Clinical Trial: Electrical Stimulation to Enhance Peripheral Nerve Regeneration
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Effectiveness of a New Treatment for Patients With Peripheral Nerve Injuries in the Upper Limb
Brief Summary: The primary goal of this study is to quantify the functional deficits caused by injuries to the brachial plexus and peripheral nerve in the arm. The second goal is to test the possible benefit of electrical stimulation of the injured nerve following surgery. The investigators will test whether electrical stimulation will improve hand function and nerve regeneration after repair for nerve injury. Injuries causing nerve damage in the arm and hand are common. In severe cases, functional outcomes even with surgery remain poor. Recently, electrical stimulation has been applied to injured nerves in rats. This was shown to improve nerve regeneration. These studies showed that as little as one hour of electrical stimulation was effective. Therefore, the investigators plan to test this new method of treatment to determine whether it is also helpful in humans. These will be done by using a symptom severity questionnaire, nerve conduction studies and by testing pressure sensations, hand dexterity and strength. The patients will be randomized to either the treatment or control group. Following the treatment, all baseline measurements will be reevaluated every three months for the first year and every 6 months during the second year. The timing and nature of the evaluation process will be identical in both groups.
Detailed Summary:
Background Rationale:
Surgical repair and nerve grafting are currently the standard treatment for nerve laceration. However, even with that, the functional outcome in patients with proximal nerve cut is often poor. In those cases, the surviving axons in the proximal nerve stump have already reached their capacity limit to sprout and to reinnervate. Therefore, no further reinnervation can occur even with surgery unless regeneration and extension of the proximal stump can somehow be enhanced. Unfortunately, although many attempts, none were shown to be effective in the clinical setting.
Post-surgical electrical stimulation:
Recent studies demonstrated that electrical stimulation applied directly to an injured peripheral nerve resulted in marked improvement of nerve regeneration. Preliminary data suggesting that electrical nerve stimulation could possibly enhance nerve regeneration has in fact been known for some time. Accelerated rate of regeneration was found in animals that received electrical stimulation for as little as 1 hour. Furthermore, preferential growth of the regenerating sensory axons into the appropriate nerve branch was also accelerated with electrical stimulation.
Since these studies showed that as little as one hour of electrical stimulation was effective in accelerating nerve regeneration, it opens the possibility of applying this to humans. The intervention is safe and of minimal discomfort. Furthermore, the use of electrical stimulation as a clinical treatment modality is already well accepted. In a recent study, the investigators applied this to patients with severe median nerve compressive injury in the carpal tunnel following surgery. The procedure was well tolerated with no adverse event observed in any
Sponsor: University of Alberta
Current Primary Outcome: Change in the sensory nerve action potential amplitude (uV) at 2 years . [ Time Frame: preop, every 3 to 6 months for 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in the compound muscle action potential amplitude (mV) at 2 years [ Time Frame: preop, every 3 to 6 months for 2 years ]
- Change in the motor unit number estimation at 2 years [ Time Frame: preop, every 3 to 6 months for 2 years ]
- Change in the ability to perform hand function at 2 years. [ Time Frame: preop, every 3 to 6 months for 2 years ]
Original Secondary Outcome: Same as current
Information By: University of Alberta
Dates:
Date Received: March 16, 2015
Date Started: March 2013
Date Completion: March 2017
Last Updated: March 31, 2016
Last Verified: March 2016
