Quality-of-Life Assessment in Patients Treated with Vagus Nerve Stimulation

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<ul><li><p>BRIEF COMMUNICATION</p><p>Qua tiewith</p><p>Erhanand JeDepartme915 Cami</p><p>Receivedaccepted</p><p>patieIE-10ry, leocialfore a</p><p>6 months, and 912 months after the initiation of VNS in 17 patients. QOLIE-10 scores were signifi-cantly better after the initiation of the therapy as compared with baseline (P &lt; 0.01). There was nocorrelation between the improvement in QOLIE-10 scores and the reduction in seizure frequency,</p><p>INTRO</p><p>Vagustherapyfocal-onshown tquencyepilepticfrequenwith epreceivement anperceivestudiestic treat</p><p>1 To wh6692. E-m</p><p>Epilepsy &amp; Behavior 2, 284287 (2001)</p><p>doi:10.1006/ebeh.2001.0173, available online at http://www.idealibrary.com ondecreased severity of seizures, or increased level of energy/alertness. We conclude that VNS therapyis associated with a significant improvement in subjective quality of life. 2001 Academic Press</p><p>Key Words: vagus nerve stimulation; quality of life; refractory epilepsy.</p><p>DUCTION</p><p>nerve stimulation (VNS) is a novel adjunctiveused in patients with medically intractable,</p><p>set epilepsy (13). Previous studies havehat VNS induces a reduction in seizure fre-comparable to that produced by major anti-drugs (1, 3). Besides the reduction in seizure</p><p>cy, an important consideration for patientsilepsy is the overall effect of treatments theyon the quality of their lives. Hence, the assess-d monitoring of changes in quality of life asd by patients have been part of many clinical</p><p>evaluating the effectiveness of new antiepilep-ments (4, 5).</p><p>The purpose of the present prospective study was toinvestigate if VNS therapy produced subjective im-provements in quality of life in patients with epilepsyrefractory to pharmacological treatments. Preliminaryresults from this study have been published in abstractform (6).</p><p>METHODS</p><p>Seventeen patients (6 female, 11 male) with partial-onset epilepsy were studied in a prospective fashion.The average patient age was 33.8 years (range, 1155years). All patients had persistent, frequent seizuresdespite appropriate medical management. They werenot candidates for surgical treatment either because ofa documented bilaterally independent onset of sei-zures from two hemispheres or because they were notinterested in surgical treatment. The etiologies of sei-</p><p>om correspondence should be addressed. Fax: (505) 272-ail: JShih@salud.unm.edu.</p><p>1525-5050/01 $35.00Copyright 2001 by Academic Presslity-of-Life Assessment in PaVagus Nerve Stimulation</p><p>Ergene, M.D., Pamela K. Behr, R.N.,rry J. Shih, M.D.1</p><p>nt of Neurology, University of New Mexico School of Medicine,no De Salud NE, Albuquerque, New Mexico 87131-5281</p><p>December 1, 2000; revised February 26, 2001;for publication March 5, 2001</p><p>Vagus nerve stimulation (VNS) is a novel therapy used inWe administered a Quality of Life in Epilepsy10 (QOLdesigned to assess the patients rating of their memoenergy, depression, worries about seizures and work, sVNS treatment. The questionnaire was administered be284nts Treated</p><p>nts with medically intractable epilepsy.) questionnaire consisting of questionsvel of physical and mental well-being,limitations, and overall quality of life onnd at 13 weeks, 57 weeks, 3 months,All rights of reproduction in any form reserved.</p></li><li><p>zures in study patients included cerebral palsy/peri-natal brain injury in 5 patients, mesial temporal scle-rosis in 3, traumatic brain injury in 2, subarachnoidhemorrhage due to aneurysm in 1, cavernous angio-mas in 1, and a history of meningitis during infancy in1. The cAll pati</p><p>Priortion of tto a quetory10tive quaal. (7), cpatientsphysicalworriesand ovenaire isreceivesthe ques</p><p>One tQOLIE-all patieimplant30-Hz son-timelation inually inriod, wi</p><p>Afteradminismonths,</p><p>In addwere asquency,followintions forcreased,effectstreatmendoses othrough</p><p>Totalthe initicomparesame pathe assescale scance (ANIn additan ANO</p><p>thoutrease</p><p>ed to</p><p>SUL</p><p>eanwer ter these atear dted in</p><p>t therted aile o</p><p>nts exardlet ofrtnesrized</p><p>tweenquenergy/n betwriableide e</p><p>itationathin</p><p>igastrin 1</p><p>. 1. ILIE-10le scorell time, 0.01</p><p>285Brief Communicationause of seizures was unknown in 4 patients.ents agreed to be treated with VNS.to implantation of the VNS device and initia-reatment, the patients were asked to respondstionnaire, Quality of Life in Epilepsy Inven-</p><p>(QOLIE-10), to assess their baseline subjec-lity of life. QOLIE-10, developed by Cramer etonsists of 10 questions designed to assess the subjective rating of their memory, level of</p><p>and mental well-being, energy, depression,about seizures and work, social limitations,rall quality of life. Each item in the question-ranked on a scale of 1 to 5, and the patienta total scale score of 10 to 50 by answering alltions.</p><p>o three weeks after the initial administration of10, a VNS device was surgically implanted innts. The device was turned on 2 weeks afteration. Standard stimulation parameters ofignal frequency, 500-ms pulse width, 30 s of, and 5 min of off-time were used. The stimu-tensity was initially set at 0.25 mA, and grad-creased to tolerance over a 2- to 3-month pe-th a final value of 1.0 to 2.5 mA in all patients.the baseline assessment, QOLIE-10 was againtered at 13 weeks, 57 weeks, 3 months, 6and 912 months after the initiation of VNS.ition, during each follow-up visit, the patients</p><p>ked if there were any changes in seizure fre-severity, and/or level of energy and alertnessg seizures. The answers to each of these ques-each patient were noted as increased, de-</p><p> or no change. The presence of any sideor subjective complaints attributable to the</p><p>t was also noted. All patients were on stablef two or three antiepileptic drugs (AEDs)out the study.QOLIE-10 score at each time point followingation of VNS treatment for each patient wasd with the baseline QOLIE-10 score of thetient prior to the initiation of treatment. Forssment of statistically significant changes in</p><p>ores across time, a one-way analysis of vari-OVA) for repeated measures was performed.</p><p>ion, QOLIE-10 scores were compared, usingVA of contrast variables, in patients with and</p><p>wiincus</p><p>RE</p><p>M(loafttho1-ytra</p><p>Apowhtieregcenalemabefreentiova</p><p>Sirrbreeping</p><p>FIGQOscaat a(Pdecreased seizure frequency, severity, andd level of energy. A two-tailed P value wasdetermine statistical significance.</p><p>TS</p><p>QOLIE-10 scores were significantly improvedotal QOLIE-10 scale scores) at all time points</p><p>initiation of VNS therapy as compared withbaseline (P , 0.01) throughout the study ofuration. These results are graphically illus-Fig. 1.6-month follow-up visit, 53% of patients re-notable decrease in their seizure frequency</p><p>n VNS treatment. In addition, 59% of pa-perienced a decrease in severity of seizuresss of change in frequency. Twenty-nine per-</p><p>patients felt an increased level of energy ands. Various effects of VNS therapy are sum-</p><p>in Table 1. An analysis of the interactionQOLIE-10 scores and the reduction in seizure</p><p>cy, seizure severity, and increased level ofalertness showed that there was no correla-</p><p>een the improved QOLIE-10 scores and theses.ffects from VNS were minimal, and included/spasm in throat in 4 patients, difficultyg in 1 patient, difficulty speaking in 1 patient,ic discomfort in 1 patient, and increased snor-patient.</p><p>mprovement in QOLIE-10 scores over time. Maximumscore is 50 (worst). ANOVA indicated that the mean totals were significantly better (lower QOLIE-10, total scores)points after the initiation of the therapy than baseline</p><p>). Bars: 6SEM.</p><p>Copyright 2001 by Academic PressAll rights of reproduction in any form reserved.</p></li><li><p>DISCU</p><p>The amedicalin previtherapypatientssults corbased oscale, hbeing inhave rep(8), andety in p</p><p>We rebrief offiwas notfor QOLaddressinstrumswer twprovemplantati</p><p>Based on our results, the answers are affirmative. Thesignificantly improved subjective quality of life in thepresent study may have been related to physiologicalchanges induced by VNS, minimal side effects fromthe treatment, or even the effect of having a device</p><p>plantprovein phlaceb</p><p>ect, thcantn gen</p><p>ilepsyencyality-ctingsitive</p><p>e perdesiranificady mvem</p><p>ggestmecherityn sumiated</p><p>subjedeter</p><p>KN</p><p>he auth the sInc., a</p><p>w Mex</p><p>FER</p><p>SchanervMorrStudstimu1999HandstimuactivLeidyqualithera</p><p>TABLE 1</p><p>Effects of VNS Therapy on Seizure Frequency, Severity,and Level of Energy/Alertness</p><p>PatientNo.</p><p>Decreasedseizure</p><p>Decreasedseizure</p><p>Increased levelof energy/</p><p>123456789</p><p>1011121314151617</p><p>Total n (%</p><p>a 1 andtively, basfollow-up</p><p>286 Ergene, Behr, and Shih</p><p>Copyright 2All rights of rSSION</p><p>nticonvulsant effect of VNS in patients withly intractable epilepsy has been documentedous studies (1, 2). Our results show that VNSmay also improve overall quality of life inwith medically refractory epilepsy. These re-roborate the results of a previous study that,n a single-question, subject-rated well-beingas shown an improved perception of well-</p><p>VNS patients (7). In addition, recent studiesorted that VNS enhances recognition memorydecreases symptoms of depression and anxi-</p><p>atients with epilepsy (9, 10).cognize this is an uncontrolled study using ace-based QOLIE-10 questionnaire. This studydesigned to determine the etiology or reasonsimprovement, nor does it have the power tomore specific QOL issues present in other</p><p>ents such as the QOLIE-89. We set out to an-o questions: Do patients experience an im-</p><p>ent in subjective quality of life after VNS im-on? Do QOL improvements persist over time?</p><p>imimbraa peffnifi</p><p>Iepququflesenfreunsigstuprosuasev</p><p>Isocinto</p><p>AC</p><p>Twitics,Ne</p><p>RE</p><p>1.</p><p>2.</p><p>3.</p><p>4.</p><p>frequency severity alertness</p><p>1a 2 12 1 22 2 22 1 21 1 11 1 21 1 22 1 22 2 21 2 11 2 21 1 11 1 21 2 22 1 12 1 22 2 2</p><p>) 9 (53%) 10 (59%) 5 (29%)</p><p>2 indicate the presence and absence of the effect, respec-ed on the subjective perception of each patient at 6-monthvisit.</p><p>001 by Academic Presseproduction in any form reserved.ed in the chest wall. Although we feel the QOLments are due to specific effects of VNS onysiology, we cannot exclude the possibility ofo effect. However, if we are seeing a placeboen this effect produces a persistent and sig-</p><p>positive change from baseline.eral, an improvement of QOL in patients with</p><p>correlates with reduction in seizure fre-(11). However, in studies using health-relatedof-life assessment instruments, subscales re-the psychological and social domains are most</p><p>to treatments designed to increase seizure-iods, reduce seizure severity, and minimizeble effects (3). QOL improvements were notntly correlated to seizure frequency in ourainly because several subjects had QOL im-</p><p>ents without a change in seizures. This wouldVNS may produce positive effects on QOL byanism independent of seizure frequency or.</p><p>mary, VNS implantation and therapy is as-with a persistent and positive improvement</p><p>ctive quality of life. Further studies are neededmine the underlying causes of this change.</p><p>OWLEDGMENTS</p><p>hors thank Clifford R. Qualls, Ph.D., for his assistancetatistical analysis. This study was supported by Cyberon-nd the General Clinical Research Center, University ofico School of Medicine.</p><p>ENCES</p><p>chter SC, Saper C. Progress in epilepsy research: vaguse stimulation. Epilepsia 1998;39:67786.is GL III, Mueller WM, and the Vagus Nerve Stimulationy Group E01-E05. Long-term treatment with vagus nervelation in patients with refractory epilepsy. Neurology</p><p>;53:17315.forth A, DeGiorgio CM, Schachter SC, et al. Vagus nervelation therapy for partial-onset seizures: a randomized</p><p>e-control trial. Neurology 1998;51:4855.NK, Rentz AM, Grace EM. Evaluating health-related</p><p>ty of life outcomes in clinical trials of antiepileptic drugpy. Epilepsia 1998;39:96577.</p></li><li><p>5. Baker GA, Camfield C, Camfield P, et al. Commission onoutcome measurement in epilepsy, 19941997: final report.Epilepsia 1998;39:21331.</p><p>6. Ergene E, Behr P, Shih JJ. Subjective quality of life improve-ment in patients treated with vagus nerve stimulation. Epilep-sia 1999;40(S7):2212.</p><p>7. Cramer JA, Perrine K, Devinsky O, Meador KJ. A brief ques-tionnaire to screen for quality of life in epilepsy: the QOLIE-10.Epilepsia 1996;37:57782.</p><p>8. Devinsky O. Clinical uses of the quality-of-life in epilepsyinventory. Epilepsia 1993;34(suppl 4):S3944.</p><p>9. Clark KB, Naritoku DK, Smith DC, Browning RA, Jensen RA.</p><p>Enhanced recognition memory following vagus nerve stimu-lation in human subjects. Nat Neurosci 1999;2:948.</p><p>10. Nikolov BG, Harden CL, Pick L, et al. Mood and anxietychanges in epilepsy patients treated with 3 different antisei-zure interventions. Epilepsia 1999;40(S7):58.</p><p>11. Leidy NK, Elixhauser A, Vickrey B, Means E, Willian MK.Seizure frequency and the health-related quality of life ofadults with epilepsy. Neurology 1999;53:1626.</p><p>12. Ettinger AB, Nolan E, Vitale S, Schindler RJ, Cramer J, Weis-brot DM. Changes in mood and quality of life in adult epilepsypatients treated with vagus nerve stimulation. Epilepsia 1999;40(S7):62.</p><p>287Brief CommunicationCopyright 2001 by Academic PressAll rights of reproduction in any form reserved.</p><p>INTRODUCTIONMETHODSFIG. 1</p><p>RESULTSTABLE 1</p><p>DISCUSSIONACKNOWLEDGMENTSREFERENCES</p></li></ul>

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