Condition category
Injury, Occupational Diseases, Poisoning
Date applied
12/08/2013
Date assigned
04/09/2013
Last edited
04/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Ming Chan

ORCID ID

Contact details

5005 Katz Group Centre
University of Alberta
Edmonton
T5R 2E1
Canada

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

http://www.ualberta.ca/

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

Publication citations

Additional files

Editorial Notes