`
`June 5-9, 2002
`
`Chicagu, Illinuis
`
`Second Intermttt'uncr.l
`
`Mtrltfple Sclerosis l/Veele
`
`Multiple Scierctsis: A Wurld View
`
`ullipl-e sclterutsis is the must cnmmnn disnrcler af-
`leciing 1.InLI.n:g adults In the prime cut their tit-es.
`
`The netlr millennium brings a fresh perspective on it-t5
`care: El new vision ui -emgpn-1.I.r-erment
`2lt_'.|E patients and
`families and pnsitI.t'e apprnaciies re manage the dis-
`ease. its ssrmptnrrls. and its psttchnsntial implicatiuns.
`This net-.r trieur cul is-I5 care has spanrteci the uccans a.rn:i
`has resulted in the -i.'lE"|-|‘E'iE||Z|lTIE'l'Ii
`til ulcurldtlricle net-
`wnrlts at health care ptcwjclers in multiple sclerosis.
`T'l1e Cunsurtitim cut’ Multiple Sciernsis Centers. F'.|lt-is
`{Rehabililatiun in it.-lullipie Sclern-sis]. LACTRIM5
`{Latin Ptnterican tlnnttnittee nn ‘l'tean'nent and Re-
`
`search in Multiple E-clerusis]. ancl ltirlt-lfitl linternatiun—
`at flrgaiiizaliun c-E it-'[u|1ipie Sclerctsis hlursesj have set
`
`glclttal standards in MS care and research and have cal-
`laherated In nrganitte and ct:--spttnsnt this meeting.
`
`Multiple Eeternsis: .-‘L ‘titlczrriti View culiers an interna-
`tlunai trlcw un t:lIr1:I|:a|: arid research issues in multiple
`
`sclerusis. The cuppclrtunitg.-' tu tneet. cnnler and nel-.t-url:
`wills t:t:II|eagues lrnrn natinrts lI:tt:a'Ied Iltrnughuut the
`wnriti inalte this annual rneeting Line '_.-nu will tint want
`In miss. This is the Secnnti annual lnternatinnal Multi-
`
`ple Eclrrrnrsis 1.I.r-eel-'. ithe first taking place in Basel. in
`1999} leaturing an llttegratt-t:l research traclt. nttrrte-rmas
`wclrkshups. a I.'i-it-' tntailtr in Spanish let our Latin
`American delegates. satellite st-mpnsia, and an inter-
`
`national dalahases-‘registries meeting [lCDDlluiS].
`
`Cclnlerence ilighiights:
`Basic research and clinical trials
`
`tlcrllalsnrati-re international approaches in managing
`multiple sclerosis
`Gender issues in multiple sclerosis
`Tecttnculu-gical advances in clinical care amt research
`Metwnrking clppcurttlniiies
`Eatltilsits with the latest in services and pruciurts
`Evening events in IZ‘i':icagn's "it-iagniiicettl it-tile.‘
`
`I....a .'.-...-...-.-.I...-- ‘ ill.-"l|.Flll-'7'tl||"'-|'|'I||l|'Il'li:"«I.iliillN‘~ lfq'{I"i-i'H|
`
`LtItt:‘l'Fl'I|IE ill I'f"iIIIIIIIrI--II|.I'r
` Ell
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`T3
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`MYLAN PHARMS. INC. EXHIBIT 1049 PAGE 1
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`NONADHERENCE TO IMMUNMODULATION IN MULTIPLE SCLEROSIS
`
`Purpose: The primary objective of tl1is study is to outline factors leading to nonadherence or cessation of iminuninodulation therapy in a multiple sclerosis clinic pop-
`ulation. The secondary aim is to provide related recommendations to MS patients and nurse educators.
`
`Rationale: Nonadherence has been estimated at greater than 50%. Encouraging adherence to therapy is an integral pan of the MS nurse’s role. If only half of all pa-
`tients starting therapy will succeed, we need to learn more about factors relating to unsuccessful therapy attempts.
`Methods: A retrospective study of individuals attending a multiple sclerosis out-patient clinic (n = 1,000) will be conducted to identify patients who have received im-
`munmodulating therapy. In addition, patients who have ceased or changed therapy will be identified. Key factors relating to nonadherence will be categorized and
`outlined as they correspond to individual medications. Resulting implications for MS patients and nurse educators will be presented.
`Evelyn Vee McBride, RN, BScN, Kingston General Hospital, Kingston, Ontario, Canada
`
`EVALUATION OF A NEW SENSORISED UPPER LIMB TREMOR MEASUREMENT SYSTEM IN MS
`
`Developed under the EU programme TREMOR (DE3216) the system consists of linked movement sensors mounted on a lightweight frame. It measures angular di-
`rection, change, velocity and acceleration in 7 degrees of freedom (DOF) at the shoulder, elbow and wrist joints. It is the first system to simultaneously measure
`upper limb kinetic and intention tremor at all three joints and at full range of movement (ROM). Bespoke software allows the collection, storage, retrieval, and
`analysis of recorded signals. A graphic display enables the operator to see whole or part recordings and pinpoint the part of the movement trajectory where tremor
`occurs. Three movement tests were performed encompassing normal functional ROM the “finger to nose test", the “police, stop" test and the “OK” test. Reliabili-
`ty of the system was tested in 10 control subjects (mean age 45 years). Test-retest values for 10 control subjects showed, modest to good agreement for all move-
`ments and at all linkages. Movements at the wrist showed the poorest agreement. Level of tremor was measured in six MS patients [mean age 47 years, EDSS
`range 6.0 to 7.5). Subjects were clinically assessed using the Fahn tremor rating scale. Mean time taken to accurately perform each test was significantly longer in
`the patient group compared with the control group and longest in those with the greatest tremor (controls 7.6 i 1.9s MS subjects 12.4 1 6.2s). Recorded test time
`and frequency and amplitude of oscillations correlated well with the Fahn score. Whilst elements of the rig and linkage construction need to be improved these
`preliminary studies indicate that the evaluation of tremor at different angular velocities and limb positions is possible with this system. Such information will help
`to develop better therapeutic strategies.
`
`A. Davies Smith, R. Jones, (UK); P. Feys, G. Nuyens, P. Ketelaer (BE); A. Romberg (F); G. Gomes, G. Johnson, J. Cotterill (UK); and S. Scattareggia (IT):
`MS Research Unit, Bristol General Hospital, Bristol UK
`
`THE PSYCHOLOGICAL AND EMOTIONAL EFFECT OF A STRESS MANAGEMENT PROTOCOL
`ON PERSONS WITH MULTIPLE SCLEROSIS
`
`This study examined the effect of a behavioral stress management intervention, including relaxation and visualization components, on the psychological and emo-
`tional aspects of patients’ response to MS. Subjects were randomly divided into treatment and control groups, which upon completion of the study had 227 subjects
`and 150 subjects respectively. The treatment group participated in a one-day workshop where they learned systematic relaxation techniques and a visualization exer-
`cise specific to the effects of MS on the participant’s neural system and functioning. The treatment group was asked to practice these techniques on a regular sched-
`ule. Participation was monitored weekly via telephone contact or e-mail. Anxiety and depression were assessed using the State-Trait Personality Inventory (Spell-
`berger, Ritterband, Sydeman, Reheiser & Unger, in Butcher, 1995), Self Efficacy was assessed with the Multiple Sclerosis Self Efficacy (MSSE) scale (Schwartz,
`Coulthard-Morns, Zeng, & Retzlaff, 1996] and the Attnbutional Style Questionnaire (ASQ—Pete1son, et al, 1984). Pretesting of both groups was done immediately pn-
`or to the stress workshop and post-testing was 12 weeks later. Initial data analysis suggests self-efficacy is negatively correlated with depression and anxiety. Males
`tended to present themselves as more hostile than depressed and anxious.
`Joan B. Read, PhD, and G. Dean Ericson, PhD, MS Center at Shepherd, Atlanta, GA
`
`ACOUSTIC ANALYSIS :
`A PREDICTIVE INSTRUMENT FOR DIAGNOSIS AND CONTROL OF DYSARTI-IRIA IN MS
`
`Acoustic analysis provides an interface between speech production and perception and can be used to detect and document the progressive course of motor speech
`disorders and identify subclinical manifestations.
`
`Material and Method: All analyses are performed on the Computer Speech Lab (Model 43008) of Kay. Acoustic characteristics are identified in wide-
`band spectrograms, with frequency range from 0 to 50.000 Hz and time intervals of 3 sec. The linear predictive coding (LPC) method and the analysis of
`the variations of amplitude and fundamental frequency from cycle to cycle may detect symptoms such as phonatory instability and nazalisation. Addi-
`tional acoustic data are obtained through the Multidimensional Voice Profile and the Motor Speech Program. These programs analyze the intonation
`variations, the diadochokinetic rate, the voice tremor and second formant variations during speech productions. All subjects had to sustain the vowel
`/a/ for at least 5 sec., to repeat the syllabes /pa-ta-ka/ and /i-u/ as quickly as possible, and speak standard productions at “normal” rate without un-
`necessary pauses.
`
`Subjects: All subjects performed a perceptual screening of dysarthna (Frenchay — Enderby); 20 normal adult subjects are defined as non dysarthnc (10 males, 10 fe-
`males) and 20 individuals with MS (10 males, 10 females) present dysarthna (spastic, spastic ataxic) at different grades (moderate, mild, severe).
`
`Discussion: At this stage of the study, it seems that some acoustic parameters are sensitive to the fluctuations of voice and speech disorders in MS. Degree of voice-
`less, deviation of fundamental frequency, variations of amplitude, tremor, temporal deregulation (dysdiadochokinesy) and imprecise articulation could be considered
`as predictive parameters of specific voice and speech disorders in MS. Results of clinical cases will also be discussed.
`
`Guy Ganty, Speech Therapy Department, National MS Centre, Melsbroek, Belgium
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`MYLAN PHARMS. INC. EXHIBIT 1049 PAGE 2