H.P.J. Buschman

Effect and safety of spinal cord stimulation for treatment of chronic pain caused by diabetic neuropathy

AIM Spinal cord stimulation (SCS) has been shown effective as a therapy for different chronic painful conditions, but the effectiveness of this treatment for pain as a result of peripheral diabetic neuropathy is not well established. The primary objectives of this study were to evaluate the effect and safety of SCS for treatment of pain and the effects on microcirculatory blood flow in the affected areas in patients with refractory peripheral diabetic neuropathy. METHOD The study was designed as a prospective, open-label study. Data were collected during screening, at implant and at regular intervals, after initiation of therapy. Eleven diabetic patients with chronic pain in their lower limbs and no response to conventional treatment were studied. The SCS electrode was implanted in the thoracic epidural space. Neuropathic pain relief was assessed by Visual Analogue Scale (VAS) and microcirculatory skin perfusion was measured with Laser Doppler flowmetry. RESULTS Nine subjects had significant pain relief with the percutaneous electrical stimulator. Average pain score for all nine patients was 77 at baseline and 34 at 6 months after implantation. At the end of the study, eight of nine patients continued to experience significant pain relief and have been able to significantly reduce their pain medication. For six of them, the stimulator was the sole treatment for their neuropathic pain. No significant changes in microcirculatory perfusion were recorded. CONCLUSION Spinal cord stimulation offers an effective and safe therapy for chronic diabetic neuropathic pain.

Heart Rate Control Via Vagus Nerve Stimulation

Objectives.  There is ample and well‐established evidence that direct electrical stimulation of the vagus nerve can change heart rate in animals and humans. Since tachyarrhythmias cannot always be controlled through medication, we sought, in this pilot study, to elucidate whether a clinical implantable lead system that is used in cervical vagus nerve stimulation therapy (VNS therapy) also can be used for control of heart rate, and tachycardia in particular.

Vagus nerve stimulation for epilepsy activates the vocal folds maximally at therapeutic levels

PURPOSE Vagus nerve stimulation (VNS) for medically refractory epilepsy can give hoarseness due to stimulation of the recurrent laryngeal nerve. For a group of VNS-therapy users this side-effect interferes severely with their daily activities. Our goal was to investigate the severity of intra-operative VNS-related vocal fold contraction at different pulse widths and current output parameters. We investigated electromyographic and morphometric alterations on the vocal folds during VNS. METHODS Vocal fold EMG experiments were conducted intra-operatively during the implantation of a VNS system. During surgery the VNS pulse generator was programmed to stimulate at different pulse durations. At each pulse width the EMG-threshold current was determined by electrical stimulation of the vagus nerve with increasing stimulation currents. Laryngostroboscopic examination was performed after surgery to analyze the effects of spontaneous stimulation on the larynx. RESULTS The vocal fold EMG and morphodynamic changes in the larynx have been analyzed in eight patients. In all patients left vocal fold EMG-threshold was between 0.25 and 0.50 mA. Pulse duration had little influence on the EMG-threshold level. Vocal fold EMG saturation levels were reached between 0.75 and 1.00 mA. Video stroboscopic monitoring showed that stimulation induced an adductory spasm of either the ipsilateral vocal fold or the vestibular fold, and was present remarkably irrespective of the presence of hoarseness. CONCLUSIONS VNS causes pronounced effects on the vocal folds even at low stimulation amplitudes. At therapeutic levels even at the lowest stimulation pulse durations, the vocal fold contract, however, this does not necessarily give hoarseness.

An indirect component in the evoked compound action potential of the vagal nerve

The vagal nerve plays a vital role in the regulation of the cardiovascular system. It not only regulates the heart but also sends sensory information from the heart back to the brain. We hypothesize that the evoked vagal nerve compound action potential contains components that are indirect via the brain stem or coming via the neural network on the heart. In an experimental study of 15 pigs, we identified four components in the evoked compound action potentials. The fourth component was found to be an indirect component, which came from the periphery. The latency of the indirect component increased when heart rate and contractility were decreased by burst stimulation (P = 0.01; n = 7). When heart rate and contractility were increased by dobutamine administration, the latency of the indirect component decreased (P = 0.01; n = 9). This showed that the latency of the indirect component of the evoked compound action potentials may relate to the state of the cardiovascular system.

Application of a dual channel peroneal nerve stimulator in a patient with a "central" drop foot

Dropped foot is a common mobility problem amongst patients after a cerebro vascular accident. The condition arises from paresis of the muscles that control the foot movement during the swing phase of gait. If the abnormal movement is not compensated for, it results in a significant decrease in the mobility and hence quality of life. Compensation for the drop foot can be achieved through the application of functional electrical stimulation. To date, in the clinical environment, the stimulation has been applied through electrodes placed on the skin over the common peroneal nerve, and using a single channel implant device. It is well known that with these techniques it is difficult to establish a balanced response of the foot. An implantable dual channel system for stimulation of the deep and superficial peroneal nerve has now been developed for patients with a drop foot following a stroke. By stimulation of the two branches of the common peroneal nerve separately it is possible to achieve a precisely balanced dorsal flexion and eversion of the foot. Stimulation occurs via small bipolar electrodes which are placed subepineural. After successful tests on animals we have now started the two channel peroneal nerve stimulator implantation in patients. The preliminary results of the first implants are presented.

Electrode contact configuration and energy consumption in spinal cord stimulation.

OBJECTIVE To test the hypothesis that in spinal cord stimulation, an increase in the number of cathodes increases the energy per pulse, contrary to an increase in the number of anodes, which decreases energy consumption per pulse. METHODS Patients with an Itrel III (7425; Medtronic, Inc., Minneapolis, MN) implantable pulse generator and a Pisces-Quad (3487A; Medtronic, Inc.) implantable quadripolar lead were selected for this study. A set of 7 standard contact configurations was used for each patient. Resistor network models mimicking these configurations were constructed. The University of Twentes Spinal Cord Stimulation software was used to simulate the effect of these contact configurations on large spinal nerve fibers. To allow a comparison of the measured and modeled energy per pulse, all values were normalized. RESULTS Both the empirical and the modeling results showed an increase in energy consumption with an increasing number of cathodes. Although the patient data with 1 and 2 cathodes did not differ significantly, energy consumption was significantly higher when 3 cathodes were used instead of 1 or 2 cathodes. The average energy consumption was significantly higher when bipolar stimulation was used instead of monopolar cathodal stimulation. An increasing number of anodes caused a decrease in energy consumption. CONCLUSION When the paresthesia area can be covered with several configurations, it will be beneficial for the patient to program a configuration with 1 cathode and either no or multiple anodes.

Contact configuration and energy consumption in spinal cord stimulation

Objective To test the hypothesis that, in contrast to an increase of the number of anodes which reduces energy consumption per pulse, an increase of the number of cathodes raises the energy consumption.