The LION procedure to the pelvic nerves in the treatment of children with spina bifida
Spina bifida is a birth defect that occurs when a baby's backbone (spine) does not develop normally. As a result, the spinal cord and the nerves that branch out from it may be damaged. Depending on the severity of the defect and where it is on the spine, symptoms can vary. Mild defects may cause few or no problems, while more severe defects can cause serious problems, including weakness, loss of bladder control (urinary catheterization may be needed), or paralysis. Children with an exposed opening on the back will require surgery to close it. After recovery from surgery, babies born with a meningocele or myelomeningocele may need long-term care to help treat any underlying conditions that result from their spina bifida. Those with paralysis may eventually need walking aids like leg braces, walkers, or a wheelchair. Children with myelomeningocele who also have hydrocephalus will need the continuing care of a neurosurgeon, and they may have learning difficulties in school that require special educational services.
Electrical stimulation of the pelvic nerves (so-called sacral nerve stimulation) is one promising therapeutic modality in children with spina bifida but only very few cases have been reported in the literature 41. Despite the fact that percutaneous implantation, coming from behind through the sacrum, is minimally invasive and non-destructive, anatomic abnormalities and scar tissue can make implantation difficult whereas partial or complete destruction of the sacral nerve roots can compromise the effectiveness of sacral nerve stimulation (SNS). In a prospective randomized controlled study to evaluate the possible benefits of electrical stimulation, Guys reported on some improvements concerning bladder compliance and the functional bladder capacity but not for bladder voiding and incontinence 42 . In contrast to the classical dorsal approach, the LION procedure presents decisive advantages:
  • It permits the bypassing of anatomic abnormalities due to the lesion but also possible difficulties for implantation due to scar tissue secondary to previous dorsal surgeries for closure of the opening on the back. By laparoscopy, the implantation is done ventrally to the sacral bone in absolutely normal anatomic conditions, where no previous surgeries have taken place.
  • The technique of intraoperative electro stimulation of the nerves – the technique is also known as the LANN technique (Laparoscopic Neuro-Navigation) 43– enables the surgeon to establish intra-operatively an exact functional cartography of all the pelvic nerves, that in combination with preoperative findings, enable him to place the electrode in a more suitably adapted way to the individual neural situation of each patient.
The present technique of laparoscopic implantation of neuroprothesis might be a revolutionary therapeutic approach for children with spina bifida for improving pelvic organ functions, recovery of locomotion and at least some quality of life. Because spina bifida in fact causes an “incomplete spinal cord injury”, stimulation of the pelvic nerves might, as in our research, induce in post-accident people with SCI changes in the nervous system that might induce nerve growth and the reconnection necessary for the development of voluntary nerve functions. Long term follows-up and a bigger study are needed to better evaluate the efficacy of this technique, but the main restrictive factor is the size of the pacemaker. Pacemakers are currently implanted under the skin of the anterior abdominal wall, while lead electrodes connect it to the nerves. Such neuroprothesis are as yet not adapted for stimulation in children and the further development of such micrositumlators implanted in close proximity to the nerves is required, not least because children will undergo further growth; meaning increased tension on the cable, risk for migration of the lead electrodes is elevated, as well as particular circumstances arising in the case of a pregnancy.

“In-body-FES” in people with spinal cord injuries
Spinal cord injury affects approximately 800, 000 people worldwide, with 25, 000 new cases every year. Spinal cord injury (SCI) dramatically changes the life of the affected person. The loss of control of skeletal muscles, sensations below the injury, together with serious disturbances in autonomic nervous system functions, produce a profound deterioration in the quality of life and loss of autonomy. In view of trends in the epidemiology of SCI, it is becoming increasingly important to develop treatment strategies that can enhance recovery motor function, walking in particular, following SCI. The goal of Functional Electrical Stimulation - FES - is to obtain an immediate contraction of the skeletal muscles that will lead to functional movement. Even though FES-assisted walking has been available for more than three decades, it has not been widely used in rehabilitation because the stimulators were bulky, unreliable, prone to breakage and expensive.
Laparoscopy is actually the only minimally invasive technique that enables placement of stimulator electrodes to the pelvic nerves for FES of the pelvic nerves involved in leg function. Nerve stimulation has major advantages compared to electrical muscle stimulation to induce harmonious movements with less fatigue effect. Because electrodes are connected to a rechargeable pacemaker, continuous stimulation of the nerves over the long-term is feasible. Both passive (low current continuous stimulation) and active FES (FES-assisted-training) induces significant building of muscle mass that constitutes a major preventative effect in the formation of decubitus lesions and the destabilization of articulations. Stimulation of the pelvic nerves also increases the cutaneous temperature in stimulated areas – especially in the gluteal region. This effect is probably due to pelvic sympathetic nerves neuromodulation that increases oxygen pressures cutaneous and enhanced angiogenesis. This effect, in combination with standing/walking training (discharge of the bottom) and the above-mentioned stimulation-induced building of gluteal muscle mass (“gluteal pads effect”), serve to better protect patients from decubitus, deep venous thrombosis and edema.
Previous experimental studies have indicated that electrical stimulation can lead to significant functional recovery due to alternate synaptic pathways, axonal regeneration and reconnection.
Over the last 10 years, we transferred this knowledge to clinical applications and were able to report on unexpected findings in 18 spinal cord injured people who underwent a LION procedure for functional electrical stimulation (FES)-assisted locomotor training and continuous low-frequency electrical stimulation. Twelve patients are currently capable of weight bearing standing and stepping with crutches by simultaneous electrical stimulation (the best in the study for 2.6 km), and six of them are capable of walking several meters (the best in the study for 400m) without electrical stimulation. Our findings suggest that FES-assisted locomotor training in combination with continuous low-frequency pelvic nerve stimulation in spinal cord injury patients may induce changes that affect the central pattern generator and allow supra and infra-spinal inputs to engage residual spinal or extra spinal pathways for reconnection 10-11.

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  • Introduction

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  • In-body-Functional Electrical Stimulation

    There is a long history for the therapeutic use of electrical stimulation. More than 30 years ago Functional Electrical Stimulation (FES) was developed as an orthotic system to be used for SCI patients.

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  • ISoN Projects

    • Development of a micro stimulator easely implantable to nerves by endoscopic approach, without need for cable-extension, and small enough to be implanted also in children (spina bifida)
    • Clinical studies in spina bifida children and SCI people

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  • Literature Footnotes

    In-body-Functional Electrical Stimulation - Literature Footnotes

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