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Electrical Stimulation for Nerve Injury Recovery

N/A
Recruiting
Led By Ming Chan, MB ChB
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with severe injury to the brachial plexus causing complete denervation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preop, every 3 to 6 months for 2 years
Awards & highlights

Study Summary

This trial is testing whether electrical stimulation can help improve hand function in people who have had surgery for nerve damage in the arm.

Who is the study for?
This trial is for adults with severe brachial plexus injuries, which have led to complete loss of nerve function in the arm. Participants must be able to understand and consent to the study's procedures. It excludes minors, individuals with cognitive impairments that affect their understanding of the study, or those with other neurological conditions.Check my eligibility
What is being tested?
The trial is examining if post-surgical electrical stimulation can improve hand function and nerve regeneration after an arm nerve injury repair surgery. Patients will be randomly assigned to either receive this treatment or be in a control group, with follow-up evaluations over two years.See study design
What are the potential side effects?
While specific side effects are not detailed here, electrical stimulation may cause discomfort at the site of application, muscle twitching during application, and skin irritation beneath electrodes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a severe arm nerve injury with total loss of movement or feeling.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preop, every 3 to 6 months for 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and preop, every 3 to 6 months for 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the sensory nerve action potential amplitude (uV) at 2 years .
Secondary outcome measures
Change in the ability to perform hand function at 2 years.
Change in the compound muscle action potential amplitude (mV) at 2 years
Change in the motor unit number estimation at 2 years

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Post surgical electrical stimulationActive Control1 Intervention
Balanced AC pulse at 20 Hz with less than 30V and 0.01 ms duration will be delivered for 1 hour.
Group II: Sham stimulationPlacebo Group1 Intervention
Stimulation with the same parameters delivered only for 5 s.

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Who is running the clinical trial?

University of AlbertaLead Sponsor
900 Previous Clinical Trials
387,580 Total Patients Enrolled
Ming Chan, MB ChBPrincipal InvestigatorUniversity of Alberta
~3 spots leftby Dec 2024
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