RU2204423C2 - Method for treating patients for chronic spinal cord injuries - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: method involves carrying out electric stimulation locomotor movements result invoked in easy position assumed by patient in lying dorsal position or in lateral position with legs suspended on Balkan frames. The patients are doing the procedure themselves, using a chronic stimulation system implanted on permanent base. The system has a pair of wire electrodes set at the Th12-L1 vertebra level connected to an immersed stimulator part being receiver built-in into the anterior abdominal wall and external transmitter bound to the receiver via inductive link. Pulsating currents of rectangular shape of 0.5-1 ms duration, 0.1-7 mA amplitude with individually selected frequency in 2-100 Hz bandwidth are applied as stimulation treatment to enable walking manner of movements invoked by electric stimulation therapy. EFFECT: enhanced effectiveness of treatment.

Description

 The invention relates to medicine, namely to neurology, neurosurgery and rehabilitation, and can be used in the treatment of patients with chronic spinal cord injury of a non-inflammatory nature.

 The development of implantation technologies has led to the creation of subcutaneous implantable stimulants, including the domestic implantable electrostimulator of deep brain structures Neuroelectron IEGSM PB4.000, designed for chronic electrical stimulation of various areas of the spinal cord and brain. The implantation of a stimulator on an ongoing basis or for a long period of time allows the patient, after selecting stimulation regimens, to carry out therapeutic procedures independently at home. However, to date, chronic epidural electrostimulation has been used only for antispastic and antalgic purposes [1, 2].

 A method has been developed for treating patients with the consequences of spinal cord injury [3], which consists in epidural and then cutaneous electrical stimulation of the lumbar thickening of the spinal cord with the effect of triggering coordinated “walking” movements of both legs. The disadvantages of stimulation through transdermally removed electrodes are the danger of infection, the need for constant monitoring of the condition of the skin and the long stay of the patient in the hospital.

 The objective of the proposed method is the restoration of motor functions of the lower extremities or compensation of forced physical inactivity in patients with chronic damage to the spinal cord caused by a disease or damage to the spine.

 The solution to the problem is achieved by daily procedures of electrical stimulation of the locomotor zone of the lumbar thickening of the spinal cord, carried out by the patient independently or with the help of relatives, with a motor effect in the form of coordinated "walking" leg movements. Electrical stimulation is carried out through a pair of wire electrodes permanently implanted in the posterior epidural space to the level of the lumbar thickening of the spinal cord and connected by a connector to the immersion part of the stimulator (receiver), implanted subcutaneously on the anterior abdominal wall. The connection between the submersible and the cutaneous parts of the stimulator Neuroelectric IEGSM PB4.000 is carried out inductively. To induce locomotor activity, the parameters of electrical stimulation are selected individually in a frequency range of 2-100 Hz with an amplitude of 0.1-7 mA, a duration of 0.5-1 ms, rectangular current pulses, with the patient on the back or side with half-curved suspended on the Balkan frames legs.

 The method allows paralyzed patients to independently invoke coordinated walking movements of the legs to compensate for forced physical inactivity and restore the ability to walk. The effect is achieved through the activation and training of spinal locomotor generators.

 The method is as follows.

 The method of setting the stimulator. Under sterile conditions, under local anesthesia from separate punctures at the level of the interosseous space L2-3, two electrodes are punctured epidurally through a Thouhy needle so that their working ends are located obviously above the level of the lumbar enlargement. Under x-ray control, determine the zone of standing of the electrodes, determine their distance from the proposed "locomotor zone" (level of the vertebral bodies T12-L1), after which the electrodes are pulled by the calculated value. Through a temporary connector, the electrodes are connected to an external stimulator and test stimulation is performed. The correct standing of the electrodes is confirmed by the presence of evoked responses of the flexor muscles and extensors of the thigh and lower leg during stimulation with a frequency of 2 Hz. Then, in the frequency range of 2-100 Hz, with stimulus amplitude from 0.1 to 7 mA with a stimulus duration of 0.5-1 ms, stimulation parameters are selected that are effective for invoking coordinated "walking" leg movements. The criteria for a coordinated motor response are the opposite direction of movements in the joints of the same name on the right and left legs or movements in more than two joints of one leg. A trocar type conductor through micro incisions forms a subcutaneous canal along the lateral surface of the abdominal wall into which electrodes connected to a permanent connector are immersed. An implantable stimulator is attached to the latter, immersed in a previously prepared pocket in the subcutaneous fatty tissue of the anterior surface of the abdomen. Skin wounds in the incision area (above the electrodes, connector, stimulator) are sutured tightly.

 Stimulation procedure. The ESSM procedure is performed when the patient is lying on his back with his legs bent on two Balkan frames. The patient activates the stimulator and adjusts the pre-selected stimulation parameters independently or with the help of relatives. The "step" of the legs begins simultaneously with the start of electrical stimulation or 8-10 minutes after its start. The recommended duration of the procedures is from 40 to 180 minutes per day, depending on the age and condition of the patient, with mandatory monitoring of tolerance of loads according to heart rate and blood pressure.

 The motor effect in the form of "walking" leg movements is achieved by activating the spinal locomotor generators located in the lumbar thickening of the spinal cord. Regular procedures prevent the development of dystrophic processes in the spinal cord and leg muscles and have a training effect. Electrostimulation effects on the spinal cord and the intense motor activity caused by them can help restore the connections between the spinal cord and brain lost as a result of a disease or injury, up to the restoration of independent walking.

 The proposed method can be used in the treatment of myelopathy caused by tuberculosis and nonspecific spondylitis, malformations, deformations or instability of the spine, combined trauma of the spine and spinal cord. It is especially recommended in severe cases requiring prolonged electrical stimulation exceeding the time of rehabilitation treatment of the patient in the hospital, as well as for chronically paralyzed patients in order to prevent dystrophic changes in the spinal cord and muscles and compensate for forced physical inactivity.

 Example. Patient P.A. at the age of 11, he was operated on for fibrous dysplasia of the vertebral bodies Th 2-4, complicated by compression of the spinal cord and a picture of lower spastic paraplegia - a posterior decompression laminectomy was performed with partial resection of the pathological vertebral bodies. After the operation, a complete regression of neurological disorders was noted, however, during the year there was a sharp increase in kyphotic deformation, accompanied by a re-development of paraplegia. At the age of 13 years, in the conditions of a specialized vertebrological clinic, he was repeatedly operated - anterior spine reconstruction with anterior osteoplastic fixation was performed. Additionally, posterior instrumental fixation of the spine by two contractors and posterior osteoplastic fixation were performed, as a result of which anterior decompression of the spinal cord was achieved, a significant reduction in kyphotic deformation and stability of the spine were ensured, but no changes in neurological status occurred.

 First entered our clinic at the age of 14 with a diagnosis of the consequences of fibrous dysplasia of Th2-Th4 vertebrae. Condition after repeated surgical interventions (resection of the vertebrae and removal of the extradural component of the tumor) with fixation of the spine by two contractors. Lower spastic paraplegia (type A according to Frankel). Pelvic dysfunction by type of incontinence. The duration of paraplegia at the time of admission is 2 years. On examination by a neurologist, a clinic for transverse lesions of the spinal cord from level D3. During a neurophysiological examination: with magnetic pulse transcranial stimulation - lack of response of the muscles of the lower extremities; lack of somatosensory evoked potentials for stimulation of n.tibialis. The H-reflex on both sides is preserved, the amplitude is increased, the lack of response to audio irritation and reception of Endrasik. The data are regarded as evidence of a functionally complete lesion of the conduction pathways of the spinal cord while the motor nuclei of the lumbar thickening are intact.

 Comprehensive rehabilitation therapy has begun, including epidural spinal cord stimulation with a puncture electrode installation at the L1 level, therapeutic exercises and drug vasodilator therapy. When conducting stimulation procedures in the mode of continuous rhythmic stimulation with frequencies of 3-10 Hz and 30-60 Hz, alternate walking movements of the legs were obtained, later a similar motor effect was obtained with cutaneous ESSM. The duration of the course of rehabilitation measures is 5 months, including epidural electrical stimulation 3 months. Repeated rehabilitation therapy courses (a total of 5, including 3 courses of epidural stimulation and 2 - cutaneous) lasting 2-3 months were conducted annually. Slow positive dynamics in neurological and rehabilitation status was observed after each course. To date, the ability to hold urine for a long time, independent portioned urination, and regular independent defecation have been formed. Decrease in the level of surface sensitivity disorders by 6 segments, in the legs - mosaic slightly differentiated sensitivity, restoration of deep sensitivity along the hip joints inclusively. The muscle tone in the muscles of the legs at rest is slightly reduced, in the morning and when the body position changes, it is increased with high clonic activity. No bedsores and muscle atrophy. Neurological testing of movements or muscle tension of the legs was not detected, at the same time, the patient confidently moves on all fours and knees with additional support. After the ESSM procedure, the patient stands with additional support on the walker, is able to walk for a short time with additional support. A neurophysiological study revealed the restoration of supra- and propriospinal effects on the motor nuclei of the lumbar thickening without restoration of the cortico-spinal tract. Based on myographic recordings of tetrapedal and vertical walking, the patient is regarded as Frankel type C, despite the clinically persistent paraplegia.

 In order to conduct chronic epidural electrical stimulation of the lumbar thickening of the spinal cord, the Neuroelect system was set up with predefined individual stimulation parameters (frequency 3-12 Hz, amplitude 3-5 mA, stimulus duration 0.5 ms). Alternate movements of both legs, reminiscent of jogging, with movements in the hip, knee and metatarsophalangeal joints with a frequency of about 3 Hz began after 8-10 minutes of stimulation and continued until its end. The duration of the ESSM procedure was about 40 minutes. During the stimulation, pronounced autonomic reactions were observed: facial flushing, profuse sweating, increased pulse rate and blood pressure (heart rate from 60 to 90-110 / sec, blood pressure from 115/70 to 125/80) with recovery within 5-8 minutes the end of the procedure. The patient regarded the condition after stimulation as moderate fatigue after exercise.

 During the ES, the patient could not stand or walk even with vertical support in the parachute system, however, immediately after the ES he was able to stand and walk (75-100 m) for a limited time with additional support on the walker, without fixing the knee joints After the course of treatment in the clinic, similar procedures are continued at home.

 The stimulation set included single-channel electrodes of a wire type with cylindrical end working surfaces, temporary and permanent connectors, implantable and external stimulators, a trocar-type conductor and a pulling device (Neuroelect IEGSM PB4.000, developed by NIIFOI).

Sources of information
1. Modern aspects of electrical neurostimulation and new technologies in neurosurgery and neurology // Collection of scientific papers. - Saratov. - 1998 .-- 192 p.

 2. Spinal Cord Stimulation: an innovative method in the treatment / Ed. S. Horsch, L. Claeys, Darmstadt. - 1994 .-- p.198.

 3. RF patent 2130326, A 61 N 1/18, 1/32, 1/36. A method for the treatment of patients with spinal cord lesions. / Shapkov Yu.T., Shapkova E.Yu., Mushkin A.Yu. // Bull. 14 from 05.20.1999.

Claims (1)

 A method of treating patients with chronic spinal cord lesions, including epidural electrical stimulation of the lumbar spinal cord thickening with the effect of coordinated locomotor movements caused by a relaxed position of a patient lying on his back or side with legs suspended on Balkan frames, characterized in that the patients carry out the procedures on their own with using a permanent implanted system for chronic stimulation, including a pair of wire electrodes installed at the level of Th12- L1 vertebrae connected to the immersion part of the stimulator by a receiver implanted on the anterior abdominal wall, and an externally located transmitter that is inductively coupled to the receiver, and the stimulation is performed by rectangular current pulses of 0.5-1 ms duration, 0.1-7 mA amplitude , with an individually selected frequency in the range of 2-100 Hz, providing a coordinated "walking" character caused by electrical stimulation of leg movements.