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出境医 / 临床实验 / Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury

Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury

Study Description
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.


Condition or disease Intervention/treatment Phase
Hemifacial Paralysis Bell Palsy Device: Electrical Stimulation Device: Sham Treatment Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury - A Randomized Controlled Prospective Study
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : September 15, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Electrical Stimulation

Electrical Stimulation

The patient will receive active electrical stimulation.

 Device: Electrical Stimulation

Two-Stage Facial Reanimation (Standard Practice) with electrical stimulation for one hour at 20Hz (Experimental Procedure).

  1. Cross-Facial Nerve Graft (CFNG) immediately followed by electrical nerve stimulation proximal to the coaptation site on the donor facial nerve.
  2. Nine-to-Twelve Months later, Free Muscle Transfer (FMT) followed by electrical nerve stimulation proximal to the coaptation site in the intraoral incision.
Placebo Comparator: Sham Treatment

No Electrical Stimulation

The patient will receive sham electrical stimulation.

 Device: Sham Treatment

Two-Stage Facial Reanimation (Standard Practice) with sham electrical stimulation for one hour (Placebo).

  1. Cross-Facial Nerve Graft (CFNG) followed by placement of unelectrified electrodes proximal to the coaptation site on the donor facial nerve.
  2. Free Muscle Transfer (FMT) followed by placement of unelectrified electrodes proximal to the coaptation site in the intraoral incision.
Outcome Measures
Primary Outcome Measures :
  1. Change in Pre-Operative Lip Excursion with Smile [ Time Frame: Change from Baseline (Pre-Op) over 2 Years ]
    FACEGRAM will be used to objectively analyse change in commissure excursion.

  2. Change in Myelinated Axon Count [ Time Frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later ]
    The number of myelinated nerve fibres that regenerate and reach the distal CFNG will be compared between groups.


Secondary Outcome Measures :
  1. Change in Facial Symmetry [ Time Frame: Change from Baseline (Pre-Op) over 2 Years ]
    FACEGRAM will be used to objectively analyse smile symmetry.

  2. Facial Clinimetric Evaluation (FaCE) Scores [ Time Frame: Change from Baseline (Pre-Op) Over 2 Years ]

    The Facial Clinimetric Evaluation (FaCE) Scale is a patient-report questionnaire assessing facial impairment and disability associated with facial paralysis. The 15-item likert scale questionnaire consists of six domains: i) facial movement, ii) facial comfort, iii) oral function, iv) eye comfort, v) lacrimal control and vi) social function.

    Each domain produces its own score, with 1 meaning 'problems all the time' and 5 suggesting 'no problems at all.' The domain scores can then be summed to produce a total score assessing total quality of life with respect to facial paralysis.


  3. Time to Reinnervation [ Time Frame: Up to 1 year after the Second Operation (FMT) ]
    Study participants are requested to monitor their facial movements and record any changes in a daily diary once they first notice facial movement.

  4. Myelin Thickness [ Time Frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later ]
    Using histomorphometry, Myelin Thickness will be used as a surrogate measure for the rate of axon regeneration.

  5. Nerve Fibre Diameter [ Time Frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later ]
    Using histomorphometry, Nerve Fibre Diameter will be used as a surrogate measure for the rate of axon regeneration.

  6. Myelin Thickness/Fibre Diameter Ratio [ Time Frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later ]
    Using histomorphometry, Myelin Thickness/Fibre Diameter Ratio will be used as a surrogate measure for the rate of axon regeneration.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Kariym Joachim, MSc 416-813-7654 ext 228840 kariym.joachim@sickkids.ca

Locations
Layout table for location information
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Kariym Joachim, MSc         
Sponsors and Collaborators
The Hospital for Sick Children
The Physicians' Services Incorporated Foundation
Investigators
Layout table for investigator information
Principal Investigator: Gregory Borschel, MD The Hospital for Sick Children
Principal Investigator: Ronald Zuker, MD The Hospital for Sick Children
Tracking Information
First Submitted Date  ICMJE June 20, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE September 16, 2019
Estimated Primary Completion Date March 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Change in Pre-Operative Lip Excursion with Smile [ Time Frame: Change from Baseline (Pre-Op) over 2 Years ]
    FACEGRAM will be used to objectively analyse change in commissure excursion.
  • Change in Myelinated Axon Count [ Time Frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later ]
    The number of myelinated nerve fibres that regenerate and reach the distal CFNG will be compared between groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Change in Facial Symmetry [ Time Frame: Change from Baseline (Pre-Op) over 2 Years ]
    FACEGRAM will be used to objectively analyse smile symmetry.
  • Facial Clinimetric Evaluation (FaCE) Scores [ Time Frame: Change from Baseline (Pre-Op) Over 2 Years ]
    The Facial Clinimetric Evaluation (FaCE) Scale is a patient-report questionnaire assessing facial impairment and disability associated with facial paralysis. The 15-item likert scale questionnaire consists of six domains: i) facial movement, ii) facial comfort, iii) oral function, iv) eye comfort, v) lacrimal control and vi) social function. Each domain produces its own score, with 1 meaning 'problems all the time' and 5 suggesting 'no problems at all.' The domain scores can then be summed to produce a total score assessing total quality of life with respect to facial paralysis.
  • Time to Reinnervation [ Time Frame: Up to 1 year after the Second Operation (FMT) ]
    Study participants are requested to monitor their facial movements and record any changes in a daily diary once they first notice facial movement.
  • Myelin Thickness [ Time Frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later ]
    Using histomorphometry, Myelin Thickness will be used as a surrogate measure for the rate of axon regeneration.
  • Nerve Fibre Diameter [ Time Frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later ]
    Using histomorphometry, Nerve Fibre Diameter will be used as a surrogate measure for the rate of axon regeneration.
  • Myelin Thickness/Fibre Diameter Ratio [ Time Frame: Change from Baseline (Pre-Op) to the Final Surgery 1 Year Later ]
    Using histomorphometry, Myelin Thickness/Fibre Diameter Ratio will be used as a surrogate measure for the rate of axon regeneration.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury
Official Title  ICMJE Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury - A Randomized Controlled Prospective Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hemifacial Paralysis
  • Bell Palsy
Intervention  ICMJE
  • Device: Electrical Stimulation

    Two-Stage Facial Reanimation (Standard Practice) with electrical stimulation for one hour at 20Hz (Experimental Procedure).

    1. Cross-Facial Nerve Graft (CFNG) immediately followed by electrical nerve stimulation proximal to the coaptation site on the donor facial nerve.
    2. Nine-to-Twelve Months later, Free Muscle Transfer (FMT) followed by electrical nerve stimulation proximal to the coaptation site in the intraoral incision.
  • Device: Sham Treatment

    Two-Stage Facial Reanimation (Standard Practice) with sham electrical stimulation for one hour (Placebo).

    1. Cross-Facial Nerve Graft (CFNG) followed by placement of unelectrified electrodes proximal to the coaptation site on the donor facial nerve.
    2. Free Muscle Transfer (FMT) followed by placement of unelectrified electrodes proximal to the coaptation site in the intraoral incision.
Study Arms  ICMJE
  • Experimental: Electrical Stimulation

    Electrical Stimulation

    The patient will receive active electrical stimulation.

    Intervention: Device: Electrical Stimulation
  • Placebo Comparator: Sham Treatment

    No Electrical Stimulation

    The patient will receive sham electrical stimulation.

    Intervention: Device: Sham Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 21, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2022
Estimated Primary Completion Date March 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kariym Joachim, MSc 416-813-7654 ext 228840 kariym.joachim@sickkids.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03996525
Other Study ID Numbers  ICMJE 1000063546
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gregory Borschel, MD, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE The Physicians' Services Incorporated Foundation
Investigators  ICMJE
Principal Investigator: Gregory Borschel, MD The Hospital for Sick Children
Principal Investigator: Ronald Zuker, MD The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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