Summary:Purpose: Our aim was to evaluate the efficacy of ESCM (electrical stimulation of the centromedian thalamic nucleus) in treatment of generalized seizures of the LennoxGastaut syndrome (LGS) and improvement of patient disability.Methods: Thirteen patients with LGS were studied. They had severe generalized tonic-clonic seizures (GTC) and atypical absences (AA). All patients had at least a 6-month baseline before bilateral electrode implantation to the centromedian (CM) nuclei of the thalamus to undergo therapeutic ESCM. Once implanted, electrodes were temporally externalized through a retromastoid point for electrophysiologic confirmation of their placement. After target confirmation, stimulation parameters were set. Patients came for follow-up assessment of seizures and neurophysiologic tests every 3 months during an 18-month period of time; AED therapy was not modified.Results: The surgical procedure as well as electrical stimulation was well tolerated by all patients. No side effects occurred with the therapeutic stimulation parameters used, and patients were not aware of device activation. Two patients were explanted because of repeated and multiple skin erosions that could not be controlled by plastic surgery procedures. Overall seizure reduction was 80%. The three patients with poorest outcomes for seizure control did not improve their ability scale score. In contrast, the two patients rendered seizure free are living a normal life at present. The remaining eight patients experienced progressive improvement, from being totally disabled to becoming independent in five cases and partially dependent in two. Patients with adequate electrode placement had a seizure reduction >87%. To consider that an electrode is correctly placed, both stereotactic placement and neurophysiologic responses are taken into account.Conclusions: ESCM provides a nonlesional, neuromodulatory method with improvement in seizure outcome and in the abilities of patients with severe LGS.
Five patients with clinical and EEG primary generalized or multifocal uncontrollable seizures underwent stereotaxic implantation of electrodes in both centromedian thalamic nuclei (CM). Each electrode consisted of a semiflexible array of three platinum-iridium wires, isolated except at their tips, which were separated by 4 mm. Bipolar, biphasic rectangular pulses were delivered in trains of 1 min every 5 min, alternating right and left side for sessions 2 h/day. Patients were followed for 3 months with charting of clinical seizures, daily 4-h EEG recordings from scalp and depth for 5 days and weekly thereafter. Baseline and 3-month evaluation of psychological performance through selected Beta R, Wechsler memory scale, visual discrimination, MMPI, and Zung's rated depression scale. Tests were evaluated for significant changes by the parametric student's t test and Mann Whitney nonparametric test. Clinical seizures were significantly reduced by electrical stimulation (ES), as were EEG interictal spikes and EEG slow waves. Psychological performance improved beyond that expected by reduction in seizure activity. ESCM induced a local afterdischarge (AD) that progressively developed in time and intensity, and the beneficial effects outlasted ES for periods of weeks to months, suggesting that a state of hyperexcitability of stimulated tissue, similar to "kindling," was created by chronic ES.
OBJECTIVE:To determine values of simple anthropometric measurements which are associated with the presence of type 2 diabetes mellitus, hypertension and dyslipidaemia and to assess anthropometric cut-off values for predicting the likelihood of these chronic conditions in a Mexican population. DESIGN AND SETTING: The data were obtained from PRIT (Prevalence of Cardiovascular Risk Factors in General Hospital Workers) surveys from 1994 to 2000 adjusted to the structure of the overall Mexican population. SUBJECTS: A total of 2426 men and 5939 women aged 38.99 AE 7.11 and 39.11 AE 14.25 y, respectively. MEASUREMENTS: The optimal sensitivity and specificity of using various cut-off values of BMI (body mass index), WHR (waistto-hip ratio), WC (waist circumference) and WTH (waist-to-height ratio) to predict type 2 diabetes mellitus (DM), hypertension (HT), or dyslipidaemia were examined by receiver operating characteristic curve (ROC) analysis. The likelihood ratios for having diabetes, hypertension and dyslipidaemia in subjects with various cut-off values of BMI, WHR, WC and WTH were calculated. Multiple step-wise logistic regression analysis was used to examine the independent relationship between the anthropometric indexes, age and smoking, and the odds ratio of having chronic conditions. RESULTS: The BMI cut-off to predict DM, HT, or dyslipidaemia varied from 25.2 to 26.6 kg=m 2 in both men and women. The optimal WC cut-offs were 90 cm in men and 85 cm in women. The WHR cut-off was about 0.90 in men and 0.85 in women, and the optimal WTH cut-off was 52.5 in men and varied from 53 to 53.5 in women. The cut-off levels for WC, WHR and WTH corresponded to the inflexion points in the likelihood ratio graphs. In the case of BMI likelihood ratio graphs, we found a significant increase in the risk for chronic conditions from 22 to 23 BMI levels in both genders. Logistic regression analyses disclosed that only BMI and age were included in all the models as well as the influence of smoking in DM and dyslipidaemia in men. CONCLUSION: Although these results may not be readily applied to the rest of the Mexican population or to other Hispanic populations, they point to the necessity of similar studies with large randomized samples to find the cut-off levels for chronic conditions in different populations.
OBJECTIVE: To evaluate the safety and ef®cacy of Sibutramine 10 mg per os, once a day in obese patients over a period of 6 months. DESIGN: A monocenter, double-blind, placebo-controlled, parallel, prospective clinical trial. SUBJECTS: 109 male and female obese patients (BMI b b 30 kgam 2 ) from 16 to 65 y entered the trial. MEASUREMENTS: Body weight, body mass index (BMI), waist and waistahip ratio, medical history, assessment of hunger, satiety and diet compliance, standard laboratory assessments, blood pressure, heart rate and ECG. RESULTS: 40 out of 55 patients in the Sibutramine group and 44 out of 54 patients in the placebo group completed the trial. Using the method of last observation carried forward (LOCF), the weight loss in the Sibutramine group was 7.52 kg (95% con®dence intervals (95% CI) 6.15; 8.9) and that in the placebo group was 3.56 kg (95% CI 2.41; 4.7). The BMI loss was 3.14 kgam 2 (95% CI 2.58; 3.69) in the Sibutramine group and 1.46 kgam 2 (95% CI 0.99; 1.93) in the placebo group. The waist reduction was 12.51 cm (95% CI 9.25; 15.77) in the Sibutramine group and 3.26 cm (95% CI 1.38; 5.14) in the placebo group (P`0.05 by paired Student's t-test for all the intragroup comparisons). 32 Sibutramine patients had 45 adverse events, the most frequent adverse events in the Sibutramine group being dry mouth (n 19), increase in blood pressure (n 5), constipation (n 5) and tachycardia (n 5); 23 placebo patients had 29 adverse events, mainly increase in blood pressure (n 11) and dry mouth (n 10). Two Sibutramine patients withdrew from the trial due to adverse events. CONCLUSION: Sibutramine induces signi®cant loss of body weight, BMI and waist, but does not signi®cantly affect cardiovascular function. Sibutramine was well tolerated by most of the patients.
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