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PubMed2004

Has your patient's multiple sclerosis lesion burden or brain atrophy actually changed?

Changes in mean magnetic resonance imaging (MRI)-derived measurements between patient groups are often used to determine outcomes in therapeutic trials and other longitudinal studies of multiple sclerosis (MS). However, in day-to-day clinical practice the changes within individual patients may also be of interest In this paper, we estimated the measurement error of an automated brain tissue quantification algorithm and determined the thresholds for statistically significant change of MRI-derived T2 lesion volume and brain atrophy in individual patients. Twenty patients with MS were scanned twice within 30 min. Brain tissue volumes were measured using the computer algorithm. Brain atrophy was estimated by calculation of brain parenchymal fraction. The threshold of change between repeated scans that represented statistically significant change beyond measurement error with 95% certainty was 0.65 mL for T2 lesion burden and 0.0056 for brain parenchymal fraction. Changes in lesion burden and brain atrophy below these thresholds can be safely (with 95% certainty) explained by measurement variability alone. These values provide clinical neurologists with a useful reference to interpret MRI-derived measures in individual patients.

Algorithms↗

PubMed2004

Multiple Sclerosis Impact Scale (MSIS-29): relation to established measures of impairment and disability.

OBJECTIVE: To validate the newly developed Multiple Sclerosis Impact Scale (MSIS-29) in a large, well characterized, independent group of MS patients by investigating the relation between the MSIS-29 and the Guy's Neurological Disability Scale (GNDS), the Expanded Disability Status Scale (EDSS) and the MS Functional Composite (MSFC). METHODS: Two hundred MS patients were recruited at our outpatient department. At the same visit GNDS, EDSS, MSFC and MSIS-29 were assessed. Data obtained from GNDS, EDSS and MSFC assessment were compared to both physical and psychological impact scores of the MSIS-29. In addition the contribution of GNDS subcategories, EDSS functional systems and MSFC components to the physical and psychological impact scores of the MSIS-29 was studied. RESULTS: Median scores were 37.5 for the physical and 22.2 for the psychological impact score of the MSIS-29, 13.0 for GNDS and 4.0 for EDSS. Mean MSFC was 0.07. The physical impact score showed good correlations with both GNDS (0.79) and EDSS (0.68) and a moderate correlation with the MSFC (-0.53). The psychological impact score showed weak correlations with EDSS (0.22) and MSFC (-0.30) and a moderately strong correlation with the GNDS (0.58). In 50 (25%) patients, scores on physical and psychological impact scales diverted, i.e., a relative high score on one scale combined with a relative low score on the other scale. This was related to the clinical disease course. CONCLUSION: Our study supports the use of the MSIS-29 as a measure for the assessment of physical impact of MS on normal daily life. In addition, our data provides a deeper understanding of the factors that determine both physical and psychological disease impact. Discrepancies between the latter two aspects deserve further attention.

Adult↗

PubMed2004

Regulation of differentiation and functional properties of monocytes and monocyte-derived dendritic cells by interferon beta in multiple sclerosis.

Interferon beta (IFN beta) has complex immune regulatory properties that contribute to its treatment effect on multiple sclerosis (MS). In this study, we investigated the role of IFN beta in differentiation and functional properties of monocytes and monocyte-derived dendritic cells that are critical to the inflammatory process in MS. The results revealed that IFN beta inhibited intracellular production of interleukin (IL)-1b (P<0.01) in both monocytes exposed to in vitro treatment of IFN beta and monocytes analysed ex vivo from MS patients treated with IFN beta. IFN beta was shown to modulate differentiation of monocytes into dendritic cells in the presence of IL-4 and GM-CSF, which resulted in a delayed differentiation process. Furthermore, it characteristically altered the phenotypic features of differentiated dendritic cells by inhibiting the expression of CD1a, CD11b, CD11c, CD123 and CD209 while upregulating costimulatory molecules, such as CD86. The selective regulatory properties of IFN beta appeared to render the function of differentiated dendritic cells to produce an increased amount (P<0.01) while their ability to secrete proinflammatory IL-12 and TGF beta was significantly reduced. The observed collective effects of IFN beta seemed to correlate with Th2 immune deviation. The study has provided new insights into the regulatory mechanisms of IFN beta in the treatment of MS.

Adjuvants, Immunologic↗

PubMed2004

Genetic analysis of SLC11A1 polymorphisms in multiple sclerosis patients.

Solute carrier 11a1 (SLC11A1; formerly NRAMP1, where NRAMP stands for natural resistance-associated macrophage protein) is a proton/bivalent cation antiporter that localizes to late endosomes/lysosomes. SLC11A1 regulates macrophage functions that are of potential importance in the induction and/or maintenance of autoimmune diseases such as rheumatoid arthritis, type I diabetes and Crohn's disease. We investigated SLC11A1 gene as a candidate gene for genetic susceptibility to multiple sclerosis (MS) in our population. Four SLC11A1 gene polymorphisms (5'GT repeat, D543N, 1729 + 55del4 and 1729 + 271del4) were analysed in a case-control study of 195 patients with MS and 125 control subjects. We found no evidence of association between SLC11A1 polymorphisms and MS susceptibility in the Spanish population.

Adult↗

PubMed2004

Cognitive strategies application of multiple sclerosis patients.

When performing a novel task, people need to generate and apply a working strategy. The application of an appropriate working strategy enables patients with cognitive impairment (CI) to perform tasks efficiently, which in turn makes it easier to meet the challenges of daily life tasks. We investigated the strategy application abilities (SAA) of multiple sclerosis (MS) patients and compared these results with data based on healthy subjects' performance. Seventy-six patients performed a Strategy Application Test (SAT) along with other cognitive tests, and completed depression, fatigue, and activity of daily living (ADL) questionnaires. Our results indicated that 76% of the MS patients included had impaired SAA, and that this impairment was not correlated with their depression, fatigue, Expanded Disability Severity Scale (EDSS), or ADL. These findings may have important implications for the understanding of the capability of MS patients to cope with nonroutine tasks, as well as for the potential of future implementation of cognitive rehabilitation in improving the SAA of patients with MS or other cognitive disorders.

Activities of Daily Living↗

PubMed2005

The Paced Auditory Serial Addition Test: to what extent is it performed as instructed, and is it associated with disease course?

One commonly used outcome measure in multiple sclerosis (MS) clinical trials is the Multiple Sclerosis Functional Composite, which includes the Paced Auditory Serial Addition Test (PASAT) as a measure of cognitive function. Concerns have been raised about the standard PASAT scoring method, whereby the number of correct responses is summed. This method does not take into account whether the test is performed as intended, which may affect interpretation of the results. Accordingly, another scoring method has been proposed, which examines the number of times a correct response is immediately preceded by another correct response (termed a dyad). We compared the two scoring methods for the PASAT, and found that the mean percentage of correct responses not accounted for by dyads ranged from 27.5% to 49.5%, indicating that much of the time the test is not performed as instructed. We also examined disease course and the PASAT score, as studies have produced conflicting results as to whether disease course is associated with cognitive impairment. Although disease course was significantly associated with the PASAT score, it accounted for little of the variation in scores, even when adjusting for other predictors. Finally, as 14.2% of participants refused to do the PASAT or failed to complete it, we also examined whether the Perceived Deficits Questionnaire (PDQ), a self-reported measure of cognitive function, is a potential proxy measure for the PASAT. The correlation between the two tools was low (-0.14), suggesting that the PDQ is not a useful substitute for the PASAT.

Adult↗

PubMed2005

Altered cytokine responses to cognitive stress in multiple sclerosis patients with fatigue.

This study intended to examine if the immune response to a cognitive task as a variant of psychological stress in MS patients is distinct from healthy controls. The experiment was part of a larger study on mechanisms and measurements of MS fatigue. Patients (n =23) and controls (n =25) participated in a cognitive task lasting 40 minutes, in which the heart rate was continuously monitored. Blood samples were taken at baseline and directly after the stress-inducing task Whole blood stimulated cytokine production representative of the TH-1 (i.e. IFNgamma, TNFalpha) and TH-2 paradigm (i.e. IL-10) was evaluated in relation to disability, fatigue, cognitive deficit, and anxiety. Patients scored high on a disease specific fatigue score compared to controls, whereas baseline cytokine patterns did not differ between the groups. MS patients displayed a blunted response of IFNgamma (P =0.03) whereas TNFalpha and IL-10 responses did not change. Additionally MS patients showed a significantly lower heart rate increase after the task (P <0.001). Cognitive impairment was associated with a decreased heart rate reactivity (P =0.02) while depressive symptoms correlated with stronger IL-10 responses (P =0.05). Overall, cognitive stress induces IFNgamma production in healthy controls but not in MS patients with fatigue. Furthermore, a reduced cardiac response might indicate an autonomic dysfunction in this group of patients.

Adult↗

PubMed2005

Spiroergometric and spirometric parameters in patients with multiple sclerosis: are there any links between these parameters and fatigue, depression, neurological impairment, disability, handicap and quality of life in multiple sclerosis?

One-hundred and twelve patients with multiple sclerosis were selected as population-based sample and examined on impairment (Expanded Disability Status Scale), disability (Barthel Index), handicap (Environment Status Scale), the quality of life (Multiple Sclerosis Quality of Life), fatigue (Modified Fatigue Impact Scale), depression (Beck Depression Inventory Score), respiratory function (spirometric parameters on spirometry) and physical fitness (spiroergometric parameters on a bicycle ergometer). The aim of the study was to examine and analyse (descriptive statistics) spiroergometric and spirometric parameters in patients with multiple sclerosis. Firstly, we tested the hypothesis whether spiroergometric and spirometric parameters are decreased and whether there are any correlations between these parameters and measures of impairment, depression, disability, handicap and quality of life. Secondly, we tested the hypothesis whether there is any correlation between a possible deconditioning and fatigue, and between a possible respiratory dysfunction and fatigue in multiple sclerosis. It results from this study that many spiroergometric parameters in patients with multiple sclerosis are significantly lowered in comparison to the population norm. A link can be found between some spiroergometric parameters and neurological impairment, disability, handicap and quality of life. It is not possible to prove any correlation between spiroergometric parameters and depression. From the spirometric parameters, these are expiratory flows that are significantly lowered in MS patients. It is not possible to prove any correlation between spirometric parameters and fatigue, depression, neurological impairment, duration of the disease, disability, handicap and quality of life in multiple sclerosis.

Adult↗

PubMed2005

Effect of pulsed magnetic field therapy on the level of fatigue in patients with multiple sclerosis--a randomized controlled trial.

Twenty-five multiple sclerosis patients, taking part in a rehabilitation program, were randomly assigned to treatment with pulsed magnetic field therapy (PMFT) or to sham therapy in order to study the additional effect of PMFT as part of a multimodal neurological rehabilitation program on fatigue. Patients demographic and disease specific characteristics were recorded. Level of fatigue was measured by fatigue severity scale (FSS) at entrance and discharge and with a visual analog scale (VAS) immediate before and after a single treatment session. The 'Magnetic Cell Regeneration' system by Santerra was used for PMFT. A single treatment lasted 16 minutes twice daily over 3-4 weeks and consisted of relaxed lying on a PMF mattress. Sham intervention was conducted in an identical manner with the PMF-device off. Patients and statistics were blinded. Level of fatigue measured by FSS was high at entrance in both treatment group (TG) and control group (CG) (5.6 versus 5.5). Over time of rehabilitation fatigue was reduced by 18% in TG and 7% in CG which was statistically not significant. There was a statistically significant immediate effect of the single treatment session which 18% reduction of fatigue measured by VAS in TG versus 11% in CG. Because of a high 'placebo effect' of simple bed rest, a only small and short lasting additional effect of PMFT and high costs of a PMF-device, we cannot recommend PMFT as an additional feature of a multimodal neurological rehabilitation program in order to reduce fatigue level of MS-patients.

Adult↗

PubMed2005

Accuracy of two electronic pedometers for measuring steps taken under controlled conditions among ambulatory individuals with multiple sclerosis.

Pedometers are inexpensive and user-friendly devices that might be practical for measuring physical activity among individuals with multiple sclerosis (MS). This study involved an evaluation of the accuracy of two pedometers against actual steps taken under controlled laboratory conditions (five minute bouts of walking at five different treadmill speeds [41, 54, 67, 80, and 94 m x min(-1)]) among 23 individuals with MS who were ambulatory without an aide. Both pedometers exhibited good accuracy with the 67, 80, and 94 m x min(-1) speeds, but poor accuracy with the 41 and 54 m x min(-1) speeds. Those results support the quantification of physical activity using pedometers among those with MS who are ambulatory without an aide.

Adult↗

PubMed2005

Severity of chronic pain and its relationship to quality of life in multiple sclerosis.

INTRODUCTION: This study used reliable and validated instruments to compare pain severity in multiple sclerosis (MS) to that in other chronic painful conditions, and to examine relationships between chronic pain in MS and health-related quality of life (HRQOL). METHODS: Ninety-nine MS patients completed a self-administered survey comprised of the Medical Outcomes 36-Item Short-Form Health Survey, the Short-Form McGill Pain Questionnaire, and the Hospital Anxiety and Depression Scale. RESULTS: Pain severity was not different between MS patients with pain and rheumatoid arthritis (P = 0.77) or osteoarthritis (P = 0.98) patients. Chronic pain in MS was less often neurogenic than non-neurogenic, although severity of neurogenic pain was greater than that of non-neurogenic pain (P = 0.048). Chronic pain in MS was found to have no significant relationship to age, disease duration or disease course. Instead, we found that pain was correlated with aspects of HRQOL, particularly mental health (r = 0.44, P < 0.0001) versus physical functioning (r = 0.19, P > 0.05). Chronic pain was significantly related to anxiety and depression for females but not for males with MS. CONCLUSIONS: Chronic pain in MS is as severe as pain in arthritic conditions and is associated with reduced HRQOL. Thus, pain can be a significant symptom for MS patients and the need for treatment may be underestimated.

Adult↗

PubMed2005

Trigeminal involvement in multiple sclerosis: magnetic resonance imaging findings with clinical correlation in a series of patients.

Trigeminal involvement detected by magnetic resonance imaging (MRI) in multiple sclerosis (MS) patients is usually associated with trigeminal neuralgia (TN) or painless paraesthesia in the trigeminal distribution. Our aim is to review the incidence of trigeminal involvement on MRI in a series of patients with MS at our institution, with further clinical correlation. We reviewed MRI scans of 275 MS patients for the presence of gadolinium enhancement on postcontrast T1-weighted images, anatomical and signal abnormalities on different sequences at the pontine trigeminal root entry zone (REZ) and in the cisternal portion of the nerves. We observed enhancement in the cisternal portion of the nerves and signal abnormalities (with or without enhancement) at the pontine trigeminal REZ in 8 (2.9%) patients, and enhancement was bilateral in 6 (75%) of those. Despite the inflammatory activity, none of them had TN and 3 (37.5%) had only painless paraesthesias in the correspondent V3 distribution. We also found a marked trigeminal hypertrophy in 2 (25%) patients, both with a longer period of disease. Our results confirm a high and clinically silent incidence of trigeminal involvement in MS patients, and suggest a simultaneous role of the central and peripheral type of myelin in trigeminal demyelination.

Adult↗

PubMed2005

Randomized controlled trial of an energy conservation course for persons with multiple sclerosis.

OBJECTIVE: To assess the short-term efficacy and effectiveness of a six-week energy conservation course on fatigue impact, quality of life and self-efficacy for persons with multiple sclerosis (MS). METHODS: In this randomized controlled trial, we randomly assigned 169 persons with MS to an immediate intervention group or a delayed control group using a crossover design. The outcome measures: Fatigue Impact Scale, SF-36 Health Survey and Self-Efficacy for Performing Energy Conservation Strategies were measured before and after courses and no intervention control periods. We performed intent-to-treat analysis and compliers-only analyses using mixed effects analysis of variance models. RESULTS: Taking the energy conservation course had significant effects on reducing the physical and social subscales of Fatigue Impact Scale and on increasing the Vitality subscale of the SF-36 scores compared with not taking the course. Additional subscales were significant depending on methods of analyses. Self-Efficacy for Performing Energy Conservation Strategies Assessment increased significantly (P <0.05) postcourse compared to precourse. CONCLUSIONS: Results support the efficacy and effectiveness of the energy conservation course to decrease fatigue impact, and to increase self-efficacy and some aspects of quality of life.

Adult↗

PubMed2005

Relapse rates and enhancing lesions in a phase II trial of natalizumab in multiple sclerosis.

BACKGROUND: Natalizumab, a humanized monoclonal IgG4 antibody, is an alpha4-integrin antagonist, which inhibits the migration of inflammatory cells into the central nervous system, a key pathogenic mechanism in multiple sclerosis (MS). In a six month, phase II clinical trial of patients with relapsing MS, natalizumab significantly reduced the formation of new gadolinium-enhanced (Gd+) lesions and the number of clinical relapses. OBJECTIVE: To investigate the relationship of historical relapse rate and new Gd + lesion number with subsequent MS disease activity and natalizumab treatment in the phase II study. METHODS: Patients who participated in the phase II study were stratified into subgroups according to: (i) the number of relapses in the two years prior to entry into the study: 2 relapses (n = 108), 3 relapses (n =57), and >3 relapses (n =48); (ii) the number of new Gd + lesions at baseline (Month 0): 0 (n = 129), 1-2 (n =50), and >2 (n =33). Relapses and new Gd + lesions during the treatment phase of the trial were determined and compared for each subgroup. RESULTS: Both the prestudy relapse rate and number of new Gd + lesions at baseline were related to the subsequent risk of a relapse; baseline number of Gd + lesions was related to the likelihood of subsequent new Gd + lesion formation. There was a lower proportion of subjects with an on-study relapse and fewer new Gd + lesions in all natalizumab-treated subgroups when compared with their placebo counterpart; the difference was most apparent in the subgroups of patients with >3 relapses in the two years prior to study entry and >2 new Gd -- lesions at Month 0. CONCLUSIONS: There was a lower proportion of subjects with an on-study relapse in natalizumab-treated patients, particularly in those with a more active disease at study entry. Larger ongoing phase III studies will allow more definitive investigation of these preliminary subgroup findings.

Adult↗

PubMed2005

Measuring quality of life in multiple sclerosis: not as simple as it sounds.

Data from a clinical study presented an opportunity to examine the psychometric properties of the Leeds Multiple Sclerosis Quality of Life scale (LMSQoL), which has undergone limited psychometric evaluation. LMSQoL and Multiple Sclerosis Quality of Life-54 (MSQoL-54) data were collected from 90 people with multiple sclerosis (MS) living in the community. Standard psychometric methods to examine data quality, scaling assumptions, scale to sample targeting, reliability, validity, and responsiveness were employed. The LMSQoL satisfied criteria for data quality (no missing data), scaling assumptions (item-total correlations: 0.24-0.56), reliability (Cronbach's alpha: 0.71), and demonstrated responsiveness (effect size: 0.34). Correlations between the LMSQoL and MSQoL-54 physical (range: -0.02 to -0.50) and emotional subscales (range: -0.38 to -0.65) were similar; the magnitude and pattern was not consistent with predictions based on the construct purported to be measured by the LMSQoL. The LMSQoL satisfied many psychometric criteria in this small study, however, it was difficult to interpret the validity data. From this, two fundamental measurement issues are highlighted. Firstly, current methods of examining rating scales provide only circumstantial evidence of validity; secondly, health-rating scales should be developed on the basis of clear conceptual definitions.

Adult↗

PubMed2006

Interferon treatment may trigger primary headaches in multiple sclerosis patients.

Recent data have suggested that interferon-beta (IFN-beta) may aggravate headaches in multiple sclerosis (MS) patients. The aim of this study was to investigate the life-time prevalence of primary headaches in MS patients treated with interferons in comparison with patients treated with other disease-modifying agents. Attention was focused on the onset of headache and the changes in pre-existing headaches in relation to the onset of therapy. The study was open-labelled and not randomized. We studied 150 consecutive MS patients treated with IFN-beta (109 patients: 54 with 1b, 55 with 1a) and with other drugs (41 patients: 14 with glatiramer acetate, 27 with azathioprine). All patients underwent a semi-structured interview to diagnose headache type, according to the International Headache Society criteria. The frequency of primary headaches was higher in the interferon-group (72%) compared to patients in the other group (54%) (P=0.03). Worsening of pre-existing headaches or development of de novo headache occurred only in the interferon-group (41 and 48%, respectively) and not in the other group (P<0.001). These results show that headache should be considered among the side-effects of interferon in MS patients.

Adjuvants, Immunologic↗

PubMed2006

Cognitive and motor function in people with multiple sclerosis in Stockholm County.

The aim of this study was to analyse cognitive and motor function in a population-based sample of people with multiple sclerosis (PwMS), taking into account both disease-related data and sociodemographic factors. Data were collected from 166 PwMS during home visits. Cognitive function was assessed by the Mini-Mental State Examination (MMSE), the Free Recall and Recognition of 12 Random Words Test (FRR12RWT), and the Symbol Digit Modalities Test (SDMT); manual dexterity by the Nine-Hole Peg Test (NHPT); global motor capacity by the Lindmark Motor Capacity Assessment; and walking capacity by a timed 10-metre walk. On cognitive tests, 55% (MMSE), 84% (FRR12RWT), and 45% (SDMT) of PwMS scored within the normal range; 27% of PwMS displayed normal manual dexterity, 9% had a maximal motorcapacity score, and 8% walked at normal speed. Factors associated with normal cognitive function were lower disability and higher education; lower disability and current employment were predictive of capacity to perform the NHPT and to walk 10 metres. In conclusion, cognitive function was normal in approximately half of the PwMS investigated, while a minority displayed normal manual dexterity and normal walking capacity. Thus, both disease severity and sociodemographic factors appear to influence cognitive and motor function in MS.

Activities of Daily Living↗

PubMed2006

Levocarnitine administration in multiple sclerosis patients with immunosuppressive therapy-induced fatigue.

Nutritional factors and comedications are among the postulated causes of fatigue, a highly prevalent symptom in the multiple sclerosis (MS) population, with serious impact on patients' quality of life. Deficiency of carnitine may play a role by reducing energy production through fatty acid oxidation and numerous MS therapies can induce fatigue syndrome. The aim of this prospective open-labelled study was to collect and study serum carnitine levels in MS patients with and without disease-modifying treatment-induced fatigue syndrome. We investigated whether restoration of the carnitine pool might improve treatment-induced fatigue in MS patients. In our study, there was no statistical difference in fatigue frequency between treated and untreated patients (P=0.5). Matched to age, gender and treatments, carnitine levels were lower for MS treated patients compared to untreated MS patients (P <0.05) or controls (P <0.001). Consecutive patients with low plasma carnitine levels who experienced fatigue were substituted. Treatment consisted of oral levocarnitine, 3-6 g daily. All patients achieved normal plasma carnitine levels. For 63% of patients treated with immunosuppressive or immunomodulatory therapies, oral levocarnitine adjunction decreased fatigue intensity, especially in patients treated with cyclophosphamide and interferon beta.

Acetylcarnitine↗