NCT03205124

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

Completed Phase 2, PHASE3 Last updated 19 September 2024

What this trial tests

Phase 2, PHASE3 trial testing Electrical Stimulation in Peripheral Nerve Injuries in 38 participants. Completed in 13 October 2023.

Timeline

1 October 2017

Primary endpoint
13 October 2023

13 October 2023

Quick facts

Lead sponsor	University of Alberta
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	38
Start date	1 October 2017
Primary completion	13 October 2023
Estimated completion	13 October 2023
Sites	2 locations across Canada

Drugs / interventions tested

• Electrical Stimulation
• Sham Stimulation

Conditions studied

• Peripheral Nerve Injuries — all drugs for Peripheral Nerve Injuries →
• Sensory Deficit — all drugs for Sensory Deficit →
• Digital Nerve Lesion — all drugs for Digital Nerve Lesion →

Sponsor

University of Alberta

Who can join

Adults 18 to 65, any sex, with Peripheral Nerve Injuries or Sensory Deficit. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Modern Trends for Peripheral Nerve Repair and Regeneration: Beyond the Hollow Nerve Guidance Conduit.
   Carvalho CR, Oliveira JM, Reis RL. · · 2019 · cited 201× · PMID 31824934 · DOI 10.3389/fbioe.2019.00337
2. Recent perspectives on the synergy of mesenchymal stem cells with micro/nano strategies in peripheral nerve regeneration-a review.
   Sharifi M, Kamalabadi-Farahani M, Salehi M, Ebrahimi-Brough S, et al · · 2024 · cited 10× · PMID 39050683 · DOI 10.3389/fbioe.2024.1401512
3. Peripheral nerve repair: innovations and future directions.
   Aldali F, Tang L, Yang Y, Huang Y, et al · · 2026 · PMID 41634808 · DOI 10.1186/s12967-025-07567-z