Electrical Stimulation for Nerve Damage

(FASTR-TEN Trial)

Recruiting at 4 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a short session of electrical stimulation during surgery can accelerate the healing of damaged nerves. It involves two groups: one receiving standard surgical care and the other receiving additional brief electrical stimulation therapy during surgery. Suitable candidates have had recent digital nerve injuries requiring surgical repair and must not have other nerve problems or severe health conditions that would prevent surgery. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance nerve healing techniques.

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 therapy is safe for nerve healing?

Research has shown that brief electrical stimulation during surgery is generally safe and well-tolerated. Some studies suggest that patients who received this stimulation recovered better than those who did not. One study found that this method is safe and easy to use, supporting its testing in larger trials. Although researchers continue to study this treatment, these findings suggest it is generally safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Brief Electrical Stimulation Therapy for nerve damage because it offers a novel approach during surgery. Unlike the standard surgical repair, which focuses solely on fixing the nerve, this therapy delivers a dose of electrical stimulation directly to the nerve during the procedure. This brief electrical pulse aims to accelerate nerve healing and improve recovery outcomes by enhancing nerve function right from the start. This innovative method could potentially speed up the healing process and lead to better functional recovery compared to traditional treatments.

What evidence suggests that Brief Electrical Stimulation Therapy is effective for nerve damage?

Research shows that brief electrical stimulation during surgery can enhance nerve healing. In this trial, participants in the "Repair + Therapy" arm will receive a 10-minute dose of therapeutic electrical stimulation during their standard surgical repair for digital nerve injury. Studies have found that this treatment encourages more nerve growth, aiding recovery. Patients who received electrical stimulation often recovered better than those who did not. Early evidence also suggests that this method is safe and easy to use. Overall, electrical stimulation appears promising for accelerating nerve repair. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9998520/

Electrical stimulation therapy for peripheral nerve injury - PMC This article aims to explore application methodologies for effective electrical stimulation in the rehabilitation of peripheral nerve injury.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589514124000525

The Role of Electrical Stimulation in Peripheral Nerve ... Early studies of direct electrical stimulation of nerves demonstrated an overall positive effect, with greater axon sprouting, more rapid muscle reinnervation,

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06867185

Evaluating Therapeutic Electrical Stimulation to Improve ... 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.

4. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1162851/full

Clinical applications of electrical stimulation for peripheral ... Discussion: Patients who received electrical stimulation consistently demonstrated better recovery compared to their respective controls.

5. journals.lww.com journals.lww.com/prsgo/fulltext/2024/04000/brief_intraoperative_electrical_stimulation_to.27.aspx

Brief Intraoperative Electrical Stimulation to Enhance Nerve ... Our data suggest that brief intraoperative electrical stimulation is safe and feasible. This study serves as pilot data for a current large ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2214751921000293

Application of electrical stimulation for peripheral nerve ... In this paper, we review the potential therapeutic benefits of electrical stimulation and the current limitations of regeneration after nerve injury.