Safety and efficacy of occipital nerve stimulation for attack prevention in medically intractable chronic cluster headache (ICON): a randomised, double-blind, multicentre, phase 3, electrical dose-controlled trial.

Background: Occipital nerve stimulation (ONS) has shown promising results in small uncontrolled trials in patients with medically intractable chronic cluster headache (MICCH). We aimed to establish whether ONS could serve as an effective treatment for patients with MICCH.

Methods: The ONS in MICCH (ICON) study is an investigator-initiated, international, multicentre, randomised, double-blind, phase 3, electrical dose-controlled clinical trial.

Occipital nerve stimulation in medically intractable, chronic cluster headache. The ICON study: rationale and protocol of a randomised trial.

Background: About 10% of cluster headache patients have the chronic form. At least 10% of this chronic group is intractable to or cannot tolerate medical treatment. Open pilot studies suggest that occipital nerve stimulation (ONS) might offer effective prevention in these patients.

Effect of spinal cord stimulation in Type I complex regional pain syndrome with 2 rare severe cutaneous manifestations.

The authors present the case of a 49-year-old female patient with complex regional pain syndrome-Type I (CRPSI) who was suffering from nonhealing wounds and giant bullae, which dramatically improved after spinal cord stimulation (SCS). The scientific literature concerning severe cutaneous manifestations of CRPS-I and their treatment is reviewed. Nonhealing wounds and bullae are rare manifestations of CRPS-I that are extremely difficult to treat.

Upregulation of the GABA-transporter GAT-1 in the spinal cord contributes to pain behaviour in experimental neuropathy.

Sciatic nerve ligation in rats (chronic constriction injury (CCI)) induces signs and symptoms that mimic human conditions of neuropathy. The central mechanisms that have been implicated in the pathogenesis of neuropathic pain include increased neuronal excitability, possibly a consequence of decreased availability of spinal GABA. GABA availability is regulated by the presence of the GABA-transporters (GATs).

Efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a randomised controlled trial.

Background: Intractable spasticity can be treated effectively with continuous infusion of intrathecal baclofen. Because evidence for its use in the treatment of children with spastic cerebral palsy is lacking, we conducted a randomised controlled trial.

Aims: To test whether continuous infusion of intrathecal baclofen is effective in comparison with standard treatment only.

Safety and one-year efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy.

Background: Prospective studies that address both efficacy and safety of continuous infusion of intrathecal baclofen (CITB) in children with spastic cerebral palsy (CP), and that use outcome measures beyond muscle tone are lacking.

Aims: To study the efficacy at 12 months and safety up to 24 months after start of CITB in children with intractable spastic CP.

Methods: Nine girls and eight boys, aged 13.

The restore rechargeable, implantable neurostimulator: handling and clinical results of a multicenter study.

Background: Spinal cord stimulation is an effective therapy for chronic, neuropathic pain refractory to medication. Use of a rechargeable neurostimulation system (Restore, Medtronic Inc) could provide greater longevity in the treatment of complex pain. However, patients' ability to successfully recharge a neurostimulation system has not yet been demonstrated.

Intrathecal baclofen in children with spastic cerebral palsy: a double-blind, randomized, placebo-controlled, dose-finding study.

Intrathecal baclofen (ITB) therapy can be very effective in the treatment of intractable spasticity, but its effectiveness and safety have not yet been thoroughly studied in children with cerebral palsy (CP). The aims of this double-blind, randomized, placebo-controlled, dose-finding study were to select children eligible for continuous ITB infusion, to assess the effective ITB bolus dose, and to evaluate the effects, side effects, and complications. Outcome measures included the original Ashworth scale and the Visual Analogue Scale for individually formulated problems.

Differential effects of subthalamic nucleus stimulation in advanced Parkinson disease on reaction time performance.

The aim of the present study was to assess the effect of bilateral subthalamic nucleus (STN) stimulation and dopaminergic medication on speed of mental processing and motor function. Thirty-nine patients suffering from advanced Parkinson disease (PD) were operated on. Motor function and reaction time (RT) performance [simple RT (SRT) and complex RT (CRT)] were evaluated under four experimental conditions with stimulation (stim) and medication (med) on and off: stim-on/med-on, stim-on/med-off, stim-off/med-off and stim-off/med-on.

The development of a quality system for neuromodulation in the Netherlands.

We present here a descriptive article on the development of a national quality system for neuromodulatory techniques in the Netherlands. In 1994, due to reimbursement difficulties in the Netherlands, a Neuromodulation Working Group (WGN) undertook an initiative to develop a national quality system for neuromodulation. It was believed that with official recognition of neuromodulation as a therapy by the health authorities in the Netherlands, a quality system for monitoring would then follow.

Monopolar versus bipolar high frequency stimulation in the rat subthalamic nucleus: differences in histological damage.

The aim of the present study was to determine the effects of monopolar and bipolar high frequency stimulation (HFS) on histological damage and current flow using a commonly applied stimulus amplitude (300 microA). Bipolar HFS resulted in a large amount of histological damage whereas with monopolar HFS no damage was observed except for the electrode trajectory. Oscilloscopic readings confirmed that this was due to the application of twice as much current to the target with bipolar HFS.

Neuropathic limb pain and spinal cord stimulation: results of the dutch prospective study.

Baseline and 12-month follow-up data from a prospective controlled study on patients treated with SCS for neuropathic limb pain (NLP) are analyzed critically. The outcome on pain, use of medication, and quality of life are reported and compared with the literature. Patients enrolled from April 1999 to December 2001 were part of a quality system study by the Dutch Working Group on Neuromodulation.

Developing a national continuous quality improvement system for neuromodulation treatment in The Netherlands.

Background: Because neuromodulation was not included in the national health insurance system, the Dutch Neuromodulation Group (DNG) developed national standards and a continuous quality improvement (CQI) system for consistency in application of neuromodulation techniques and in the quality of outcomes.

Developing The National Quality Improvement System: A stepwise approach was used in which the following ten steps were taken: (1) selected participating medical specialists and their centers, (2) described the treatment protocol, (3) collected data in a national database, (4) organized feedback sessions for the DNG, (5) formulated quality indicators, (6) adjusted the process of treatment, (7) formalized the structure of the DNG, (8) defined responsibilities, (9) established procedures for future development, and (10) made agreements with payers.

Discussion: Making reimbursement for expensive health care interventions contingent on a national CQI system created a powerful financial incentive to continuously provide effective care in an efficient manner.