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Emmanuelle Waubant - One of the best experts on this subject based on the ideXlab platform.
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treatment of Fatigue with methylphenidate modafinil and amantadine in multiple sclerosis triumphant ms study design for a pragmatic randomized double blind crossover clinical trial
Contemporary Clinical Trials, 2018Co-Authors: Bardia Nourbakhsh, Nisha Revirajan, Emmanuelle WaubantAbstract:BACKGROUND: Fatigue is the most common symptom of multiple sclerosis (MS). Amantadine, modafinil and amphetamine-like stimulants are commonly used in clinical practice for treatment of Fatigue; however, the evidence supporting their effectiveness is sparse and conflicting. OBJECTIVE: To describe the design of a trial study funded by Patient-Centered Outcome Research Institute (PCORI) that will compare the efficacy of commonly used Fatigue medications in patients with MS. DESIGN/METHODS: The study is a randomized, placebo-controlled, crossover, four-sequence, four-period, double-blind, multicenter trial of three commonly used medications for the treatment of MS-related Fatigue (amantadine, modafinil, methylphenidate) versus placebo in Fatigued subjects with MS. Adult patients with MS, with an Expanded Disability Status Scale of <7.0 are eligible to participate. Participants will be randomized to one of four predefined sequences of medication administration. Each sequence comprises four 6-week periods of treatment with one of the 3 study drugs or placebo, and three 2-week washout periods between medication periods. RESULTS: 136 participants will be randomized over two years in two academic centers in the United States starting in the Summer 2017. Complete enrollment is expected by early 2019. The primary outcome of the study is the modified Fatigue Impact Scale (MFIS) score while participants receive the maximally tolerated dose of each study medication (or placebo). Safety and tolerability of the medications and heterogeneity of treatment effect will also be assessed. CONCLUSIONS: Results of the proposed study will provide evidence-based and personalized treatment options for patients affected by MS-related Fatigue. Clinicaltrials.gov registration number: NCT03185065.
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treatment of Fatigue with methylphenidate modafinil and amantadine in multiple sclerosis triumphant ms study design for a pragmatic randomized double blind crossover clinical trial
Contemporary Clinical Trials, 2018Co-Authors: Bardia Nourbakhsh, Nisha Revirajan, Emmanuelle WaubantAbstract:BACKGROUND Fatigue is the most common symptom of multiple sclerosis (MS). Amantadine, modafinil and amphetamine-like stimulants are commonly used in clinical practice for treatment of Fatigue; however, the evidence supporting their effectiveness is sparse and conflicting. OBJECTIVE To describe the design of a trial study funded by Patient-Centered Outcome Research Institute (PCORI) that will compare the efficacy of commonly used Fatigue medications in patients with MS. DESIGN/METHODS The study is a randomized, placebo-controlled, crossover, four-sequence, four-period, double-blind, multicenter trial of three commonly used medications for the treatment of MS-related Fatigue (amantadine, modafinil, methylphenidate) versus placebo in Fatigued subjects with MS. Adult patients with MS, with an Expanded Disability Status Scale of <7.0 are eligible to participate. Participants will be randomized to one of four predefined sequences of medication administration. Each sequence comprises four 6-week periods of treatment with one of the 3 study drugs or placebo, and three 2-week washout periods between medication periods. RESULTS 136 participants will be randomized over two years in two academic centers in the United States starting in the Summer 2017. Complete enrollment is expected by early 2019. The primary outcome of the study is the modified Fatigue Impact Scale (MFIS) score while participants receive the maximally tolerated dose of each study medication (or placebo). Safety and tolerability of the medications and heterogeneity of treatment effect will also be assessed. CONCLUSIONS Results of the proposed study will provide evidence-based and personalized treatment options for patients affected by MS-related Fatigue. Clinicaltrials.gov registration number: NCT03185065.
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modafinil for Fatigue in ms a randomized placebo controlled double blind study
Neurology, 2005Co-Authors: Bruno Stankoff, Emmanuelle Waubant, Christian Confavreux, Gilles Edan, Marc Debouverie, Lucien Rumbach, Thibault Moreau, Jean Pelletier, Catherine Lubetzki, M ClanetAbstract:Objective: To assess whether modafinil, a wakefulness-promoting agent, is useful for Fatigue in patients with multiple sclerosis (MS). Methods: Patients with MS with stable disability, and a baseline score of 45 or more on the Modified Fatigue Impact Scale (MFIS), were eligible for the 5-week randomized, double-blind, placebo-controlled, parallel group study. The initial daily dose of modafinil was 200 mg for 1 week. Depending on tolerance, the dose was increased by 100 mg every week up to 400 mg/day and remained unchanged between day 21 and day 35. The primary outcome variable was the change of MFIS score at day 35. Results: A total of 115 patients with MS were enrolled in the study and in the intention to treat analysis. The mean MFIS score at baseline was 63 ± 9 in the placebo group and 63 ± 10 in the modafinil group. MFIS scores improved between day 0 and day 35 in both placebo-treated and modafinil-treated groups, but no significant difference was detected between the two groups. There was no major safety concern. Conclusions: There was no improvement of Fatigue in patients with multiple sclerosis treated with modafinil vs placebo according to the Modified Fatigue Impact Scale.
John D Fisk - One of the best experts on this subject based on the ideXlab platform.
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the development and validation of the unidimensional Fatigue Impact Scale u fis
Multiple Sclerosis Journal, 2009Co-Authors: David M Meads, John D Fisk, L C Doward, Stephen P Mckenna, James Twiss, B EckertAbstract:Background: The multidimensional assessment of Fatigue is complicated by the interrelation of its multiple causes and effects.Objective: The purpose of the research was to develop a unidimensional assessment of Fatigue (U-FIS).Methods: Data collected with the Fatigue Impact Scale (FIS) were subjected to Rasch analysis to identify potential problems with the Scale. Additional items for the U-FIS were generated from interviews with UK MS patients. The U-FIS was tested for face and content validity in patient interviews and included in a validation survey to determine dimensionality (Rasch model), reliability and validity.Results: The original FIS was not unidimensional when subScale items were combined. The modification of the FIS and addition of a number of items allowed the development of a 22-item unidimensional Scale (U-FIS) that was reliable (Cronbach Alpha = 0.96; test-retest = 0.86,) and valid given correlations with the Nottingham Health Profile and ability to distinguish between MS severity groups....
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construction and validation of a Fatigue Impact Scale for daily administration d fis
Quality of Life Research, 2002Co-Authors: John D Fisk, Susan E DobleAbstract:The Fatigue Impact Scale (FIS) was developed previously as a symptom-specific profile measure of health-related quality of the (HRQoL) for use in medical conditions in which Fatigue is a prominent chronic symptom. Thus, it was not developed to be a responsive measure of daily changes in Fatigue. This study describes the development and initial validation of an adaptation of the FIS for daily use. Items for the daily Fatigue Impact Scale (D-FIS) were selected from the pool of original FIS items through Rasch analyses of existing data. The reduced-item FIS was administered to a sample of 93 subjects with flu-like illness, 25 of whom were followed for a 21-day period. Rasch analyses were used to further reduce the Scale to a minimum number of items that represented a unidimensional measure of self-reported Fatigue Impact. This 8-item D-FIS demonstrated good relations to flu symptom ratings and to other general health ratings. It also proved to be a responsive measure of change in reported Fatigue Impact for subjects who were followed longitudinally. This initial validation study indicates that the D-FIS has considerable promise as a valid measure of the subjective daily experience of Fatigue.
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the Impact of Fatigue on patients with multiple sclerosis
Canadian Journal of Neurological Sciences, 1994Co-Authors: John D Fisk, Paul Ritvo, Amanda Pontefract, Catherine J Archibald, T J MurrayAbstract:Although Fatigue is recognized as a symptom of MS, there have been insufficient methods for evaluating this symptom. We administered the Fatigue Impact Scale to 85 MS patients and 20 hypertensive patients. Neurologic impairment, mental health, and general health status were also assessed. MS patients reported significantly higher Fatigue Impact than hypertensive patients. Most MS patients reported Fatigue as either their worst (14%), or one of their worst (55%) symptoms. Disease classification and neurologic impairment had little bearing on Fatigue Impact Scale scores in the MS sample. The best predictive models for mental health and general health status in the MS sample both included the Fatigue Impact Scale as a significant factor. This study demonstrates that: 1) Fatigue is a very prevalent and severe problem in MS, 2) Fatigue Impact cannot be predicted by clinical measures of neurologic impairment, 3) Fatigue has a significant effect on the mental health and general health status of MS patients.
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measuring the functional Impact of Fatigue initial validation of the Fatigue Impact Scale
Clinical Infectious Diseases, 1994Co-Authors: John D Fisk, Paul Ritvo, Lynn Ross, David Haase, Thomas J Marrie, Walter F SchlechAbstract:The Fatigue Impact Scale (FIS) was developed to improve our understanding of the effects of Fatigue on quality of life. The FIS examines patients' perceptions of the functional limitations that Fatigue has caused over the past month. FIS items reflect perceived Impact on cognitive, physical, and psychosocial functioning. This study compared 145 patients referred for investigation of chronic Fatigue (ChF) with 105 patients with multiple sclerosis (MS) and 34 patients with mild hypertension (HT). Internal consistency for the FIS and its three subScales was >.87 for all analyses. Fatigue Impact was highest for the ChF group although the MS group's reported Fatigue also exceeded that of the HT group
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Measuring the Functional Impact of Fatigue: Initial Validation of the Fatigue Impact Scale
Clinical Infectious Diseases, 1994Co-Authors: John D Fisk, Paul Ritvo, Lynn Ross, David Haase, Thomas J Marrie, Walter F SchlechAbstract:The Fatigue Impact Scale (FIS) was developed to improve our understanding of the effects of Fatigue on quality of life. The FIS examines patients' perceptions of the functional limitations that Fatigue has caused over the past month. FIS items reflect perceived Impact on cognitive, physical, and psychosocial functioning. This study compared 145 patients referred for investigation of chronic Fatigue (ChF) with 105 patients with multiple sclerosis (MS) and 34 patients with mild hypertension (HT). Internal consistency for the FIS and its three subScales was > .87 for all analyses. Fatigue Impact was highest for the ChF group although the MS group's reported Fatigue also exceeded that of the HT group. Discriminant function analysis correctly classified 80.0% of the ChF group and 78.1% of the MS group when these groups were compared. This initial validation study indicates that the FIS has considerable merit as a measure of patient's attribution of functional limitations to symptoms of Fatigue.
Sonia Maria Togeiro - One of the best experts on this subject based on the ideXlab platform.
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upper airway resistance syndrome patients have worse sleep quality compared to mild obstructive sleep apnea
PLOS ONE, 2016Co-Authors: Luciana B M De Godoy, Sergio Tufik, Luciana Palombini, Luciana Oliveira E Silva, Wilson Hoshino, Thais Guimaraes, Lia Bittencourt, Sonia Maria TogeiroAbstract:Purpose To compare sleep quality and sustained attention of patients with Upper Airway Resistance Syndrome (UARS), mild Obstructive Sleep Apnea (OSA) and normal individuals. Methods UARS criteria were presence of excessive daytime sleepiness (Epworth Sleepiness Scale—ESS—≥ 10) and/or Fatigue (Modified Fatigue Impact Scale—MFIS—≥ 38) associated to Apnea/hypopnea index (AHI) ≤ 5 and Respiratory Disturbance Index (RDI) > 5 events/hour of sleep or more than 30% of total sleep time with flow limitation. Mild OSA was considered if the presence of excessive daytime sleepiness (ESS ≥ 10) and/or Fatigue (MFIS ≥ 38) associated to AHI ≥ 5 and ≤ 15 events/hour. “Control group” criteria were AHI < 5 events/hour and RDI ≤ 5 events/hour and ESS ≤ 9, without any sleep, clinical, neurological or psychiatric disorder. 115 individuals (34 UARS and 47 mild OSA patients and 34 individuals in “control group”), adjusted for age, gender, body mass index (BMI) and schooling years, performed sleep questionnaires and sustained attention evaluation. Psychomotor Vigilance Task (PVT) was performed five times (each two hours) from 8 a.m. to 4 p.m. Results UARS patients had worse sleep quality (Functional Outcomes of Sleep Questionnaire—FOSQ—and Pittsburgh Sleep Quality Index—PSQI: p < 0.05) and more Fatigue than mild OSA patients (p = 0.003) and scored significantly higher in both Beck inventories than “control group” (p < 0.02). UARS patients had more lapses early in the morning (in time 1) compared to the results in the afternoon (time 5) than mild OSA (p = 0.02). Mild OSA patients had more lapses in times 2 than in time 5 compared to “control group” (p = 0.04). Conclusions UARS patients have a worse sleep quality, more Fatigue and a worse early morning sustained attention compared to mild OSA. These last had a worse sustained attention than controls.
Julia L Newton - One of the best experts on this subject based on the ideXlab platform.
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primary sjogrens syndrome is associated with impaired autonomic response to orthostasis and sympathetic failure
QJM: An International Journal of Medicine, 2012Co-Authors: Wanfai Ng, A J Stangroom, Adrian Davidson, Katharine Wilton, S. Mitchell, Julia L NewtonAbstract:Background: Symptoms in keeping with autonomic dysfunction are commonly described by primary Sjogrens syndrome patients (pSS); whether objective abnormalities of autonomic function occur is unclear. This study set out to explore dynamic cardiovascular autonomic responses in pSS and their relationship with symptoms and quality of life. Methods: Twenty-one people from the UK pSS registry, 21 community controls and 21 patients with the autoimmune liver disease primary biliary cirrhosis (PBC) (matched case-wise for age and sex) attended for assessment of autonomic responses to orthostasis and Valsalva manoeuvre (VM). pSS patients also completed EULAR Sjogrens Syndrome patient-reported index (ESSPRI), EULAR Sjogren’s syndrome disease activity index (ESSDAI), Fatigue Impact Scale and EURO-QOL 5-dimension (EQ-5D). Results: Compared with controls, pSS patients had significantly lower baseline systolic blood pressure (SBP) (114 ± 13 vs. 127 ± 20; P = 0.02), which dropped to a significantly lower value (98 ± 22 vs. 119 ± 24, P = 0.009). When area under the curve (AUC) was calculated for when the SBP was below baseline this was significantly greater in pSS compared to both control groups (pSS vs. control vs. PBC: 153 ± 236 vs. 92 ± 85 vs. 1.2 ± 0.3, P = 0.005). Peak phase IV SBP during the VM was significantly lower in pSS (P = 0.007) indicating early sympathetic failure. Increased heart rate associated with Fatigue (P = 0.02; r2 = 0.2) and EQ-5D. A shift in sympathetic-vagal balance associated with overall symptom burden (ESSPRI) (P = 0.04, r2 = 0.3) and EULAR sicca score (P = 0.016; r2 = 0.3), the latter also correlated with baroreceptor effectiveness (P = 0.03; r2 = 0.2) and diastolic blood pressure variability (P = 0.003; r2 = 0.4). Conclusion: pSS patients have impaired blood pressure response to standing. Dysautonomia correlates with PSS-associated symptoms and quality of life.
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Fatigue in non alcoholic fatty liver disease nafld is significant and associates with inactivity and excessive daytime sleepiness but not with liver disease severity or insulin resistance
Gut, 2008Co-Authors: Julia L Newton, Katharine Wilton, David Jones, E Henderson, Lara Kane, A D BurtAbstract:Objective: To quantify Fatigue in NAFLD, to determine whether perceived Fatigue reflects impairment of physical function and to explore potential causes. Design: Cohort study. Setting: Regional Liver Unit /Teaching Hospital. Patients: 156 consecutive patients with histologically proven NAFLD studied in 2 cohorts. Main outcome measures: Phase 1: Perceived Fatigue experienced by NAFLD patients (assessed using the Fatigue Impact Scale (FIS)) in comparison to normal and liver disease controls, and relationship physical function (Actigraphy). Phase 2: Biological associations of Fatigue in NAFLD were explored. Results: Fatigue was markedly higher in NAFLD patients than in controls (mean FIS 51 ± 38 v 8 ± 12, p Conclusion: Fatigue is a significant problem in NAFLD, is similar in degree to that in PBC patients and reflects a true impairment in physical function. Fatigue in NAFLD appears to be unrelated to either severity of underlying liver disease or insulin resistance but is associated with significant daytime somnolence.
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Fatigue in primary biliary cirrhosis is associated with excessive daytime somnolence
Hepatology, 2006Co-Authors: Julia L Newton, John G Gibson, Katharine Wilton, Mark Tomlinson, David JonesAbstract:A significant proportion of patients with primary biliary cirrhosis (PBC) suffer from severe Fatigue. The aim of this study was to characterize patterns of daytime sleep in patients with PBC (using both objective and subjective assessment approaches) and to study the association between sleep abnormality and Fatigue severity. Fatigue severity was assessed in 48 female subjects with PBC (using a disease-specific quality of life instrument (the PBC-40) and a generic Fatigue measure (Fatigue Impact Scale [FIS]) as well as 48 case-matched normal controls. All participants also completed the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS, which assesses daytime hypersomnolence). Objective sleep assessment was performed using accelerometry over 7 days. Global sleep quality assessed by the PSQI was significantly lower in the PBC group compared to controls (P <.0001). ESS scores were significantly higher in patients with PBC than controls (P =.0001), suggesting significantly greater daytime somnolence in the patients with PBC. Objective sleep assessment confirmed that subjects with PBC were sleeping on average almost twice as long as controls during the daytime. Both degree of daytime somnolence (ESS) and actual daytime sleep activity (accelerometry) correlated strongly with Fatigue severity in the patient group (r2 = 0.5, P <.0001 and r2 = 0.2, P <.01, respectively). In conclusion, Sleep abnormality, in the form of excessive daytime somnolence, is present in a significant proportion of patients with PBC, with the degree of daytime somnolence correlating strongly with the degree of Fatigue. Existing agents effective at reducing daytime somnolence (such as modafinil) hold potential for the treatment of Fatigue in PBC. Supplementary material for this article can be found on the HEPATOLOGY website (http://interscience.wiley.com/jpages/0270-9139/supp-mat/index.html).
Richard A L Macdonell - One of the best experts on this subject based on the ideXlab platform.
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6. The Fampridine Upper Limb Study: Baseline clinical and electrophysiological data
Clinical Neurophysiology, 2016Co-Authors: Marion Simpson, Leeanne M. Carey, Belinda Bardsley, Con Yiannikas, Joanne Dimovitis, Elise Heriot, Richard A L MacdonellAbstract:Aim To describe initial clinical and electrophysiological results from the Fampridine Upper Limb Study, conducted in patients with Multiple Sclerosis (MS) and upper limb impairment. Methods This randomised, double-blinded placebo controlled trial of modified-release fampridine comprises three groups: patients on drug, patients on placebo and healthy controls. Baseline assessments conducted prior to initiation of drug (fampridine-MR 10 mg bd) or placebo included the following clinical tests: 9-hole peg test, manual grip strength, sensory discrimination capacity, visual acuity & contrast sensitivity, Fatigue Impact Scale score. Baseline electrophysiological tests included the following: visual evoked potential latency and amplitude, somatosensory evoked potential, median motor and sensory nerve conduction studies & F-waves, resting motor threshold, MEP latency, paired-pulse transcranial magnetic stimulation, MEP recruitment curves. Comparisons were made at baseline between MS patients and controls, and between patients with different MS subtypes (RRMS, PPMS, SPMS). Correlations were made between clinical and electrophysiological measures at baseline. Results 40 patients (60% female, median age 52 years) with MS and upper limb impairment and 20 healthy controls (60% female, median age 53 years) were studied. Of the patients, 9 had RRMS, 18 had SPMS and 13 had PPMS. The results of clinical measures of hand function (9-hole peg test, manual grip strength) and electrophysiological tests of nervous system function (VEP latency & amplitude, SSEP latency, MEP latency, resting motor threshold, MEP recruitment and PPTMS) are reported and compared between patients and controls and between patients with different subtypes of MS disease course. Conclusion Evoked potentials and TMS measures differ between MS patients and healthy controls, with observable differences between patients with different subtypes of MS. Such electrophysiological markers may represent useful surrogate markers in clinical trials of symptomatic and disease-modifying therapies for MS.
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49. : The fampridine upper limb study (FULS)
Journal of Clinical Neuroscience, 2014Co-Authors: Marion Simpson, Leeanne M. Carey, Belinda Bardsley, Con Yiannikas, Richard A L MacdonellAbstract:Modified-release 4-aminopyridine (fampridine) is licensed in Australia for the symptomatic treatment of walking disability in patients with multiple sclerosis (MS). Its potential for use in other neurological domains, its mode of action, and the reasons for widely variable responses in treated patients remain unknown. This study aims to test the following hypotheses: (1) modified-release fampridine is associated with improvements in upper limb impairment in patients with multiple sclerosis, and (2) objective electrophysiological measures differ between patients on and off treatment, and can potentially be used to differentiate clinical responders and non-responders. We conducted two substudies. Substudy 1 is a randomised, double-blind, placebo-controlled trial in patients with MS and upper limb impairment. Clinical and electrophysiological measurements are made at baseline, conclusion and on three occasions while participants are taking fampridine-modified release or placebo. Substudy 2 is a single-blind study in patients already taking fampridine for walking disability. Clinical and electrophysiological measurements are made in patients while on (twice) and off (once) the drug by a blinded assessor. Clinical measurements are nine-hole peg test, upper limb grip strength, sensory discrimination capacity, visual acuity and contrast sensitivity, and modified Fatigue Impact Scale. Electrophysiological measurements were resting motor threshold, motor evoked potential recruitment curves, short interstimulus intervals paired pulse transcranial magnetic stimulation (TMS), median nerve somatosensory evoked potentials, visual evoked potentials, and median nerve conduction study. The primary outcome measure is clinical response to fampridine as measured by performance on the nine-hole peg test. Secondary outcome measures are correlation between clinical and electrophysiological measures in responders as compared with non-responders, changes in upper limb grip strength, visual acuity and sensory discrimination capacity, and changes in modified Fatigue Impact Scale score. Our hypothesis is that clinical responders to fampridine will show increased motor pathway recruitment and cortical excitability with TMS measures, with improvements in latency and amplitude of evoked potential responses. This novel study seeks to determine whether fampridine can have beneficial effects in domains other than ambulation. By combining clinical and electrophysiological measures, we seek to better understand the mode of action of fampridine as a symptomatic therapy for MS and the reasons for the wide observed variation in clinical response.
