therapy safe for humans?

A review on the safety of electrical stimulation for peripheral nerves in humans suggests that while it is used in various applications, detailed safety data is limited, especially for long-term use. However, the review indicates that understanding stimulation parameters and their effects is crucial for safe application. ^{2 3 6 7 8}

How does Brief Electrical Stimulation Therapy differ from other treatments for nerve damage?

Brief Electrical Stimulation Therapy is unique because it involves applying short bursts of electrical currents directly to the nerve, which can enhance nerve regeneration and functional recovery, especially in cases where the nerve is still intact but not fully functional. This approach is different from other treatments that may not directly target nerve regeneration or use electrical currents in this specific manner. ^{3 4 9 10 11}

Eligibility Criteria

This trial is for adults aged 18-80 who need surgical repair of a digital nerve with a gap ≤10mm after resection. Candidates must be able to undergo surgery under general anesthesia and complete tension-free direct repair or use conduits/grafts ≤15mm.

Inclusion Criteria

I have signed the consent form for the trial.

I am fit for surgery under general anesthesia.

I need surgery to fix a nerve injury in my finger.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Repair and Treatment

Participants undergo surgical repair of digital nerve injury with or without a 10-minute dose of therapeutic electrical stimulation

1 day

Follow-up

Participants are monitored for sensory function and pain using various tests

9 months

Treatment Details

Interventions

• Brief Electrical Stimulation Therapy

Trial Overview The study tests if electrical stimulation therapy during digital nerve repair surgery can accelerate healing. Participants will receive this treatment at the time of their scheduled surgical procedure.

Participant Groups

Group I: Repair + Therapy Experimental Treatment 2 Interventions

During the surgical repair for digital nerve injury (standard of care), a 10 minute dose of therapeutic electrical stimulation will be delivered during surgery.

Group II: Standard of Care Repair Active Control 1 Intervention

Individuals will receive standard of care surgical repair of their digital nerve injury as determined by their surgeon.

Who Is Running the Clinical Trial?

Checkpoint Surgical Inc.

Lead Sponsor

Trials

3

Recruited

220+

Findings from Research

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]

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]

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]

A pilot study involving patients with painful diabetic neuropathy showed that pulsed-dose electrical stimulation significantly reduced pain levels over a 4-week treatment period, as measured by a visual analog scale.

This study is the first to report on the use of a knitted silver-plated stocking electrode for delivering electrical stimulation, suggesting it may be an effective method for alleviating burning pain in diabetic neuropathy patients with intact protective sensation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is electrical stimulation effective in reducing neuropathic pain in patients with diabetes? Armstrong, DG., Lavery, LA., Fleischli, JG., et al.[2019]

References

1. 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]

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

Short-Duration, Pulsatile, Electrical Stimulation Therapy Accelerates Axon Regeneration and Recovery following Tibial Nerve Injury and Repair in Rats. [2023]

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

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

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

Short-term electrical stimulation to promote nerve repair and functional recovery in a rat model. [2015]

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

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

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

Direct current electrical stimulation of acupuncture needles for peripheral nerve regeneration: an exploratory case series. [2011]

7. England pubmed.ncbi.nlm.nih.gov

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

8. France pubmed.ncbi.nlm.nih.gov

Electrical stimulation accelerates nerve regeneration and functional recovery in delayed peripheral nerve injury in rats. [2013]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Current-modulated electrical stimulation as a treatment for peripheral nerve regeneration in diabetic rats. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Electrical Stimulation in Clinical Practice. [2019]

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

Is electrical stimulation effective in reducing neuropathic pain in patients with diabetes? [2019]