Hostname: page-component-586b7cd67f-t8hqh Total loading time: 0 Render date: 2024-11-22T05:36:27.008Z Has data issue: false hasContentIssue false
  • English
  • Français

Randomized Trials and Collaborative Research in Epilepsy Surgery: Future Directions

Published online by Cambridge University Press:  02 December 2014

Samuel Wiebe  and
Nathalie Jette
Samuel Wiebe*
Affiliation:
Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada
Nathalie Jette
Affiliation:
Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada
*
Foothills Medical Centre, 1403-29th Street N.W., Calgary, Alberta, T2N 2T9, Canada
Rights & Permissions [Opens in a new window]

Abstract

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.
Background:

Although randomized controlled trials (RCTs) are the gold standard for evaluating therapeutic interventions, surgical RCTs are particularly challenging and few have been done in the field of epilepsy surgery. We assess the level of RCT activity in epilepsy surgery and propose feasible alternatives to develop sustainable research initiatives in this area.

Methods:

We undertook a systematic review of the world literature to assess the level of RCT activity in epilepsy surgery. Previous personal experience with RCTs in epilepsy surgery and examples of successful Canadian multicentre research networks were reviewed to propose initiatives for sustainable, valid research in epilepsy surgery.

Results:

We identified 12 RCTs in epilepsy surgery, including 692 patients, of whom 416 were involved in vagus nerve stimulation, 16 in various brain electrostimulation procedures, 180 in comparisons of different surgical techniques, and 80 in a comparison of medical versus surgical therapy. Most studies were of short duration (median = 3 months, range 3-12 months). In the area of resective surgery, only temporal lobe epilepsy has been subjected to any type of RCT comparison. All RCTs have been done within the last 13 years. There were no multicentre Canadian surgical studies.

Conclusion:

The adoption of RCTs in epilepsy surgery has been slow and difficult worldwide. Because of its universal health care system and its well established epilepsy surgery centres, Canada is in a strong position to create a national epilepsy surgery research initiative capable of undertaking high quality, sustainable research in epilepsy surgery.

Résumé:

RÉSUMÉ: Contexte:

Bien que les essais contrôlés randomisés (ECRs) soient l’étalon or pour évaluer l’intervention thérapeutique, les ECRs chirurgicaux posent un défi particulier et peu ont été faits dans le domaine de la chirurgie de l’épilepsie. Nous avons évalué le niveau d’activité ECR en chirurgie de l’épilepsie et nous proposons des alternatives réalisables pour développer des initiatives de recherche viables dans ce domaine.

Méthodes:

Nous avons effectué une revue systématique de la littérature mondiale afin d’évaluer le niveau d’activité ECR en chirurgie de l’épilepsie. Nous avons revu notre expérience personnelle antérieure dans ce domaine et des exemples de recherche multicentrique en réseau au Canada qui ont été couronnées de succès afin de proposer des initiatives viables et valides dans ce domaine.

Résultats:

Nous avons identifié 12 ECRs en chirurgie de l’épilepsie auxquelles 692 patients ont participé, soit 416 patients qui ont participé à des études sur la stimulation du nerf vague, 16 à des études sur l’électrostimulation cérébrale par différentes techniques, 180 à des études de comparaison de différentes techniques chirurgicales et 80 à des études comparant un traitement médical à un traitement chirurgical. La plupart des études étaient de courte durée (médiane de 3 mois, fourchette de 3 à 12 mois). En ce qui concerne la résection chirurgicale, seule la chirurgie pour épilepsie temporale a fait l’objet d’ECRs. Tous les ECRs ont été faits au cours des 13 dernières années. Il n’existe pas d’étude chirurgicale canadienne multicentrique.

Conclusions:

Le recours aux ECRs dans le domaine de la chirurgie de l’épilepsie à travers le monde est un processus lent et difficile. Le Canada est dans une position privilégiée pour créer une initiative de recherche nationale dans ce domaine. Il possède un système universel de soins de santé et des centres de chirurgie de l’épilepsie qui sont bien établis, ce qui permet d’entreprendre une recherche viable, de haute qualité.

Type
Original Articles
Information
Canadian Journal of Neurological Sciences , Volume 33 , Issue 4 , November 2006 , pp. 365 - 371
Copyright
Copyright © The Canadian Journal of Neurological 2006

References

1. Schulz, KF, Chalmers, I, Hayes, RJ, Altman, DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995; 273: 408–12.Google Scholar
2. Brown, S, Thorpe, H, Hawkins, K, Brown, J. Minimization--reducing predictability for multi-centre trials whilst retaining balance within centre. Stat Med. 2005; 24: 3715–27.Google Scholar
3. Engel, J Jr., Wiebe, S, French, J, Sperling, M, Williamson, P, Spencer, D, et al. Practice parameter: temporal lobe and localized neocortical resections for epilepsy: report of the Quality Standards Subcommittee of the American Academy of Neurology, in Association with the American Epilepsy Society and the American Association of Neurological Surgeons. Neurology. 2003; 60: 538–47.Google Scholar
4. Wiebe, S. Randomized controlled trials of epilepsy surgery. Epilepsia. 2003; 44 Suppl 7:38–43.Google Scholar
5. Freed, CR, Greene, PE, Breeze, RE, Tsai, WY, DuMouchel, W, Kao, R, et al. Transplantation of embryonic dopamine neurons for severe Parkinson’s disease. N Engl J Med. 2001; 344: 710–9.CrossRefGoogle ScholarPubMed
6. Dekkers, W, Boer, G. Sham neurosurgery in patients with Parkinson’s disease: is it morally acceptable? J Med Ethics. 2001; 27: 151–6.Google Scholar
7. Dasheiff, RM, Ryan, CW, Lave, JR. Epilepsy brain surgery: a Pittsburgh perspective. Seizure. 1994; 3: 197–207.Google Scholar
8. Ommaya, AK. Behaviour after temporal lobectomy. J Neurol Neurosurg Psychiatry. 1963; 26: 556(Abstract)Google Scholar
9. Kuzniecky, R, Rubin, ZK, Faught, E, Morawetz, R. Antiepileptic drug treatment after temporal lobe epilepsy surgery: a randomized study comparing carbamazepine and polytherapy. Epilepsia. 1992; 33(5): 908–12.Google Scholar
10. Sahjpaul, RL, Mahon, J, Wiebe, S. Dexamethasone for morbidity after subdural electrode insertion--a randomized controlled trial. Can J Neurol Sci. 2003; 30: 340–8.Google Scholar
11. Amar, AP, Heck, CN, Levy, ML, Smith, T, DeGiorgio, CM, Oviedo, S, et al. An institutional experience with cervical vagus nerve trunk stimulation for medically refractory epilepsy: rationale, technique, and outcome. Neurosurgery. 1998; 43: 1265–76.Google Scholar
12. Scherrmann, J, Hoppe, C, Kral, T, Schramm, J, Elger, CE. Vagus nerve stimulation: clinical experience in a large patient series. J Clin Neurophysiol. 2001; 18: 408–14.CrossRefGoogle Scholar
13. Handforth, A, DeGiorgio, CM, Schachter, SC, Uthman, BM, Naritoku, DK, Tecoma, ES, et al. Vagus nerve stimulation therapy for partial-onset seizures: a randomized active-control trial. Neurology. 1998; 51: 48–55.Google Scholar
14. A randomized controlled trial of chronic vagus nerve stimulation for treatment of medically intractable seizures. The Vagus Nerve Stimulation Study Group. Neurology. 1995; 45: 224–30.CrossRefGoogle Scholar
15. Richards, TA. Surgery for temporal lobe epilepsy. Letter to the editor. N Engl J Med. 2002; 346: 293(Abstract)Google Scholar
16. DeGiorgio, C, Heck, C, Bunch, S, Britton, J, Green, P, Lancman, M, et al. Vagus nerve stimulation for epilepsy: randomized comparison of three stimulation paradigms. Neurology. 2005; 65: 317–9.Google Scholar
17. The Vagus Nerve Stimulation Study Group. A randomized controlled trial of chronic vagus nerve stimulation for treatment of medically intractable seizures. Neurology. 1995; 45: 224–30.Google Scholar
18. Fisher, RS, Uematsu, S, Krauss, GL, Cysyk, BJ, McPherson, R, Lesser, RP, et al. Placebo-controlled pilot study of centromedian thalamic stimulation in treatment of intractable seizures. Epilepsia. 1992; 33: 841–51.Google Scholar
19. Velasco, F, Carrillo-Ruiz, JD, Brito, F, Velasco, M, Velasco, AL, Marquez, I, et al. Double-blind, randomized controlled pilot study of bilateral cerebellar stimulation for treatment of intractable motor seizures. Epilepsia. 2005; 46: 1071–81.Google Scholar
20. Tellez-Zenteno, JF, McLachlan, RS, Parrent, A, Kubu, CS, Wiebe, S. Hippocampal electrical stimulation in mesial temporal lobe epilepsy. Neurology. 2006; 66:(Abstract)Google Scholar
21. Wyler, AR, Hermann, BP, Somes, G. Extent of medial temporal resection on outcome from anterior temporal lobectomy: a randomized prospective study. Neurosurgery. 1995; 37: 982–90.Google Scholar
22. Hermann, B, Davies, K, Foley, K, Bell, B. Visual confrontation naming outcome after standard left anterior temporal lobectomy with sparing versus resection of the superior temporal gyrus: a randomized prospective clinical trial. Epilepsia. 1999; 40: 1070–6.Google Scholar
23. Lutz, MT, Clusmann, H, Elger, CE, Schramm, J, Helmstaedter, C. Neuropsychological outcome after selective amygdalo-hippocampectomy with transsylvian versus transcortical approach: a randomized prospective clinical trial of surgery for temporal lobe epilepsy. Epilepsia. 2004; 45: 809–16.Google Scholar
24. Wiebe, S, Blume, WT, Girvin, JP, Eliasziw, M. A randomized, controlled trial of surgery for temporal-lobe epilepsy. N Engl J Med. 2001; 345: 311–8.Google Scholar
25. Engel, J Jr. The timing of surgical intervention for mesial temporal lobe epilepsy: a plan for a randomized clinical trial. Arch Neurol. 1999; 56: 1338–41.Google Scholar
26. Spencer, SS, Berg, AT, Vickrey, BG, Sperling, MR, Bazil, CW, Shinnar, S, et al. Initial outcomes in the Multicenter Study of Epilepsy Surgery. Neurology. 2003; 61: 1680–5.CrossRefGoogle ScholarPubMed
27. Spencer, SS, Berg, AT, Vickrey, BG, Sperling, MR, Bazil, CW, Shinnar, S, et al. Predicting long-term seizure outcome after resective epilepsy surgery: the multicenter study. Neurology. 2005; 65: 912–8.Google Scholar
28. Berg, AT, Langfitt, J, Shinnar, S, Vickray, BG, Sperling, MR, Walczak, T, et al. How long does it take for partial epilepsy to become intractable? Neurology. 2003; 60: 186–90.Google Scholar
29. Cook, D, Brower, R, Cooper, J, Brochard, L, Vincent, JL. Multicenter clinical research in adult critical care. Crit Care Med. 2002; 30: 1636–43.CrossRefGoogle ScholarPubMed
30. Cook, D, Heyland, D, Griffith, L, Cook, R, Marshall, J, Pagliarello, J. Risk factors for clinically important upper gastrointestinal bleeding in patients requiring mechanical ventilation. Canadian Critical Care Trials Group. Crit Care Med. 1999; 27: 2812–7.Google Scholar
31. Foster, D, Cook, D, Granton, J, Steinberg, M, Marshall, J. Use of a screen log to audit patient recruitment into multiple randomized trials in the intensive care unit. Canadian Critical Care Trials Group. Crit Care Med. 2000; 28: 867–71.Google Scholar
32. Vella, K, Goldfrad, C, Rowan, K, Bion, J, Black, N. Use of consensus development to establish national research priorities in critical care. Br Med J. 2000; 320: 976–80.Google Scholar