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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ preop, every 3 to 6 months for 2 years

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

888 Previous Clinical Trials

384,878 Total Patients Enrolled

Ming Chan, MB ChBPrincipal InvestigatorUniversity of Alberta

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for the clinical trial still open to participants?

"Affirmative. According to clinicaltrials.gov, the medical trial originally posted on March 1st 2013 is currently recruiting patients and was last updated on July 29th 2022. Eighty individuals must be recruited from one site for this study to move forward."

Answered by AI

What is the current size of enrollment for this experiment?

"Correct. According to information on clinicaltrials.gov, this trial is currently in the process of recruitment and was initially posted on March 1st 2013. The study requires 80 participants from one medical centre for full enrollment."

Answered by AI