Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury

The Hospital for Sick Children

Status

Terminated

Conditions

Hemifacial Paralysis

Bell Palsy

Treatments

Device: Electrical Stimulation

Device: Sham Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03996525

1000063546

Details and patient eligibility

About

After nerve injury and facial palsy, many patients have permanent muscle and sensory dysfunction. Electrical stimulation (ES) of injured nerves may speed up axon growth and improve recovery. This study will assess if ES accelerates motor axon regeneration and improves muscle recovery in patients undergoing two-staged facial reanimation for facial palsy.

This study of ES in these patients will investigate:

i) nerve regeneration over long distances;

ii) direct evidence of changes in nerve regeneration with nerve samples from the second procedure; and

iii) changes in functional outcomes in a patient population with much less variability.

Our study will provide evidence about the effect of ES in improving outcomes in patients with nerve injuries.

Enrollment

7 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients undergoing unilateral facial reanimation with a two-stage cross-face nerve graft and free gracilis muscle flap transfer who have;

i) isolated unilateral facial nerve palsy and
ii) a functioning contralateral facial nerve.

Exclusion criteria

Any disorders that may compromise nerve regeneration or muscle function following muscle transfer, including diabetes, polyneuropathy, or myopathy and muscular dystrophy.
Patients with severe cognitive impairment, which would limit their participation