Electrical stimulation after nerve repair to enhance regeneration

ISRCTN ISRCTN52307835
DOI https://doi.org/10.1186/ISRCTN52307835
Secondary identifying numbers N/A
Submission date
12/08/2013
Registration date
04/09/2013
Last edited
04/09/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Ming Chan
Scientific

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

Study information

Study designInterventional randomised double-blind placebo-controlled single centre study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effectiveness of a new treatment for patients with peripheral nerve injuries in the upper limb
Study objectives1. 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(s)Human Research Ethics Board (Biomedical), University of Alberta. Approval date: 8 March 2103. Reference Number: Pro00000973
Health condition(s) or problem(s) studiedPeripheral nerve injury
InterventionIntervention: Post surgical electrical stimulation
Controls: Surgery alone.
Duration: The electrical stimulation will last for 1 hour. Total follow up length is 2 years.
Intervention typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/08/2013
Completion date30/07/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants150
Key inclusion criteriaPatients (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.
Key exclusion criteria1. 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.
Date of first enrolment01/08/2013
Date of final enrolment30/07/2017

Locations

Countries of recruitment

  • Canada

Study participating centre

5005 Katz Group Centre
Edmonton
T5R 2E1
Canada

Sponsor information

University of Alberta (Canada)
University/education

Research Ethics Office
308 Campus Tower
8625 – 112 Street
Edmonton
T6G 1K8
Canada

Website http://www.ualberta.ca/
ROR logo "ROR" https://ror.org/0160cpw27

Funders

Funder type

Government

Canadian Institute of Health (Canada) Reference number: RMF82496

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan