Testing Temporary Peripheral Nerve Stimulation against a placebo for nerve injury
Official title: Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation
- 2 groups
- Sites in Edmonton, Saint John and 4 more cities
- Recruiting
Interventions
- Medical device
Temporary Peripheral Nerve Stimulation System
Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.
- Medical device
Sham Temporary Peripheral Nerve Stimulation System
Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.
Canadian Sites (9)
7 of 9 recruiting
- Recruiting
Saint John Regional Hospital
Saint John, New Brunswick
- Recruiting
Hamilton General Hospital
Hamilton, Ontario
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
- Recruiting
Southlake Health
Newmarket, Ontario
- Recruiting
Humber River Health
Toronto, Ontario
- Recruiting
North York General Hospital
Toronto, Ontario
- Recruiting
Trillium Health Partners
Toronto, Ontario
- Completed
University of Alberta Hospital
Edmonton, Alberta
- Not currently recruiting
Roth | McFarlane Hand & Upper Limb Centre
London, Ontario
Eligibility Criteria
See who this study is looking for3 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Peripheral nerve injury
Exclusion
- −Peripheral neuropathy
- −Patients with any active implanted device
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Temporary Peripheral Nerve Stimulation System.
Registry label: A: Active treatment
Group B, the shamSham procedureA procedure made to feel like the real one, without the active step.Read more → group, receives Sham Temporary Peripheral Nerve Stimulation System.
Registry label: B: Sham treatment
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a sham procedureSham procedureA procedure made to feel like the real one, without the active step.Read more → — one made to feel like the real thing but without the active step.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 65 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 110 people.
The study is currently expected to finish around September 2026.
The main measurement is taken over: 6 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Sensory recovery — measured over 6 months.
Cumulative incidence of adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → — measured over 6 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05721261 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Temporary Peripheral Nerve Stimulation SystemDevice
Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Sham Temporary Peripheral Nerve Stimulation SystemDevice
Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study includes a shamSham procedureA procedure made to feel like the real one, without the active step.Read more → comparison — a procedure made to feel like the real one, without the active step.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 65 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 6 months.
The study as a whole is currently expected to finish around 2026-09.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 110 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Edmonton, Alberta, Canada; Saint John, New Brunswick, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada; Newmarket, Ontario, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.