Use of Sham Interventions in Randomized Controlled Trials in Neurosurgery.

BACKGROUND: The use of sham interventions in randomized controlled trials (RCTs) is essential to minimize bias. However, their use in surgical RCTs is rare and subject to ethical concerns. To date, no studies have looked at the use of sham interventions in RCTs in neurosurgery. METHODS: This study evaluated the frequency, type, and indication of sham interventions in RCTs in neurosurgery. RCTs using sham interventions were also characterized in terms of design and risk of bias. RESULTS: From a total of 1,102 identified RCTs in neurosurgery, 82 (7.4%) used sham interventions. The most common indication for the RCT was the treatment of pain (67.1%), followed by the treatment of movement disorders and other clinical problems (18.3%) and brain injuries (12.2%). The most used sham interventions were saline injections into spinal structures (31.7%) and peripheral nerves (10.9%), followed by sham interventions in cranial surgery (26.8%), and spine surgery (15.8%). Insertion of probes or catheters for a sham lesions was performed in 14.6%.In terms of methodology, most RCTs using sham interventions were double blinded (76.5%), 9.9% were single blinded, and 13.6% did not report the type of blinding. CONCLUSION: Sham-controlled RCTs in neurosurgery are feasible. Most aim to minimize bias and to evaluate the efficacy of pain management methods, especially in spinal disorders. The greatest proportion of sham-controlled RCTs involves different types of substance administration routes, with sham surgery the less commonly performed.

Electronic search strategies fail to identify randomized controlled trials (RCTs) in neurosurgery.

Randomized controlled trials (RCTs) are the gold standard studies to evaluate the efficacy of therapeutic interventions. Although they are frequently identified through open searches in electronic databases, no studies have evaluated how easy it is to identify RCTs in neurosurgery using electronic search strategies. The present study evaluated the sensitivity and specificity of different search strategies applied to commonly used databases to identify RCTs in neurosurgery. The total number of RCTs in neurosurgery published between 1960 and 2013 was determined through a detailed search involving open keyword searches in PubMed, Cochrane Library and Center for Reviews and Dissemination (CRD) databases, a PubMed search based on clinical entity-related keywords and hand-searches on the reference list of identified articles. The sensitivity and specificity were calculated for the open keyword searches on PubMed, the Cochrane Library and the CRD database and for the Cochrane's HSSS, based on the total number of the identified RCTs. Compared to the total of 1102 RCTs identified, PubMed open search yielded 4660 articles, among which 365 were RCTs (sensitivity: 33.1%; specificity: 7.8%). Cochrane open search yielded 621 among which 36 were RCTs (sensitivity: 3.2%; specificity: 5.8%) and CRD open search returned 78 articles, among which 4 were RCTs (sensitivity: 0.4% sensitivity; specificity: 5.1%). The Cochrane HSSS retrieved 10702 results, among which 340 were RCTs (sensitivity: 30.9%; specificity: 3.2%). Most RCTs in neurosurgery cannot be identified by commonly used search strategies, which emphasizes the need to improve their indexing.

Stimulation of the bilateral anterior nuclei of the thalamus in the treatment of refractory epilepsy: two cases of subcortical band heterotopia.

Subcortical band heterotopia is a neuronal migration disorder that may cause refractory epilepsy. In these patients, resective surgery has yielded inadequate results. Deep brain stimulation of the anterior nuclei of the thalamus has been used for the treatment of refractory epilepsy with good results. We describe the first two patients with subcortical band heterotopia who were submitted to deep brain stimulation of the anterior nuclei of the thalamus, with evaluation of seizure outcome after 12 and 18 months of follow-up. At these times, both showed a >50% decrease in seizure frequency and an increase in seizure freedom. Both patients had a depressive syndrome after surgery that responded fully to anti-depressive medication in one patient and partly in the other. In both, deep brain stimulation of the anterior nuclei of the thalamus was associated with good seizure outcome. This procedure can therefore be considered in the treatment of patients with subcortical band heterotopia and refractory epilepsy. Depression may be a transient adverse event of the surgery or stimulation, however, its aetiology is probably multifactorial.

The human nucleus accumbens: where is it? A stereotactic, anatomical and magnetic resonance imaging study.

Objectives. Identification, delimitation, and stereotactic localization of the human nucleus accumbens (Acc) in order to allow its accurate definition and three-dimensional targeting on magnetic resonance imaging (MRI) enabling its use for deep brain stimulation. Methods. Magnetic resonance imaging and anatomical coronal serial cuts were performed on 24 Acc from human cadaver brains perpendicular to the anterior commissure-posterior commissure line; identification, localization, and determination of its dimensions and three-dimensional stereotactic coordinates. Results. Twenty Acc were studied anatomically, 14 by MRI and 12 by both methods. The contours of the Acc were traced and the dimensions measured; mean values: length 10.5 mm, width 14.5 mm and height 7.0 mm. The stereotactic coordinates were obtained every millimeter along its length. Conclusion. It was possible to identify well the human Acc, define its limits and establish its three-dimensional coordinates as potential MRI-guided stereotactic target.