Background Dissociative seizures are paroxysmal events resembling epilepsy or syncope with characteristic features that allow them to be distinguished from other medical conditions. We aimed to compare the effectiveness of cognitive behavioural therapy (CBT) plus standardised medical care with standardised medical care alone for the reduction of dissociative seizure frequency. MethodsIn this pragmatic, parallel-arm, multicentre randomised controlled trial, we initially recruited participants at 27 neurology or epilepsy services in England, Scotland, and Wales. Adults (≥18 years) who had dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous 12 months were subsequently randomly assigned (1:1) from 17 liaison or neuropsychiatry services following psychiatric assessment, to receive standardised medical care or CBT plus standardised medical care, using a web-based system. Randomisation was stratified by neuropsychiatry or liaison psychiatry recruitment site. The trial manager, chief investigator, all treating clinicians, and patients were aware of treatment allocation, but outcome data collectors and trial statisticians were unaware of treatment allocation. Patients were followed up 6 months and 12 months after randomisation. The primary outcome was monthly dissociative seizure frequency (ie, frequency in the previous 4 weeks) assessed at 12 months. Secondary outcomes assessed at 12 months were: seizure severity (intensity) and bothersomeness; longest period of seizure freedom in the previous 6 months; complete seizure freedom in the previous 3 months; a greater than 50% reduction in seizure frequency relative to baseline; changes in dissociative seizures (rated by others); health-related quality of life; psychosocial functioning; psychiatric symptoms, psychological distress, and somatic symptom burden; and clinical impression of improvement and satisfaction. p values and statistical significance for outcomes were reported without correction for multiple comparisons as per our protocol. Primary and secondary outcomes were assessed in the intention-to-treat population with multiple imputation for missing observations. This trial is registered with the International Standard Randomised Controlled Trial registry, ISRCTN05681227, and ClinicalTrials.gov, NCT02325544.
The dual anti-platelet regime has a significant impact on reducing adverse neurological outcomes without an additional increase in bleeding complications. This study was terminated prematurely due to an unacceptable level of complications in the heparin arm of the trial.
Background: Our aim was to determine whether filter protection reduces embolisation to the brain during carotid artery stenting (CAS). Methods: Thirty patients with symptomatic carotid artery stenosis ≧70% (North American Symptomatic Carotid Endarterectomy Trial) were randomly assigned to filter-protected or unprotected CAS. Diffusion-weighted magnetic resonance imaging (DWI) of the brain was performed before and at 3 time points after CAS. In a subset of patients, high-intensity transient signals on transcranial Doppler (TCD) were recorded with categorisation of emboli. Data were independently reviewed off-site. Results: There were no significant differences in mean age, proportion of octogenarians or presenting symptoms between the groups. On procedural DWI (1–3 and 24 h after stenting), there were 7/24 (29%) and 4/22 (18%) new lesions in protected and unprotected patients respectively (p = 0.38). At 30 days there were 9/33 (26%) and 4/33 (12%) lesions in protected and unprotected patients, respectively (p = 0.1). On TCD there were significantly more signals in total as well as particulate emboli during filter-protected CAS (426.5 and 251.3) than during unprotected CAS (165.2 and 92) – p = 0.01 and 0.03, respectively. Conclusions: Filter-protected CAS is associated with an increase in new lesions on DWI and significantly higher rates of total and particulate microembolisation on TCD than unprotected CAS. The clinical significance of these findings requires further study.
Background and Purpose-Carotid intervention by carotid endarterectomy (CEA) or endovascular treatment may cause hemodynamic change. The immediate and long-term effects on blood pressure after these procedures were assessed. Methods-Patients were randomized to CEA (nϭ49) or endovascular treatment (nϭ55) that comprised percutaneous transluminal angioplasty alone (nϭ31), balloon-expandable stent (nϭ13), or self-expandable stent (nϭ11). A baseline 24-hour ambulatory blood pressure recording was made before carotid intervention and repeated at 24 hours, 1 month, and 6 months after the procedure. Results-In the first 24 hours after the procedure, episodes of hypotension occurred in 75% of the CEA group and 76% of the endovascular group; hypertension occurred in 11% and 13%, respectively. There was a significant fall in blood pressure at 1 hour after the procedure in both groups (24 and 16 mm Hg fall in CEA and endovascular groups, respectively), but this was only sustained in the endovascular group. The pattern of blood pressure response in the first 24 hours was significantly different (PϽ0.0001, ANCOVA). Systolic blood pressure was significantly lower at 1 and 6 months only in the surgical group (6 and 5 mm Hg fall, respectively). Conclusions-Both
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