Recruitment by motor nerve root stimulators: significance for implant design.

Three paraplegics have been implanted with stimulators of the lumbar anterior roots. Twelve roots were trapped in slots, each with three electrodes, a central cathode and two anodes, but the anodes in all the slots were connected together to reduce the number of wires. Cross-talk between roots was observed at lower levels than expected. Cross-talk was assessed from the ratio of the root's threshold to the threshold of the contralateral response (expected ratio: 72). Two hypothetical reasons for this low ratio were: that the cathode current was not equally shared by the anodes; or that the contralateral responses were reflex. Experiments showed that neither explanation was valid. The ratio of the contralateral to ipsilateral threshold for individual slots (K(1)) was sometimes low because the ipsilateral threshold was high. By taking the ratio of the lowest contralateral response to lowest ipsilateral response, for all roots in each subject (K(2)), the ratio should approach the theoretical value. However, for the two subjects with small slots, it was 7.9 and 15.3, much less than 72, suggesting that the original theory was incorrect. Approximate calculations of the activation function suggest that the reason may be that roots which run close to a slot, but not through it, may pass through a virtual anode region outside the ends of the slots, and that anodal break stimulation in those regions causes the cross-talk. Our estimate is that this cross-talk would be expected to occur at intensities above 5.3 times the cathodal threshold. If the roots are stimulated in pairs, below the levels of cross-talk, experimental results show that the moments obtained in response are additive to within 5%.

Functional electrical stimulation and rehabilitation--an hypothesis.

Functional Electrical Stimulation (FES), used to mimic a weak or paralysed movement, sometimes is followed by a specific recovery of voluntary power in that movement. The mechanism by which this occurs is unclear, and the presumption has often been that FES may somehow promote adaptive changes in cortical connectivity. However, the unique feature of electrical stimulation is that it activates nerve fibres both orthodromically and antidromically. The antidromic impulse in motor nerve fibres will reach the anterior horn cell, but it can go no further up the neuraxis. If the corticospinal-anterior horn cell synapse is a Hebb-type modifiable synapse (i.e. one that is strengthened by the coincidence of presynaptic and postsynaptic activity), then FES, combined with coincident voluntary effort through a damaged pyramidal motor system, could help to promote restorative synaptic modifications at anterior horn cell level, by this unique adaptive mechanism.

A reconnectable multiway implantable connector.

A well-tried plug-and-socket connector system designed for connecting multichannel implanted cables was adapted so as to allow disconnection and reconnection during surgery. Five different sealing techniques were tested in vitro, and it was found that only one of them had the required qualities of high leakage path impedance (taken as more than one megaohm for the worst sample) after three months of saline soak, together with demountability under surgical conditions. The system has subsequently been successfully implemented in a patient in whom reconnection was required two years after implantation.

Technical note. Estimated electrode operating conditions of the first London Mk V implanted stimulator.

The electrodes of an implanted stimulator must be operated in such a way that the task of converting an electron current in metal to an ion current in tissue is achieved without release of noxious chemical species into the tissue, and without significant corrosion of the electrode metal. Both these effects depend on the charge density at which the electrodes are operated. In bringing a newly designed multichannel stimulator into service, the charge densities can only be known when the operating stimulus strengths have been determined. Even then, unless the stimulator is arranged to telemeter out what it is doing, any charge-density figures obtained have the character of estimates, rather than measurements. The first London Mk. V stimulator is used to enable a paraplegic woman to stand up. This note provides estimates of the average charge density and corrosion rate for the Pt--Ir electrodes used. These fall within limits which we believe to be generally accepted as safe.

Selecting candidates for a lower limb stimulator implant programme: a patient-centred method.

OBJECTIVE: To develop an effective selection procedure for lower limb functional neurostimulation (LLFNS) for standing in paraplegia. DESIGN: The selection procedure and exclusion criteria were based on the previous experience for two clinical centres with experience of LLFNS. SETTING: Two Regional Spinal Injuries units in southern England. SUBJECTS: 254 fully rehabilitated paraplegics living in the community. INTERVENTION: Patients were invited to participate in the programme, and if suitable to subject themselves to a rigorous staged selection procedure from which they could withdraw at any time. OUTCOME MEASURE: Functionally successful home standing using closed-loop surface electrical stimulation. RESULTS: 57/254 patients were suitable on paper and were accessible. 19 of these (CI = 10-28) were interested in the project and attended one of the spinal centres for details. Twelve (CI = 5-19) of these fulfilled the selection criteria and started on the training programme; and 10 of them completed the muscle training programme successfully. Seven patients (CI = 2-12) achieved closed-loop standing in the laboratory and four patients (CI = 1-8) did so at home.

Functional electrical stimulation.

In the health-care professions, electrical stimulation is used for three purposes: to aid diagnosis; as a therapeutic tool; and to restore lost or damaged functions. Functional electrical stimulation (FES) and functional neurostimulation (FNS) are terms which are more or less interchangeable, and which encompass the third of these purposes. FES itself can also be conveniently divided into three classes, according to purpose: the restoration of sensor functions; the restoration of skeleto-motor functions; and the restoration of autonomic functions. Potentially, a fourth class would comprise devices restoring cognitive or psychological functions, but no such devices are clinically available as yet. The methods and devices which are currently available for providing FES are reviewed, as are the sorts of result and benefit that may be expected from them. The structure and emphasis of the review is on the clinical applications and the relevant anatomical and neurophysiological considerations and this approach is chosen for two main reasons. Firstly, the clinical, anatomical, and physiological considerations are independent of technological change and development, so they will not become quickly out of date. Secondly, the author is a clinician by profession, and an engineer only by inclination. The functional aims of FES methods will continue to develop as a result of experience gained following the introduction and use of successful devices, and these evolutionary improvements will come from within the FES programme; but the engineering embodiment of those devices may be revolutionized at any time by technological advances coming from elsewhere.

Lumbar root stimulation for restoring leg function: results in paraplegia.

We have implanted an intradural array of 12 tripolar electrodes on the anterior roots L2-S2, left and right, at cauda equina level, in a 33-year-old woman with a complete T9 cord lesion of 3 years' duration. They are driven by an implanted multiplexed stimulator system using radio frequency (RF) power and control signals. All channels generate movements, in patterns that might be predicted from the known anatomy of the cauda equina. In particular, stimulation of L2 and L3 gives hip adduction; L3, L4, and L5 gives quadriceps femoris movements; L5, S1, and S2 gives hamstrings movement; and S1 and S2 give plantar flexion. Stimulation of L5 gives mixed movements at the ankle. Surprisingly, stimulation of the L2 roots has not given strong hip flexion. Responses have been stable. Some thresholds have varied, probably as a result of tissue encapsulation. The moment generated within each degree of freedom of the legs has been measured for each root, using a specially designed multimoment measurement apparatus. For several roots, a movement of lower threshold may be accompanied by a second movement of higher electrical threshold, suggesting that different muscles may have fiber populations that differ in their diameter or their location in the root. The use of stimulus forms that enable selective anodal block may, in the future, enable separation of two distinct movements from a single motor root.

Implant provision of key, pinch and power grips in a C6 tetraplegic.

An 11-channel multiplexed stimulator of nerves and muscles in the left forearm was implanted for hand control in January 1986 in a 21 year old woman who, after sustaining a C6 spinal lesion 7 years earlier, had voluntary shoulder and elbow movement but paralysed hands, trunk and legs. The patient controls the stimulation via a microcomputer control box and an RF transdermal link. We have investigated the control of her stimulated hand with a joystick under her contralateral hand which she moves from the shoulder and elbow. Since 1986, we have tried a variety of joystick control schemes involving power and key grips. Currently, for grip adjustment, forward and backward joystick movements correspond to thumb extension and abduction, respectively giving in addition both finger and wrist extension, whereas right and left joystick movements yield fist closure and thumb opposition/adduction and flexion, respectively. Useful grasps are available by moving the joystick forward and then left (key grip), by moving the joystick backward and left (pinch grip), or by moving the joystick back and right (power grip). Thus, three distinct grips may be selected using these three quadrants of joystick movement. An additional control mode was found to be desirable to augment the patient's limited voluntary wrist positioning and provide wrist stability while adjusting finger grip.

Long-term follow-up of patients with sacral anterior root stimulator implants.

The first 50 patients to receive a sacral anterior root stimulator for bladder control were reviewed by questionnaire in mid-1989. At that time, the follow-up period varied from 5 to 11 years, and 48 of the group were alive; 2 had died from unrelated causes. Forty-one used their implants regularly for micturition and of these, 37 were always or usually continent. Twenty-nine reported no symptomatic urinary infections in the previous year, and only 4 had 3 infections or more. Twenty-seven used their implant to assist defaecation, and 13 of 32 male users reported full implant-driven erections. Side effects are minor, except for stimulus evoked pain sensation, which prevents use of the implant in 3 of the 7 non-users. Two of the other non-users were awaiting repair of their implant faults.

Postural sway during retinal image stabilisation.

Posturographic measurements using a piezoelectric platform were made in normal subjects while wearing a combination of spectacle and contact lens providing partial stabilisation of the retinal image (RIS). The amount of postural sway seen while wearing the device at rest is intermediate between the "normal vision" and "eyes closed" conditions, and increases with increasing amounts of RIS. However, when large active head-and-eye movements are performed, postural sway is dramatically increased when using RIS, and is then worse than while performing the same task in the "eyes closed" condition. It is concluded that patients who use the partial-RIS device for the treatment of severe oscillopsia may benefit only when performing tasks in which the head is relatively still, such as reading, writing or watching TV. It is also proposed that the partial-RIS device can serve as a model in normal free-standing subjects for the postural effects of oculomotor disorders.

Implant infections and antibiotic-impregnated silicone rubber coating.

A method is described for coating silicone rubber-encapsulated implant devices with an outer layer of silicone rubber impregnated with a mixture of gentamicin sulphate and diethanolamine fusidate. A coating of this sort provides bactericidal activity lasting for a few days in the film of fluid surrounding such an implant. When used for coating our implants, the retrospective rate of implant infections believed to have been introduced at the time of surgery was reduced to 0.7% (coated), compared with 10.0% (uncoated), a highly significant difference (p less than 0.001). Systemic perioperative antibiotic prophylaxis was not shown to confer any such benefit.

Effects of retinal image stabilization in acquired nystagmus due to neurologic disease.

We studied the effects of variable amounts of artificial retinal image stabilization (RIS) upon oscillopsia and visual acuity in eight patients with acquired nystagmus due to neurologic disease. We measured horizontal and vertical eye movements with the magnetic search coil technique and used these electronic signals to control the position of a visual stimulus on a screen in front of the patient. We also used an optical device to stabilize images of the real world upon the retina. During electronic stabilization, RIS was progressively increased until oscillopsia was abolished; this was achieved in all eight patients and corresponded to retinal image drift of 5 degrees/sec or less. In five patients with downbeat nystagmus, further increases in RIS caused the oscillopsia to reappear, but in the opposite direction. Electronic stabilization also improved visual acuity in four of five patients; the limitation of improvement could be related to coexistent visual system defects. Using electronic feedback, we could measure the range of RIS that any individual required to abolish oscillopsia; from this measurement, the components of the optical device that were best suited to provide a stable field of vision could be calculated.

A putative non-cholinergic mechanism in urinary bladders of New but not Old World primates.

The effects of atropine on bladder contractions evoked by sacral ventral root stimulation were investigated in two species of New World monkey (marmoset and cebus) and in paraplegic man. The findings were then compared to those previously obtained for the cat and two species of Old World monkey (rhesus and baboon). The results show the marmoset and cebus to represent a transitional stage between the complete sensitivity of the bladders of Old World monkeys to atropine and the relative insensitivity of the cat bladder. The bladder response is shown to comprise two components, an atropine sensitive component which is slow in onset and an atropine resistant component which is easily fatigued. The experiments in paraplegic people confirm that the parasympathetic innervation of the bladder of man is, like that of Old World monkeys, exclusively cholinergic. A behavioural interpretation is tentatively offered to explain the two types of innervation.

Sacral anterior root stimulators for bladder control in paraplegia: the first 50 cases.

The first 50 patients who have received sacral anterior root stimulator implants are presented, with follow-up of from 1 to 9 years. Forty-nine are alive and 43 are regularly using their implants for micturition. Of the 49 living, 39 are "very pleased, without significant reservations", six are pleased on balance but have reservations, and four are dissatisfied. Residual urine volumes are substantially reduced in all patients who are using their implants. Ten of the 12 female patients and the majority of male patients have become continent. The voiding pressure in implant-driven micturition can be regulated by adjusting the stimulus parameters, and is always kept below 90 cm H2O. Of seven patients with ureteric reflux before operation, four have ceased to reflux and the other three are unchanged. Changes in the radiographic appearances of the bladder have been favourable or zero, but there have been two cases of deterioration in the upper urinary tracts. Significant harmful effects have been CSF leaks, urinary infections following post-operative urodynamic study, and accidental damage to roots. Anterior roots nearly always recover from accidental damage, and posterior roots do not.

Urodynamic observations on patients with sacral anterior root stimulators.

The urodynamic changes produced by sacral anterior root stimulators have been assessed in 13 patients with spinal injuries. Before surgery all of the eleven men and two women had poor or absent bladder control with large residual volumes. Videocysto-urethrography with pressure and flow studies was performed pre-operatively and repeated once post-operatively, at intervals of 6 months to 5 years. In all cases the residual volume was reduced to less than 50 ml and the functional bladder capacity increased to within the normal range. All the patients were able to void voluntarily by activating their implants in bursts. This produced an interrupted stream at normal voiding pressures and acceptable flow rates. There was definite improvement in vesico-ureteric reflux and decrease in bladder trabeculation following implantation of the stimulator. Use of the stimulator has enabled nine of the patients to be continent at night. Eight of them are also dry during the day.

Gating of somatosensory evoked potentials during different kinds of movement in man.

1. Somatosensory evoked potentials from electrical stimulation of the digital nerves of the right thumb have been recorded during the performance of various motor tasks in eight normal subjects. 2. The N20-P30 primary cortical response is only moderately affected by task context, while the P45-N55 secondary response is markedly 'gated' by movement of the stimulated digit. The late N140 vertex is variable. 3. In most subjects, active and passive movements are about equally effective in suppressing the secondary complex; but in one, passive movement has come to be rather less effective than active. 4. Secondary response suppression occurs in proportion to the velocity of the movement of the thumb, up to a velocity of 20 deg/s. 5. Secondary response suppression is unrelated to load in the range 0 to 0.16 Nm. 6. When the stimulus is timed to occur at various points in movement, secondary complex suppression occurs at all stages; but there is little or no suppression when stimulation is timed at 200 ms before the start of or 500 ms after the end of a movement. 7. Secondary response suppression is maximal when the same digit is both moving and shocked. When the right index or little finger are moved instead, the right thumb being stimulated, suppression is less; when the left thumb moves, no suppression is seen. 8. Secondary response suppression is reduced but not lost if the skin and interphalangeal joint of the thumb are anaesthetized distal to the stimulating electrodes. 9. Secondary response suppression is unimpaired when the radial nerve is anaesthetized, paralysing the finger extensors. 10. In an attempt to identify the course taken by the afferent volley between the primary and secondary responses, and to identify the gating site, we recorded the responses in six patients with Parkinson's disease who had undergone thalamotomy. Their secondary responses were present, and gated in the normal way. 11. We are unable to confirm whether the secondary response represents the re-arrival at cortical level of a volley that has traversed the cerebrocerebellar loop. 12. We confirm that the secondary complex is located a little anterior to the primary cerebral response. 13. We conclude that a gating action is exerted in the brain on somatosensory afferent activity, after it first reaches the cortex, and that this gating action associated with movement is controlled by other afferent signals from the stimulated limb, and particularly from the stimulated digit.