Clinical trial NCT03996525: Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury
Official title: Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury - A Randomized Controlled Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemifacial Paralysis
Bell Palsy
Keywords: unilateral facial nerve palsy
facial nerve palsy
facial palsy
facial paralysis
cross facial nerve graft
CFNG
peripheral nerve stimulation
electrical stimulation
e-stim
free muscle transfer
FMT
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2019-06-24
Enrollment: 7
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Pre-Operative Lip Excursion with Smile
timeFrame: Change from Baseline (Pre-Op) over 2 Years
measure: Change in Myelinated Axon Count
timeFrame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
Secondary outcomes:
measure: Change in Facial Symmetry
timeFrame: Change from Baseline (Pre-Op) over 2 Years
measure: Facial Clinimetric Evaluation (FaCE) Scores
timeFrame: Change from Baseline (Pre-Op) Over 2 Years
measure: Time to Reinnervation
timeFrame: Up to 1 year after the Second Operation (FMT)
measure: Myelin Thickness
timeFrame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
measure: Nerve Fibre Diameter
timeFrame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
measure: Myelin Thickness/Fibre Diameter Ratio
timeFrame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Kristen Davidge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Ronald Zuker, MD
role: PRINCIPAL_INVESTIGATOR
References: