What side effects are associated with this type of intervention?

Electrical stimulation (ES) is a treatment being studied for its potential to promote peripheral nerve regeneration. Known side effects of ES can include skin irritation or burns at the site of electrode placement, muscle soreness, and discomfort during the stimulation process. In some cases, improper use of ES can lead to nerve damage or exacerbate existing injuries. Other treatments for peripheral nerve injury, such as surgical repair, may carry risks of infection, scarring, and incomplete nerve recovery. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved various treatments for peripheral nerve injuries, including electrical stimulation devices. Electrical stimulation has been shown to promote peripheral nerve regeneration by improving functional recovery and increasing myelinated axon counts distal to the repair site. This method has demonstrated efficacy comparable to systemic administration of FK506 in animal studies. While specific FDA-approved devices for electrical stimulation in humans were not detailed, the general approval of such devices indicates their recognized potential in enhancing nerve repair and regeneration.

What other types of research exist?

Promising novel alternatives to electrical stimulation for peripheral nerve injury include: 1) Platelet-Rich Plasma (PRP) injections, which contain growth factors that may promote tissue repair and nerve regeneration. 2) Stem cell therapy, particularly the use of mesenchymal stem cells, which have shown potential in enhancing nerve repair and functional recovery. 3) Gene therapy, which involves delivering specific genes to promote nerve growth and repair. 4) Biomaterial scaffolds, which provide structural support and can be combined with growth factors or cells to enhance nerve regeneration.

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Electrical Stimulation for Peripheral Nerve Injury

Phase 2 & 3

Waitlist Available

Led By K Ming Chan, MB ChB

Research Sponsored by Ming Chan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18-65

With a traumatic complete transection of one or more digital nerve(s) in the hand

Must not have

Large nerve gap requiring graft, conduit or extreme joint flexion

Age <18y and >65y

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1,2,3,4,5,6 months

Summary

This trial is testing whether using electrical currents to stimulate nerves can help young people with severe hand nerve injuries heal better. The electrical stimulation helps the nerves grow back by activating certain healing processes in the body. Electrical stimulation has been shown to promote nerve regeneration and functional recovery in various studies.

Who is the study for?

This trial is for individuals aged 18-65 who have a complete cut of one or more digital nerves in the hand and can receive surgery within two weeks of injury. It's not suitable for those under 18 or over 65, with uncontrolled diabetes, cognitive issues, non-English speakers, unfit for general anesthesia, partial nerve lacerations, crush injuries, bone injuries in the same finger as the nerve damage, large gaps in nerves requiring grafts or extreme bending to repair.

What is being tested?

The study tests if pre-operative electrical stimulation helps heal sensory and motor fibers after a digital nerve is completely cut. Participants will be randomly assigned to either get this stimulation before and after surgery (two groups), or a sham (fake) treatment that mimics the procedure without actual stimulation.

What are the potential side effects?

While specific side effects are not detailed here since it's an experimental procedure based on animal studies; potential risks may include discomfort at the site of electrical stimulation and possible skin irritation from electrode placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have a completely severed nerve in my hand due to an injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need surgery for a large nerve gap in my body.

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I am younger than 18 or older than 65.

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My diabetes is not under control (HbA1C>8%).

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I do not speak English.

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I cannot or choose not to undergo general anesthesia.

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I have been diagnosed with cognitive impairment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1,2,3,4,5,6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1,2,3,4,5,6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1,2,3,4,5,6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sensory nerve conduction studies

Secondary study objectives

CASE (Computer assisted Sensory Examination)

DASH questionnaire

Semmes-Weinstein Monofilaments

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Pre-operative stimulationExperimental Treatment1 Intervention

Patients randomized to this group will receive 1 hour of continuous electrical stimulation three days prior to scheduled surgical date. The frequency will be fixed at 20Hz and the voltage and duration of electrical pulses will be sequentially increased to the maximum tolerable limit. As the nerve becomes accustomed to the sensation of the stimulation, the voltage is increased to the next tolerable threshold and this is repeated throughout the one-hour period. Once the stimulation is complete, the stimulator is detached and the patient is informed of the surgical date. The wires are taken out at the conclusion of the pre-operative appointment. These patients will have fine gauge wires for post-operative sham stimulation implanted at the time of surgery. In the post-operative recovery room the stimulator is attached to their wires. However, the voltage will only be increased to a level they are able to sense.

Group II: Pre and Post-operative stimulationExperimental Treatment1 Intervention

Patients randomized to this group will receive 1 hour of continuous electrical stimulation three days prior to scheduled surgical date and then again immediately post operatively. The frequency will be fixed at 20Hz and the voltage and duration of electrical pulses will be sequentially increased to the maximum tolerable limit. As the nerve becomes accustomed to the sensation of the stimulation, the voltage is increased to the next tolerable threshold and this is repeated throughout the one-hour period. Patients randomized to this group will also receive 1 hour of continuous electrical stimulation post-operatively. These patients will have fine gauge wires for post-operative stimulation implanted at the time of surgery. In the post-operative recovery room the stimulator is attached to their wires. The frequency will be fixed at 20Hz and the voltage and duration of electrical pulses will be sequentially increased to the maximum tolerable limit for one hour.

Group III: Sham stimulationPlacebo Group1 Intervention

These patients will have the stimulator attached to their wires 3 days prior to scheduled surgical date and postoperatively as were in the previous groups. However, the voltage will only be increased to a level they are able to sense. The stimulator was then be turned off without the patients' knowledge. All connections are left in place for anhour duration. These patients will similarly have their wires removed after the conclusion of their pre-operative appointment and at the first post-operative follow-up within 1 week of surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Electrical Stimulation

2013

Completed Phase 3

~450

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral nerve injuries can result from various types of trauma, leading to significant functional impairments. Treatments aim to promote nerve regeneration and restore function. Electrical stimulation (ES) is one such treatment, which has shown promise in animal studies for enhancing both sensory and motor nerve regeneration. ES works by applying electrical currents to the injured nerves, which can accelerate axonal growth and improve reinnervation of target muscles. This is crucial for patients as it can potentially reduce the time for functional recovery and improve overall outcomes. Other treatments include surgical repair and physical therapy, which also aim to support nerve healing and functional restoration.