Efficacy of vision restoration therapy after optic neuritis (VISION study): Study protocol for a randomized controlled trial

Trials

Volumn 13, Issue , 2012, Pages

  Schinzel, Johann ^a   Schwarzlose, Lina ^a   Dietze, Holger ^b   Bartusch, Karolina ^a,b   Weiss, Susanne ^a,b   Ohlraun, Stephanie ^a   Paul, Friedemann ^a,c   Dörr, Jan ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b BEUTH UNIVERSITY OF APPLIED SCIENCES   (Germany)

^c MAX DELBRÜCK CENTER FOR MOLECULAR MEDICINE   (Germany)

Author keywords

Multiple sclerosis; Neuroplasticity; Optic neuritis; Treatment; Vision restoration therapy; Visual function

Indexed keywords

ARTICLE; BINOCULAR VISION; CONTROLLED STUDY; DEPRESSION; DOUBLE BLIND PROCEDURE; EVOKED VISUAL RESPONSE; EYE MOVEMENT; HUMAN; MAJOR CLINICAL STUDY; OPTIC NEURITIS; OPTICAL COHERENCE TOMOGRAPHY; PERIMETRY; PILOT STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; THERAPY; VISION RESTORATION TRAINING; VISUAL ACUITY; VISUAL FIELD; CLINICAL TRIAL; COMPUTER ASSISTED THERAPY; CONTRAST SENSITIVITY; CONTROLLED CLINICAL TRIAL; CONVALESCENCE; GERMANY; METHODOLOGY; PATHOPHYSIOLOGY; PATIENT SELECTION; PHOTOSTIMULATION; QUESTIONNAIRE; SCOTOMA; TIME; TREATMENT OUTCOME; VISION; VISION TEST; VISUAL DISORDER;

CONTRAST SENSITIVITY; DOUBLE-BLIND METHOD; EVOKED POTENTIALS, VISUAL; GERMANY; HUMANS; OPTIC NEURITIS; PATIENT SELECTION; PHOTIC STIMULATION; PILOT PROJECTS; QUALITY OF LIFE; QUESTIONNAIRES; RECOVERY OF FUNCTION; RESEARCH DESIGN; SCOTOMA; THERAPY, COMPUTER-ASSISTED; TIME FACTORS; TOMOGRAPHY, OPTICAL COHERENCE; TREATMENT OUTCOME; VISION DISORDERS; VISION TESTS; VISION, OCULAR; VISUAL ACUITY; VISUAL FIELDS;

EID: 84862771479     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-94     Document Type: Article

References (43)

1. Compston A, Coles A. Multiple sclerosis. Lancet 2008, 372:1502-1517. 10.1016/S0140-6736(08)61620-7, 18970977.
2. Wiendl H, Toyka KV, Rieckmann P, Gold R, Hartung H-P, Hohlfeld R, . Multiple Sclerosis Therapy Consensus Group (MSTCG) Basic and escalating immunomodulatory treatments in multiple sclerosis: current therapeutic recommendations. J Neurol 2008, 255:1449-1463. Multiple Sclerosis Therapy Consensus Group (MSTCG).
3. Balcer LJ. Optic neuritis. N Engl J Med 2006, 354:1273-1280. 10.1056/NEJMcp053247, 16554529.
4. Pirko I, Blauwet LA, Blauwet LK, Lesnick TG, Weinshenker BG. The natural history of recurrent optic neuritis. Arch Neurol 2004, 61:1401-1405. 10.1001/archneur.61.9.1401, 15364686.
5. The Optic Neuritis Study Group Multiple sclerosis risk after optic neuritis: final optic neuritis treatment trial follow-up. Arch Neurol 2008, 65:727-732. 2440583, 18541792, The Optic Neuritis Study Group.
6. Optic Neuritis Study Group Long-term brain magnetic resonance imaging changes after optic neuritis in patients without clinically definite multiple sclerosis. Arch Neurol 2004, 61:1538-1541. Optic Neuritis Study Group.
7. Beck RW, Cleary PA, Anderson MM, Keltner JL, Shults WT, Kaufman DI, Buckley EG, Corbett JJ, Kupersmith MJ, Miller NR. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. The Optic Neuritis Study Group. N Engl J Med 1992, 326:581-588. 10.1056/NEJM199202273260901, 1734247.
8. Beck RW, Gal RL, Bhatti MT, Brodsky MC, Buckley EG, Chrousos GA, Corbett J, Eggenberger E, Goodwin JA, Katz B, Kaufman DI, Keltner JL, Kupersmith MJ, Miller NR, Moke PS, Nazarian S, Orengo-Nania S, Savino PJ, Shults WT, Smith CH, Trobe JD, Wall M, Xing D, . Optic Neuritis Study Group Visual function more than 10 years after optic neuritis: experience of the optic neuritis treatment trial. Am J Ophthal 2004, 137:77-83. Optic Neuritis Study Group.
9. Optic Neuritis Study Group Visual function 15 years after optic neuritis: a final follow-up report from the Optic Neuritis Treatment Trial. Ophthalmology 2008, 115:1079-1082. e5, Optic Neuritis Study Group.
10. Osborne BJ, Volpe NJ. Optic neuritis and risk of MS: Differential diagnosis and management. Cleve Clin J Med 2009, 76:181-190. 10.3949/ccjm.76a.07268, 19258465.
11. Kasten E, Wüst S, Behrens-Baumann W, Sabel BA. Computer-based training for the treatment of partial blindness. Nat Med 1998, 4:1083-1087. 10.1038/2079, 9734406.
12. Jung CS, Bruce B, Newman NJ, Biousse V. Visual function in anterior ischemic optic neuropathy: effect of Vision Restoration Therapy - a pilot study. J Neurol Sci 2008, 268:145-149. 10.1016/j.jns.2007.12.001, 18207164.
13. Sahraie A, Trevethan CT, MacLeod MJ, Murray AD, Olson JA, Weiskrantz L. Increased sensitivity after repeated stimulation of residual spatial channels in blindsight. Proc Natl Acad Sci U S A 2006, 103:14971. 10.1073/pnas.0607073103, 1595460, 17000999.
14. Schumacher EH, Jacko JA, Primo SA, Main KL, Moloney KP, Kinzel EN, Ginn J. Reorganization of visual processing is related to eccentric viewing in patients with macular degeneration. Restor Neurol Neurosci 2008, 26:391-402.
15. Jenkins T, Ciccarelli O, Toosy A, Miszkiel K, Wheeler-Kingshott C, Altmann D, Mancini L, Jones S, Plant G, Miller D, Thompson A. Dissecting structure-function interactions in acute optic neuritis to investigate neuroplasticity. Hum Brain Mapp 2010, 31:276-286.
16. Raz N, Dotan S, Benoliel T, Chokron S, Ben-Hur T, Levin N. Sustained motion perception deficit following optic neuritis: Behavioral and cortical evidence. Neurology 2011, 76:2103-2111. 10.1212/WNL.0b013e31821f4602, 21670440.
17. Korsholm K, Madsen KH, Frederiksen JL, Rowe JB, Lund TE. Cortical neuroplasticity in patients recovering from acute optic neuritis. NeuroImage 2008, 42:836-844. 10.1016/j.neuroimage.2008.05.031, 18595736.
18. Korsholm K, Madsen KH, Frederiksen JL, Skimminge A, Lund TE. Recovery from optic neuritis: an ROI-based analysis of LGN and visual cortical areas. Brain 2007, 130:1244-1253. 10.1093/brain/awm045, 17472983.
19. Levin N, Orlov T, Dotan S, Zohary E. Normal and abnormal fMRI activation patterns in the visual cortex after recovery from optic neuritis. NeuroImage 2006, 33:1161-1168. 10.1016/j.neuroimage.2006.07.030, 17011793.
20. Toosy AT, Hickman SJ, Miszkiel KA, Jones SJ, Plant GT, Altmann DR, Barker GJ, Miller DH, Thompson AJ. Adaptive cortical plasticity in higher visual areas after acute optic neuritis. Ann Neurol 2005, 57:622-633. 10.1002/ana.20448, 15852380.
21. Jenkins TM, Toosy AT, Ciccarelli O, Miszkiel KA, Wheeler-Kingshott CA, Henderson AP, Kallis C, Mancini L, Plant GT, Miller DH, Thompson AJ. Neuroplasticity predicts outcome of optic neuritis independent of tissue damage. Ann Neurol 2010, 67:99-113.
22. Schulz KF, Altman DG, Moher D, . for the CONSORT Group CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. PLoS Med 2010, 7:e1000251. 10.1371/journal.pmed.1000251, 2844794, 20352064, for the CONSORT Group.
23. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001, 357:1191-1194. 10.1016/S0140-6736(00)04337-3, 11323066.
24. Friedl-Francesconi H, Binder H. Training in cognitive functions in neurologic rehabilitation of craniocerebral trauma. Z Exp Psychol 1996, 43:1-21.
25. Hasomed GmbH Homepage: Kompensatorisches Training http://www.hasomed.de/de/produkte/rehacom-kognitive therapie/therapieverfahren/gesichtsfeldtraining/kompensatorisches-training.htm.
26. Bach M. The Freiburg Visual Acuity Test-Variability unchanged by post-hoc reanalysis. Graefes Arch Clin Exp Ophthalmol 2007, 245:965-971. 10.1007/s00417-006-0474-4, 17219125.
27. Petzold A, de Boer JF, Schippling S, Vermersch P, Kardon R, Green A, Calabresi PA, Polman C. Optical coherence tomography in multiple sclerosis: a systematic review and meta-analysis. Lancet Neurol 2010, 9:921-932. 10.1016/S1474-4422(10)70168-X, 20723847.
28. OCULUS - Products > Vision Test. Apparatus > Ishihara Tests http://www.oculus.de/en/sites/detail_ger.php?page=497.
29. IReST - International Reading Speed Texts: vision-research.eu - The Gateway to European Vision Research http://www.vision-research.eu/index.php?id=641.
30. Tombaugh TN. Trail Making Test A and B: normative data stratified by age and education. Arch Clin Neuropsychol 2004, 19:203-214. 10.1016/S0887-6177(03)00039-8, 15010086.
31. Psytest - TAP 2.2: Psytest - TAP 2.2 http://www.psytest.net.
32. Cole SR, Beck RW, Moke PS, Gal RL, Long DT, . Optic Neuritis Study Group The National Eye Institute Visual Function Questionnaire: experience of the ONTT. Invest Ophthalmol Vis Sci 2000, 41:1017-1021. Optic Neuritis Study Group.
33. Bullinger M. Erfassung der gesundheitsbezogenen Lebensqualität mit dem SF-36- Health Survey. Bundesgesundheitsblatt-Gesundheitsforschung-Gesundheitsschutz 2000, 43:190-197.
34. Gall C, Mueller I, Gudlin J, Lindig A, Schlueter D, Jobke S, Franke GH, Sabel BA. Formatted: English (U.S.) Vision- and health-related quality of life before and after vision restoration training in cerebrally damaged patients. Restor Neurol Neurosci 2008, 26:341-353.
35. Hamburger Module - HEALTH http://www.hamburger-module.de.
36. Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol 1989, 46:1121-1123. 10.1001/archneur.1989.00520460115022, 2803071.
37. Valko PO, Bassetti CL, Bloch KE, Held U, Baumann CR. Validation of the Fatigue Severity Scale in a Swiss cohort. Sleep 2008, 31:1601-1607. 2579971, 19014080.
38. Richter P, Werner J, Heerlein A, Kraus A, Sauer H. On the validity of the Beck Depression Inventory. Psychopathology 1998, 31:160-168. 10.1159/000066239, 9636945.
39. Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol 2011, 69:292-302. 10.1002/ana.22366, 3084507, 21387374.
40. Kurtzke JF. Rating neurologic impairment in multiple sclerosis. Neurology 1983, 33:1444. 10.1212/WNL.33.11.1444, 6685237.
41. Mueller I, Mast H, Sabel BA. Recovery of visual field defects: a large clinical observational study using vision restoration therapy. Restor Neurol Neurosci 2007, 25:563-572.
42. Horton JC. Disappointing results from Nova Vision's visual restoration therapy. Br J Ophthalmol 2005, 89:1-2. 10.1136/bjo.2004.058214, 1772467, 15615733.
43. Zihl J. Neuropsychologische Rehabilitation. Grundlagen - Diagnostik 1988, 105-131. Springer, Behandlungsverfahren.