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
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
Scientific
5005 Katz Group Centre
University of Alberta
Edmonton
T5R 2E1
Canada
Study information
| Study design | Interventional randomised double-blind placebo-controlled single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effectiveness of a new treatment for patients with peripheral nerve injuries in the upper limb |
| Study objectives | 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(s) | Human Research Ethics Board (Biomedical), University of Alberta. Approval date: 8 March 2103. Reference Number: Pro00000973 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2013 |
| Completion date | 30/07/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/08/2013 |
| Date of final enrolment | 30/07/2017 |
Locations
Countries of recruitment
- Canada
Study participating centre
T5R 2E1
Canada
Sponsor information
University/education
Research Ethics Office
308 Campus Tower
8625 112 Street
Edmonton
T6G 1K8
Canada
| Website | http://www.ualberta.ca/ |
|---|---|
"ROR" |
https://ror.org/0160cpw27 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
