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Electrical Stimulation for Peripheral Nerve Injury

Phase 2 & 3
Recruiting
Led By K Ming Chan, MB ChB
Research Sponsored by Ming Chan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-65
With a traumatic complete transection of one or more digital nerve(s) in the hand
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1,2,3,4,5,6 months
Awards & highlights

Study Summary

This trial will test whether electrical stimulation can help nerves regenerate after being cut. There will be 3 groups- one that gets pre and post-operative stimulation, one that just gets pre-operative, and a control group.

Who is the study for?
This trial is for individuals aged 18-65 who have a complete cut of one or more digital nerves in the hand and can receive surgery within two weeks of injury. It's not suitable for those under 18 or over 65, with uncontrolled diabetes, cognitive issues, non-English speakers, unfit for general anesthesia, partial nerve lacerations, crush injuries, bone injuries in the same finger as the nerve damage, large gaps in nerves requiring grafts or extreme bending to repair.Check my eligibility
What is being tested?
The study tests if pre-operative electrical stimulation helps heal sensory and motor fibers after a digital nerve is completely cut. Participants will be randomly assigned to either get this stimulation before and after surgery (two groups), or a sham (fake) treatment that mimics the procedure without actual stimulation.See study design
What are the potential side effects?
While specific side effects are not detailed here since it's an experimental procedure based on animal studies; potential risks may include discomfort at the site of electrical stimulation and possible skin irritation from electrode placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have a completely severed nerve in my hand due to an injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1,2,3,4,5,6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1,2,3,4,5,6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensory nerve conduction studies
Secondary outcome measures
CASE (Computer assisted Sensory Examination)
Cold temperature detection threshold
DASH questionnaire
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Pre-operative stimulationExperimental Treatment1 Intervention
Patients randomized to this group will receive 1 hour of continuous electrical stimulation three days prior to scheduled surgical date. The frequency will be fixed at 20Hz and the voltage and duration of electrical pulses will be sequentially increased to the maximum tolerable limit. As the nerve becomes accustomed to the sensation of the stimulation, the voltage is increased to the next tolerable threshold and this is repeated throughout the one-hour period. Once the stimulation is complete, the stimulator is detached and the patient is informed of the surgical date. The wires are taken out at the conclusion of the pre-operative appointment. These patients will have fine gauge wires for post-operative sham stimulation implanted at the time of surgery. In the post-operative recovery room the stimulator is attached to their wires. However, the voltage will only be increased to a level they are able to sense.
Group II: Pre and Post-operative stimulationExperimental Treatment1 Intervention
Patients randomized to this group will receive 1 hour of continuous electrical stimulation three days prior to scheduled surgical date and then again immediately post operatively. The frequency will be fixed at 20Hz and the voltage and duration of electrical pulses will be sequentially increased to the maximum tolerable limit. As the nerve becomes accustomed to the sensation of the stimulation, the voltage is increased to the next tolerable threshold and this is repeated throughout the one-hour period. Patients randomized to this group will also receive 1 hour of continuous electrical stimulation post-operatively. These patients will have fine gauge wires for post-operative stimulation implanted at the time of surgery. In the post-operative recovery room the stimulator is attached to their wires. The frequency will be fixed at 20Hz and the voltage and duration of electrical pulses will be sequentially increased to the maximum tolerable limit for one hour.
Group III: Sham stimulationPlacebo Group1 Intervention
These patients will have the stimulator attached to their wires 3 days prior to scheduled surgical date and postoperatively as were in the previous groups. However, the voltage will only be increased to a level they are able to sense. The stimulator was then be turned off without the patients' knowledge. All connections are left in place for anhour duration. These patients will similarly have their wires removed after the conclusion of their pre-operative appointment and at the first post-operative follow-up within 1 week of surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electrical Stimulation
2013
Completed Phase 2
~410

Find a Location

Who is running the clinical trial?

Ming ChanLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
University of AlbertaLead Sponsor
884 Previous Clinical Trials
392,994 Total Patients Enrolled
K Ming Chan, MB ChBPrincipal InvestigatorUniversity of Alberta

Media Library

Electrical Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT03205124 — Phase 2 & 3
Peripheral Nerve Injury Research Study Groups: Pre-operative stimulation, Pre and Post-operative stimulation, Sham stimulation
Peripheral Nerve Injury Clinical Trial 2023: Electrical Stimulation Highlights & Side Effects. Trial Name: NCT03205124 — Phase 2 & 3
Electrical Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03205124 — Phase 2 & 3
Peripheral Nerve Injury Patient Testimony for trial: Trial Name: NCT03205124 — Phase 2 & 3

Frequently Asked Questions

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

How can I become a participant in this research?

"This study requires that participants have suffered from a peripheral nerve injury, and be of ages 18-65. They are still in need of 66 individuals to fill the clinical trial."

Answered by AI

Are there any patients required for this experiment?

"That is correct. The information available on clinicaltrials.gov suggests that this trial is still searching for patients. This study was first posted on October 1st, 2017 and was most recently edited on May 27th, 2022. 66 individuals are needed to participate across 2 different sites."

Answered by AI

Does this research allow for participants aged 35 years and older?

"The age range for this particular study is between 18-65, with 3 other studies catering to a younger demographic and 13 for seniors."

Answered by AI

How many people are currently enrolled in this clinical trial?

"Yes, according to the information available on clinicaltrials.gov, this study is currently enrolling participants. The trial was first posted on October 1st, 2017 and was last updated on May 27th, 2022. 66 individuals are needed for the trial across 2 locations."

Answered by AI

Who else is applying?

What state do they live in?
Alberta
What site did they apply to?
University of Alberta Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
3+

Why did patients apply to this trial?

I have Arachnoiditis in my back which has affected nerves at L4-L5 and S1. Medication is not an option due to my current job position.
PatientReceived 1 prior treatment
Recent research and studies
~4 spots leftby Aug 2024