Electrical stimulation has been shown to enhance nerve regeneration and muscle reinnervation in animals and to have some efficacy in patients with spinal cord injury. Currently there is no method in clinical use to speed the rate of recovery after peripheral nerve injury, and electrical stimulation has not been previously studied for peripheral nerve injuries in humans. The objective of this study is to explore the ability of electrical stimulation to benefit the treatment of patients with brachial plexus injury. Our hypothesis is that treatment with electrical stimulation after autogenous peripheral nerve reconstruction will accelerate nerve regeneration, reduce the period of denervation and improve muscle reinnervation and recovery, and quality of life in patients with brachial plexus injury.
The specific aim i s to conduct a double-blind placebo-controlled pilot clinical trial of the safety and efficacy of electrical stimulation in improving success following reconstructive surgery in patient with brachial plexus injuries of the upper extremity. This application represents the first translational study proposed to investigate the use of electrical stimulation as a treatment option for the management of peripheral nerve injury. Such an agent could improve outcomes and significantly reduce long-term disability related to nerve injuries. A faster recovery would also mean sooner return to work, or simply return to work where it might otherwise not be possible, with potentially significant reduction in expenditures related to work days lost or job loss. Collectively these factors could significantly reduce the huge societal and financial burden of these patients, as well as the overwhelming and life-changing psychoemotional and financial stress experienced by these patients. The PI and his team have extensive experience in the management of severe peripheral nerve injuries, especially those involving the brachial plexus, and have also contributed significantly to the basic science literature in the study of the enhancement of nerve regeneration. Members of this group are also authorities in the evaluation of upper extremity impairment and the conduct of clinical trials. Therefore they are uniquely qualified to perform the study proposed, investigate further modifications of therapy and patient population as appropriate, and ultimately deliver efficient translation of information between the laboratory and clinical settings.
This application represents the first translational study proposed to investigate the use of electrical stimulation to benefit the treatment of patients with brachial plexus injury by accelerating nerve regeneration, reducing the period of denervation, and improving muscle reinnervation and functional recovery. Potential benefits include improved outcomes, less long-term disability related to nerve injuries, and reduction in the huge societal and financial burden of these patients, as well as the overwhelming and life-changing psychoemotional and financial stress experienced by these patients. If proven to be beneficial, its use could be recommended for practically any peripheral nerve injury including those managed non-surgically.