The Effect of Pre-operative Electrical Stimulation on Peripheral Nerve Regeneration.

Summary

Traumatic injury to the peripheral nerves is most common in the young population with high associated costs to the patient, as well as to society. These range from acute healthcare cost to loss of productivity and rehabilitation. Despite major efforts in improving surgical technique, functional outcome has not significantly improved in the past thirty years. Irreversible denervation, atrophy of target muscles, and deranged sensation secondary to slow or aberrant axonal outgrowth remains a significant challenge. Although pre-operative conditioning of the injured peripheral nerve with electrical stimulation has shown promise in animal studies, it has not been tested in humans.

In animal studies, pre-operative conditioning with electrical stimulation (ES) of the injured peripheral nerves promoted peripheral nerve regeneration in both sensory and motor fibres. We propose to conduct a clinical trial comparing 3 different treatments of complete digital nerve laceration before and after surgical repair. Participants will be randomized to one of three treatment arms: i) pre and post operative electrical stimulation, ii) pre-operative electrical stimulation alone , or iii) control group that receives sham pre and post-operative electrical stimulation. We will evaluate the effect of pre-operative electrical stimulation on axonal regeneration, as well as determine whether there is an additive effect of pre and post-operative electrical stimulation on sensory nerve axonal regeneration.

Conditions

• Peripheral Nerve Injuries
• Sensory Deficit
• Digital Nerve Lesion

Interventions

PROCEDURE

Electrical Stimulation

The experimental treatment involves implantation of 2 sterilized fine-gauge Teflon coated wires percutaneously. The ends of the wire are stripped for conductivity. Electrical stimulation is given at a fixed continuous frequency of 20Hz. The stimulus intensity is the maximum tolerable limit. The wires are then taped to the skin with surgical wound tape at a location away from the wound for strain relief. To ensure sterility, care is taken to dress the sutured wound and hand, as well apply the splint. The wires are removed either immediately at the conclusion of the pre-operative appointment and immediately after surgery or at the first surgical follow-up with dressing change, within one week of surgery.

PROCEDURE

Sham Stimulation

The experimental treatment involves implantation of 2 sterilized fine-gauge Teflon coated wires percutaneously. The ends of the wire are stripped for conductivity. Electrical stimulation is begun until the patient senses the stimulation, then the stimulation is discontinued.The wires are then taped to the skin with surgical wound tape at a location away from the wound for strain relief. To ensure sterility, care is taken to dress the sutured wound and hand, as well apply the splint. The wires are removed either immediately at the conclusion of the pre-operative appointment and immediately after surgery or at the first surgical follow-up with dressing change, within one week of surgery.

Sponsors & Collaborators

• University of Alberta

  lead OTHER

Principal Investigators

• K Ming Chan, MB ChB · University of Alberta

• Julie Beveridge, MD · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-01

Primary Completion

2023-10-13

Completion

2023-10-13

Countries

• Canada

Study Locations