Plain English Summary
Background and study aims
Injuries causing nerve damage in the arm and hand are common. In severe cases, outcomes with surgery remain poor. Recently, in animal studies a short period of electrical stimulation applied to injured nerves was shown to improve nerve regeneration. Therefore, we plan to test this new method of treatment to determine whether it is also helpful in humans.
Who can participate?
We aim to recruit 150 adult patients of both genders over the age of 18 years who sustained severe injuries to nerves in the arm and hand.
What does the study involve?
Patients will be randomly allocated to either the control group with surgery alone or to the experimental group with additional electrical stimulation for an hour. Following the treatment, all measurements taken at the start of the study will be re-evaluated every three months for the first year and every six months during the second year. The timing and nature of the evaluation process will be identical in both groups.
What are the possible benefits and risks of participating?
If the additional treatment turns out to the effective, we anticipate that there will be greater functional improvements compared to conventional treatment alone. There are the possible risks of bleeding and infection from the needle electrode. To minimize those risks, the needle will be removed as soon as the stimulation is over.
Where is the study run from?
This single centre study will be run from the Peripheral Nerve Trauma Clinics at the University of Alberta (Canada).
When is the study starting and how long is it expected to run for?
The study started in August 2013 and will run until July 2017.
Who is funding the study?
The Canadian Institute of Health Research.
Who is the main contact?
Dr Ming Chanming
chan@ualberta.ca
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effectiveness of a new treatment for patients with peripheral nerve injuries in the upper limb
Acronym
Study hypothesis
1. Nerve regeneration in the arm and digital nerve in the hand can be significantly enhanced when they are combined with post-surgical electrical stimulation.
2. The improved nerve regeneration with post-operative electrical stimulation will result in a significant improvement in hand functions compared with surgery alone.
Ethics approval
Human Research Ethics Board (Biomedical), University of Alberta. Approval date: 8 March 2103. Reference Number: Pro00000973
Study design
Interventional randomised double-blind placebo-controlled single centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Peripheral nerve injury
Intervention
Intervention: Post surgical electrical stimulation
Controls: Surgery alone.
Duration: The electrical stimulation will last for 1 hour. Total follow up length is 2 years.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Motor unit number estimation - Nerve conduction studies to determine motor nerve regeneration.
2. Quantitative sensory testing to determine sensory nerve regeneration
All outcomes measured at baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Secondary outcome measures
1. Symptom severity scales - Questionnaires to determine change in symptom severity
2. Hand functional evaluation - Hand function tests to determine strength and dexterity
All outcomes measured at baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months
Overall trial start date
01/08/2013
Overall trial end date
30/07/2017
Reason abandoned
Eligibility
Participant inclusion criteria
Patients (both male and female over the age of 18 years) with severe injury to the nerves in the upper arm, forearm or hand causing denervation.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Other injuries that would impair hand function.
2. The presence of other neurologic conditions.
3. Cognitive compromise that renders the patients unable to understand and consent to the study.
4. Minors younger than the age of 18.
Recruitment start date
01/08/2013
Recruitment end date
30/07/2017
Locations
Countries of recruitment
Canada
Trial participating centre
5005 Katz Group Centre
Edmonton
T5R 2E1
Canada
Sponsor information
Organisation
University of Alberta (Canada)
Sponsor details
Research Ethics Office
308 Campus Tower
8625 112 Street
Edmonton
T6G 1K8
Canada
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Canadian Institute of Health (Canada) Reference number: RMF82496
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary