Persistent dysphagia after laser uvulopalatoplasty: a videoradiographic study of pharyngeal function

In a follow-up study of 79 patients two years after laser uvulopalatoplasty 21 (27%) reported persistent postoperative dysphagia, with aspiration symptoms in 22%. None of the patients had suffered from recurrent pneumonia. A total of 4% of the patients regretted the treatment because of their dysphagia problems. The objective of this study was to examine oral and pharyngeal function videoradiographically during swallowing in the patients with persistent dysphagia, to determine whether the subjective symptoms of dysphagia correlated with objective signs of pharyngeal dysfunction. Pharyngeal function during swallowing was deviant in 76% of the dysphagic patients. In 52% of the dysphagic patients premature leakage of bolus down to different levels of the pharynx, from the tongue base to sinus piriformis, was observed before the swallowing reflex was elicited. In the dysphagic patients substantial bolus retention was observed on the epiglottis or in the valleculae alter the propagation wave had passed (43%) as well as epiglottal dysmotility (24%). Of the dysphagic patients, 10% could not avoid aspiration during the examination. These findings could explain the symptoms reported by the patients.     

Diagnosis of stroke by the nonneurologist. A validation study

BACKGROUND AND PURPOSE: The first medical contact of an acute stroke victim is often a nonneurologist. Validation of stroke diagnosis made by these medical doctors is poorly known. The present study seeks to validate the stroke diagnoses made by general practitioners (GPs) and hospital emergency service physicians (ESPs). METHODS: Validation through direct interview and examination by a neurologist was performed for diagnoses of stroke made by GPs in patients under their care and doctors working at the emergency departments of 3 hospitals. RESULTS: Validation of the GP diagnosis was confirmed in 44 cases (85%); 3 patients (6%) had transient ischemic attacks and 5 (9%) suffered from noncerebrovascular disorders. Validation of the ESP diagnosis was confirmed in 169 patients (91%); 16 (9%) had a noncerebrovascular diagnosis. Overall, the most frequent conditions misdiagnosed as stroke were neurological in nature (cerebral tumor, 3; subdural hematoma, 1; seizure, 1; benign paroxysmal postural vertigo, 1; peripheral facial palsy, 2; psychiatric condition, 6; and other medical disorders, 7). CONCLUSIONS: In the majority of cases, nonneurologists (either GPs or ESPs) can make a correct diagnosis of acute stroke. Treatment of acute stroke with drugs that do not cause serious side effects can be started before evaluation by a neurologist and CT scan.     

Role of fine-needle aspiration biopsy and frozen section examination in determining the extent of thyroidectomy

Ten years' experience with neonatal necrotizing enterocolitis (NNEC) was reviewed retrospectively to determine long-term survival and quality of life and to analyze risk factors associated with in-hospital mortality. Institutional records were queried to identify all neonates who required emergent surgical intervention for NNEC. These records were then reviewed and survivors' families interviewed by phone to determine patient status, persistent gastrointestinal problems, and overall quality of life. Once identified, long-term survivors (LTSs) were compared to in-hospital deaths by the analysis of birth weight, gestational age, time interval from birth to diagnosis, indications for laparotomy, and extent of intestinal involvement. Between 1986 and 1996, 69 patients required surgical intervention for NNEC. Eleven patients were lost to follow-up. Of the remaining 58 patients, 31 were ultimately discharged home, with 28 patients having survived an average of 4.18 years. The acute, or in-hospital, mortality rate was 39.1 per cent. Infants who died did so within an average of 23 days postoperatively, and those who were discharged home required an average of 121 days of inpatient convalescence. Twenty-one of the 28 LTSs achieved a normal quality of life with no persistent health problems. One patient required a hepatic-intestinal transplant, and another six had minor problems with frequent diarrhea. Average birth weight, age at NNEC diagnosis, and gestational age were not significantly different between LTSs and those with acute deaths. Aggressive in-hospital care is warranted for infants with NNEC. The excellent quality of life achieved in 75 per cent of survivors implies that the expense of heroic surgical care for these seriously ill premature infants is a worthwhile investment.     

Vestibular nucleus neurons, projecting to the "gastric" area of the solitary tract nucleus

OBJECTIVES: To describe the natural recovery of visuospatial neglect in stroke patients and the distribution of errors made on cancellation tests using a standardised neuropsychological test battery. METHOD: A prospective study of acute (< seven days) patients with right hemispheric stroke. Patients identified with visuospatial neglect were followed up for three months with monthly clinical and neuropsychological testing RESULTS: There were 66 patients with acute right hemispheric stroke assessed of whom 27 (40.9%) had evidence of visuospatial neglect. Patients with neglect, on admission, had a mean behavioural inattention test (BIT) score of 56.3, range 10-126 (normal>129). Three of the subtests identified errors being made in both the right and left hemispaces. During follow up, recovery occurred across both hemispaces, maximal in the right hemispace. Recovery from visuospatial neglect was associated with improvement in function as assessed by the Barthel score. At the end of the study period only six (31.5%) patients had persisting evidence of neglect. On admission the best predictor of recovery of visuospatial neglect was the line cancellation test (Spearman's rank correlation r=-0.4217, p=0.028). CONCLUSION: The demonstration of errors in both hemispaces has implications for the theory that neglect is a lateralised attentional problem and is important to recognise in planning the rehabilitation of stroke patients.     

Identifying hypoxic tissue after acute ischemic stroke using PET and 18F-fluoromisonidazole

OBJECTIVE: To show that PET with 18F-fluoromisonidazole (18F-FMISO) can detect peri-infarct hypoxic tissue in patients after ischemic stroke. BACKGROUND: PET with (15)O-labeled oxygen and water is the only established method for identifying the ischemic penumbra in humans. We used PET with 18F-FMISO in patients after ischemic stroke to identify hypoxic but viable peri-infarct tissue likely to represent the ischemic penumbra, and to determine how long hypoxic tissues persist after stroke. METHODS: Patients with acute hemispheric ischemic stroke were studied using PET with 18F-FMISO either within 48 hours or 6 to 11 days after stroke onset. The final infarct was defined by CT performed 6 to 11 days after stroke. Tracer uptake was assessed objectively by calculating the mean activity in the contralateral (normal) hemisphere, then identifying pixels with activity greater than 3 SDs above the mean in both hemispheres. Positive studies were those with high-activity pixels ipsilateral to the infarct. RESULTS: Fifteen patients were studied; 13 within 48 hours of stroke, 8 at 6 to 11 days, and 6 during both time periods. Hypoxic tissue was detected in 9 of the 13 patients studied within 48 hours of stroke, generally distributed in the peripheries of the infarct and adjacent peri-infarct tissues. None of the 8 patients studied 6 to 11 days after stroke exhibited increased 18F-FMISO activity. All 6 patients studied both early and late exhibited areas of increased activity during the early but not the late study. CONCLUSIONS: PET with 18F-FMISO can detect peri-infarct hypoxic tissue after acute ischemic stroke. The distribution of hypoxic tissue suggests that it may represent the ischemic penumbra. Hypoxic tissues do not persist to the subacute phase of stroke (6 to 11 days).     

Prosthesis jump graft: an unusual arterial reconstruction in liver transplantation

PURPOSE: To investigate through the use of cerebral Doppler technology whether emboli are a more common cause of nonarteritic anterior ischemic optic neuropathy (NAION) than previously recognized. METHODS: Eleven patients with a recent (<121 days) history of nonarteritic anterior ischemic optic neuropathy and 10 age-matched controls (event > 121 days) were examined using a Nicolet Pioneer 2020 transcranial Doppler (TCD) unit with a 2-MHz bilateral continuous monitoring capability. The right and left middle cerebral arteries were evaluated simultaneously for 30 minutes at a depth of 50 to 55 mm, and the number of emboli, blood flow velocities, and pulsatility indices were recorded. Data were stored by computer, and hard-copy color recordings were made. RESULTS: None of 11 patients with a recent history of NAION demonstrated microemboli by TCD examination. One patient in the control group who had a remote history of NAION had a microembolic event rate of 12 per hour (six over 30 minutes). This patient had a history of prosthetic cardiac valve replacement and was taking anticoagulation medication at the time of the examination. CONCLUSIONS: Our study did not reveal an increased incidence of embolic events in patients with NAION when they were examined in a transcranial Doppler study of the middle cerebral arteries. This study does not support embolism as a frequent cause of NAION.     

Functionalization of nucleoside analogs: regiospecific conversion of 4"-hydroxyl groups to thioesters and deoxygenation of 3''-hydroxyl groups

BACKGROUND AND PURPOSE: We have previously shown that treatment of acute stroke patients in the combined acute and rehabilitation stroke unit in our hospital improves survival and functional outcome compared with treatment in general wards. The primary aim of the present trial was to examine whether the treatment in our stroke unit had an effect on different aspects of quality of life (QoL) for stroke patients 5 years after the onset of stroke. METHODS: In a randomized controlled trial, 110 patients with symptoms and signs of an acute stroke were allocated to the stroke unit and 110 to general wards. No significant differences existed in baseline characteristics between the two groups. The patients alive after 5 years were assessed by the Nottingham Health Profile (NHP) and the Frenchay Activities Index (FAI), which were the scales used as primary outcome measures for QoL. As secondary outcome measures we used a global score for the NHP and a simple visual analogue scale (VAS). RESULTS: After 5 years, 45 of the patients treated in the stroke unit and 32 of those treated in general wards were alive. All surviving patients were assessed by the FAI. Thirty-seven (82.2%) of the stroke unit patients and 25 (78.1%) of the general wards patients were assessed by the NHP; 38 (84.4%) and 28 (87.5%), respectively, were assessed by the VAS. Patients treated in the stroke unit had a higher score on the FAI (P=0.0142). Assessment with the NHP showed better results in the stroke unit group for the dimensions of energy (P=0.0323), physical mobility (P=0.0415), emotional reactions (P=0.0290), social isolation (P=0.0089), and sleep (P=0.0436), although there was no difference in pain (P=0.3186). The global NHP score and VAS score also showed significantly better results in the stroke unit group (NHP, P<0.01; VAS, P<0.001). Patients who were independent in activities of daily living had significantly better QoL assessed by these scales than patients who were dependent. CONCLUSIONS: Our study shows for the first time that stroke unit care improves different aspects of long-term QoL for stroke patients.     

Cardiac troponin-I accurately predicts myocardial injury in renal failure

BACKGROUND: Non-specific elevations of creatine kinase isoenzymes (CK-MB) and cardiac troponin-T may be seen in renal failure, confusing the diagnosis of myocardial infarction. Cardiac troponin-I (cTn-I) has been shown to be specific for myocardial damage in several disease states, but has not been prospectively evaluated in the setting of renal failure. METHODS: This prospective case series evaluated 56 patients with acute or chronic renal failure or end-stage renal disease to assess the sensitivity and specificity of cTn-I for detecting myocardial injury in this patient population. During a 6-month period, patients admitted with suspected myocardial injury by history, physical examination, and electrocardiography were evaluated. Cardiac troponin-I (cTn-I) measurements were assessed between 8 and 48 h after admission. Appropriate medical care and further cardiac testing (echocardiography, stress testing, or arteriography) was performed at the discretion of the primary physician. RESULTS: Myocardial injury was diagnosed in 18/56 (32%) patients by positive cTn-I levels, while only 7/56 (13%) patients had evidence of myocardial damage by CK-MB. Twenty-one of 56 (38%) patients had indeterminate CK-MB levels and 53% of these patients demonstrated myocardial ischaemia on follow-up testing. Sixteen patients had negative cardiac studies; all of these patients had negative cTn-I levels, while seven of these 16 (44%) patients had indeterminate CK-MB measurements. All of the patients with positive cTn-I levels had positive cardiac studies. Positive troponin levels were associated with increased in-hospital mortality. Sensitivity and specificity for CK-MB were 44 and 56% respectively, and 94 and 100% for cTn-I. CONCLUSION: These data support the use of cTn-I for diagnosing myocardial injury in patients with renal failure. Elevated cTn-I levels are associated with increased short-term mortality in renal failure patients. The accuracy of cTn-I could potentially limit unnecessary cardiac testing in renal failure patients, while the enhanced sensitivity contributes to risk stratification and aids in diagnosing true myocardial injury in this population susceptible to non-specific elevations in other muscle enzymes.     

Importance of fats as energy supply, membrane building blocks and immunomodulators in parenteral nutrition

We assessed the use of cranial computed tomography (CT) in elderly patients with acute neurological deficit and its influence on patient management. Clinical notes from 100 consecutive CT referrals from geriatric admissions presenting with acute neurological deficit were reviewed and categorized according to clinical presentation. CT results and subsequent therapy were recorded. Twenty of the patients had treatable lesions (in 6 out of 14 patients with signs atypical of stroke and 7 out of 19 patients with acute confusion). These two groups contained 68% of all treatable lesions found. Forty-four scans yielded no new diagnostic information; these included all scans for transient ischaemic attacks and for progression of stroke. The remaining scans yielded information regarding pathology but did not alter patient management. CT is a valuable first-line investigation in elderly patients presenting with signs atypical of stroke and unexplained confusion but may be less useful in patients with other presentations.     

Malnutrition in geriatric patients: a neglected problem?

PURPOSE: The authors report their experience with the translumbar inferior vena cava (IVC) approach for central venous access during a 6-year period at three teaching hospital sites. PATIENTS AND METHODS: Twenty-nine percutaneous IVC central venous access catheters were inserted in 22 patients during a 6-year period in the radiology departments of three teaching hospital sites. All patients had undergone unsuccessful attempts at conventional central venous access. Information was gathered by retrospective radiologic and hospital chart review. RESULTS: All attempted placements were successful. Catheters were in place for a total of 3,510 catheter days. The average length of catheter placement was 121 days (range, 14-536 days). Life-table analysis predicted catheter function rates of 55% and 29% at 6 and 12 months, respectively. Three procedure-related complications occurred. A lower pole branch of the right renal artery was inadvertently entered with a 22-gauge needle during attempted IVC puncture in one patient without clinical sequelae. A second patient developed a small groin hematoma at the femoral venous puncture site, which resolved spontaneously. A third patient developed a moderate retroperitoneal hematoma, which resolved without specific intervention. The sepsis rate was 2.8 infections per 1,000 catheter days with an average time to infection of 127 days (range, 10-536 days). CONCLUSION: In the authors' experience of 29 translumbar central venous catheter insertions, all attempts were successful. Percutaneous central venous access via the IVC is a safe and effective option for patients in whom more conventional access is not possible.     

Surgical interventions in the treatment of Parkinson's disease (PD) and essential tremor (ET): medial pallidotomy in PD and chronic deep brain stimulation (DBS) in PD and ET

Surgical treatments for PD and ET are promising. Medial Pallidotomy, the surgical lesioning of the pallidum, often improves symptoms of long-standing PD. We enrolled twenty-seven late stage PD patients for unilateral medial pallidotomy who were then assessed by the Core Assessment Program for Intracranial Transplantation (CAPIT) protocol. One year after surgery persistent improvement was seen contralateral to the lesion in the following features: drug-induced dyskinesias (92%), akinesia (38%), rigidity (51%), and tremor (42%). Complications included transient dysarthria (7 patients), facial weakness (9 patients), limb weakness (1 patient), swallowing problems (4 patients) and intracerebral haemorrhage (1 patient). Thalamic DBS may improve tremor in PD and ET patients. Therefore, we enrolled fifteen patients (9 PD and 6 ET patients) with disabling tremor, unresponsive to medication. They were assessed by the United Parkinson's Disease Rating Scale (UPDRS) and the Tremor Rating Scale (for PD and ET patients, respectively). Three months after surgery, limb tremor contralateral to stimulation improved by 71% in PD patients and 76% in ET patients. Complications included transient paresthesias (all), confusional state (1 patient) and intracerebral bleed (1 patient). Unilateral medial pallidotomy safely improves some Parkinsonian symptoms contralateral to the lesion. Thalamic DBS may effectively and safely improve contralateral limb tremor in PD and ET.     

Effect of malnutrition after acute stroke on clinical outcome

BACKGROUND AND PURPOSE: Malnutrition has received little attention in acute stroke, although it represents a risk of decreased immunity and nosocomial infections. Our objectives were to determine the prevalence of malnutrition after 1 week of hospitalization in acute stroke and to establish its relation to the stress response and neurological outcome. METHODS: The study included 104 patients with an acute stroke of less than 24 hours' duration. Nutritional parameters (triceps skinfold thickness, midarm muscle circumference, serum albumin, and calorimetry) were evaluated at admission and after 1 week. Stress response (free urinary cortisol) was measured daily during the first week. Neurological deficit was evaluated by the Canadian Stroke Scale. Clinical outcome was estimated by the Barthel Index 1 month after the acute stroke. Patients received an oral standard diet or polymeric enteral nutrition when they had swallowing difficulties. RESULTS: Protein-energy malnutrition was observed in 16.3% of patients at inclusion and in 26.4% after the first week, with a significant decrease in fat (P = .002) and visceral protein compartments (P = .049). Malnourished patients showed higher stress reaction and increased frequency of infections and bedsores in comparison with the appropriately nourished group. Multiple logistic regression analysis showed that malnutrition after 1 week (odds ratio, 3.5; 95% confidence interval, 1.2 to 10.2) and elevated free urinary cortisol (odds ratio, 3.3; confidence interval, 1.05 to 10.2) increased the risk of poor outcome (death or Barthel Index < or = 50 on the 30th day of follow-up) independently of age and nutritional status at admission. CONCLUSIONS: Our findings suggest that protein-energy malnutrition after acute stroke is a risk factor for poor outcome. Early appropriate enteral caloric feeding did not prevent malnutrition during the first week of hospitalization.     

Soluble adhesion molecules reflect endothelial cell activation in ischemic stroke and in carotid atherosclerosis

BACKGROUND AND PURPOSE: Activation of endothelial cells and platelets plays an important role in the development of atherosclerosis and thrombotic disorders. Soluble adhesion molecules originating from these cells can be demonstrated in plasma. We hypothesized that elevated plasma concentrations of soluble P-selectin (sP-selectin), soluble intercellular adhesion mole-cule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), and soluble E-selectin (sE-selectin) can reflect activation of endothelial cells and/or platelets in acute ischemic stroke and in previously symptomatic internal carotid artery stenosis. METHODS: Plasma was sampled from patients within 2 days of acute ischemic stroke (n = 28), from patients with a previous (> 1 week) transient or persistent ischemic neurological deficit associated with stenosis of the internal carotid artery (n = 34), and from control patients without a history of vascular disease (n = 34). Concentrations of sP-selectin, sICAM-1, sVCAM-1, and sE-selectin were measured by means of an enzyme-linked immunosorbent assay. RESULTS: Compared with control subjects, sP-selectin and sE-selectin were significantly elevated in the acute stage of ischemic stroke (P < .0001 and P = .001, respectively) as well as in previously symptomatic carotid stenosis (P < .0001 and P = .0007). sICAM-1 and sVCAM-1 were not increased. CONCLUSIONS: The elevated levels of sE-selectin indicate that endothelial cell activation occurs both in the acute stage of ischemic stroke and in previously symptomatic carotid atherosclerosis. Increased sP-selectin concentrations reflect endothelial cell activation as well but may also be caused by platelet activation.     

Prognostic value of the clinical examination of the diabetic foot ulcer

OBJECTIVE: To determine the value of the history, physical examination, and magnetic resonance imaging (MRI) in predicting successful primary healing of a foot ulcer in a diabetic patient. DESIGN: Prospective cohort study. SETTING: Durham (NC) Veterans Affairs Medical Center. PATIENTS: Sixty-four consecutive diabetic patients with 78 dermal ulcers through the full thickness of the skin and at or distal to the malleoli of the ankle. MEASUREMENTS AND MAIN RESULTS: A structured clinical history and physical examination were performed by two examiners, a physician participating in the study and the referring physician. Fifty of these patients with 63 ulcers underwent MRI. Patients were followed prospectively for 6 months after enrollment to ascertain healing of the ulcer, amputation, and death. During the 6-month follow-up period, 8 (13%) of the patients died. Seventeen (22%) of the ulcers were amputated, 17 (22%) of the ulcers failed to heal, and 36 (47%) healed primarily. Univariate predictors of healing at 6 months included age less than 65 years, diagnosis of diabetes within the last 15 years, painless ulcer, palpable ankle pulse, anklebrachial index greater than 0.5, and the physician's assessment of the overall likelihood of osteomyelitis. In a multivariable logistic regression model, predictors of healing included the presence of an audible pulse on Doppler examination (p = .01) and a painless ulcer (p = .04). The diagnosis of osteomyelitis on MRI did not predict healing in these patients. CONCLUSIONS: Foot ulcers in patients with diabetes frequently have poor outcomes; fewer than half the patients in this study healed their ulcers within 6 months. The vascular components of the clinical examination are the best predictors of healing in patients with a diabetic foot ulcer.     

Results of nonoperative management of full-thickness tears of the rotator cuff

The results of nonoperative management of 53 patients with full-thickness tears of the rotator cuff proven by arthroscopic examination was as follows. Patients were treated with nonsteroidal antiinflammatory medication, stretching, strengthening, and occasional steroid injections. Average age at presentation was 62.2 years. Patients were evaluated at an average of 7.6 years. Forty patients were male, and the dominant limb was involved in 40 cases. Thirty-four patients were reviewed by questionnaire and physical examination, whereas 19 patients were evaluated by telephone interview only. In 40 patients, the onset of symptoms was associated with an injury. In 12 patients, workmen's compensation was involved. At follow-up evaluation, the 34 shoulders that were available for examination were evaluated for pain, range of motion, strength, and function. Thirty-nine of the 53 patients (74%) assessed subjectively had only slight or no shoulder discomfort. Of the 28 shoulders presenting within three months of injury, 24 (86%) were rated as satisfactory at the time of latest evaluation. Of the 16 patients who initially had had shoulder pain for over 6 months, only nine (56%) were rated as satisfactory. Most patients showed improvement with regard to their ability to perform activities of daily living. Average active total elevation was 149 degrees compared with 121 degrees at initial presentation. Thirty-two of the 34 patients examined (94%) had evidence of weakness on muscle testing and 19 (56%) had demonstrable muscle atrophy.     

The influence of diabetes on neurological outcome and mortality in stroke patients

In a retrospective study of diabetic and non-diabetic patients with acute ischaemic stroke, mortality and neurological outcome were assessed. Mortality was determined 4 weeks after admission. The study population consisted of the consecutive patients (n = 609) admitted to the Department of Neurology with acute stroke between January 1994 and December 1995. There were 80 diabetic and 529 non-diabetic patients. The mortality rate was higher in diabetics (36.3%) than in non-diabetics (27%), but the difference was not significant (p = 0.08). The neurological status on admission, age, history of arterial hypertension, atrial fibrillation and coronary arterial disease were used to select groups of 41 diabetics and 84 non-diabetics with similar risk factors and similar onset of stroke. The neurological status on 10-th, 20-th and 28-th day of the hospital stay in both groups was compared. The study showed that insulin-dependent diabetics and older patients (above 65 years of age) with diabetes demonstrated a worse neurological outcome than non-diabetic patients, although the difference was not significant.     

Strain relatedness in persistent and recurrent candiduria

PURPOSE: We assessed the value of determining strain relatedness in differentiating persistent from recurrent candiduria. MATERIALS AND METHODS: Prospective monitoring of patients with candiduria (10(4) or greater colony forming units per ml.) during a 5-month period. All patients with persistent or recurrent infection after documented clearance were selected. Pair isolates were typed using restriction endonuclease analysis of genomic deoxyribonucleic acid with SfiI. Isolates were considered related if all deoxyribonucleic acid bands matched. RESULTS: We encountered 22 and 5 patients with persistent and recurrent infection, respectively. The isolates were recovered 1 to 140 days apart (21.56 +/- 28.97). Most patients were women (85.2%) with a mean age of 66.41 +/- 18.11 years. Risk factors included antibiotics (100%), indwelling catheter (88.9%) and diabetes mellitus (40.7%). Of 15 individuals who received antifungal therapy candiduria persisted in 10 and resolved but recurred within 4 to 26 days (13.00 +/- 9.08) after treatment in 5. Candida albicans accounted for 34 of 58 isolates (58.6%), and it was mixed with other species in 4 cultures. Paired strains were genetically identical in 26 of 27 patients. Strain persistence was documented in 21 of 22 cases with persistent infection and in all 5 patients with recurrent disease. CONCLUSIONS: These findings show that strain persistence is exceedingly frequent in candiduria. These results imply that determining strain relatedness of Candida urinary isolates may not be reliable in differentiating persistent from recurrent infection.     

Lubeluzole treatment of acute ischemic stroke. The US and Canadian Lubeluzole Ischemic Stroke Study Group

BACKGROUND AND PURPOSE: Lubeluzole is a novel benzothiazole compound that has shown neuroprotective activity in preclinical models of ischemic stroke. The present multicenter, double-blind, placebo-controlled study was conducted to assess the efficacy and safety of lubeluzole in the treatment of ischemic stroke. METHODS: Seven hundred twenty-one patients with clinical symptoms of acute ischemic stroke were randomized to receive either lubeluzole (7.5 mg over 1 hour, followed by a continuous daily infusion of 10 mg for up to 5 days) or placebo. Treatment was initiated within 6 hours of symptom onset. Mortality at 12 weeks was the primary efficacy end point. Secondary efficacy end points included neurological recovery (based on the National Institutes of Health Stroke Scale [NIHSS]), functional status (based on the Barthel Index), and level of disability (based on the Rankin Scale). Safety assessments included standard and continuous electrocardiographic monitoring, physical examination, measurements of vital signs, clinical laboratory evaluation, and adverse events reports. RESULTS: The overall mortality rate at 12 weeks for lubeluzole-treated patients was 20.7% compared to 25.2% for placebo-treated patients (NS). Controlling for relevant covariates, the degree of neurological recovery (NIHSS) at week 12 significantly favored lubeluzole over placebo (P = .033). Lubeluzole treatment similarly resulted in significantly greater improvements in functional status (Barthel Index) (P = .038) and overall disability (Rankin Scale) (P = .034) after 12 weeks. A global test statistic confirmed that lubeluzole-treated patients had a more favorable clinical outcome at 12 weeks (P = .041). The safety profile of lubeluzole resembled that of placebo. CONCLUSIONS: Treatment with lubeluzole within 6 hours of the onset of ischemic stroke had a nonsignificant effect on mortality and resulted in improved clinical outcome compared with placebo, with no safety concerns.     

Prognostic significance of electrophysiological investigations in stroke patients: somatosensory and motor evoked potentials and sympathetic skin response

A prospective 3-month follow-up examination was carried out in 12 patients with supratentorial stroke. Motor evoked potentials (MEP), somatosensory evoked potentials (SEP) and sympathetic skin responses (SSR) were performed 1-7 days, 30 days and 3 months after stroke. The functional outcome measured by a daily activity index (Barthel index) was assessed 3 months after the stroke. There was a significant correlation between SEP and MEP results obtained for the first week and recovery of sensation and motility 3 months later. When initially normal, motor potentials evoked by transcranial magnetic stimulation had a significant predictive value for long-term functional outcome, whereas SEP and SSR did not. SSR present at the initial stage was correlated with the state of consciousness.