Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP panel: clinical trial outcome measures

Steeves J, Fawcett J, Tuszynski M . Report of International Clinical Trials Workshop on spinal cord injury February 20–21, 2004, Vancouver, Canada. Spinal Cord 2004; 42: 591–597.

Lammertse D et al. Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the International Campaign for Cures of spinal cord Paralysis (ICCP) Panel: Clinical trial design. Spinal Cord 2006 [E-pub ahead of print: 19 December 2006; doi:10.1038/sj.sc.3102010].

Marino R et al. International standards for neurological classification of spinal cord injury (6th edn). J Spinal Cord Med 2003; 26 (Suppl 1): S49–S56.

Bracken MB et al. A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal cord injury. Results of the second National Acute Spinal Cord Injury Study. N Engl J Med 1990; 322: 1405–1411.

Bracken MB et al. Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury. Results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial. National Acute Spinal Cord Injury Study. JAMA 1997; 277: 1597–1604.

Bracken MB et al. Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow-up. Results of the third national acute spinal cord injury randomized controlled trial. J Neurosurg 1998; 89: 699–706.

Geisler FH, Coleman WP, Grieco G, Poonian D, the Sygen® Study Group. Measurements and recovery patterns in a multicenter study of acute spinal cord injury. Spine 2001a; 26: S68–S86.

Geisler FH, Coleman WP, Grieco G, Poonian D, the Sygen® Study Group. The Sygen® multicenter acute spinal cord injury study. Spine 2001b; 26: S87–S98.

Blaustein DM, Zafonte RD, Thomas D, Herbison GJ, Ditunno Jr JF . Predicting recovery of motor complete quadriplegic patients: twenty-four-hour versus 72-h motor index scores. Arch Phys Med Rehabil 1991; 72: 786.

Burns AS, Lee BS, Ditunno Jr JF, Tessler A . Patient selection for clinical trials: the reliability of the early spinal cord injury examination. J Neurotrauma 2003; 20: 477–482.

Fawcett JW, Curt A, Steeves JD, Coleman WP, Tuszynski MH . Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP Panel: Spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials. Spinal Cord 2006 [E-pub ahead of print: 19 December 2006; doi:10.1038/sj.sc.3102007].

Marino RJ, Graves DE . Metric properties of the ASIA motor score: subscales improve correlation with functional activities. Arch Phys Med Rehabil 2004; 85: 1804–1810.

Coleman WP, Geisler FH . Injury severity as a primary predictor of outcome in acute spinal cord injury: retrospective results from a large multicenter clinical trial. Spine J 2004; 4: 373–378.

Waters RL, Adkins RH, Yakura JS, Sie I . Motor and sensory recovery following complete tetraplegia. Arch Phys Med Rehabil 1993; 74: 242–247.

Marino RJ, Ditunno JF, Donovan WH, Maynard F . Neurologic recovery after traumatic spinal cord injury: data from the Model Spinal Cord Injury Systems. Arch Phys Med Rehabil 1999; 80: 1391–1396.

Tuszynski MH, Steeves JD, Fawcett JW, Lammertse D, Kalichman M . Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP Panel: Clinical trial inclusion/exclusion criteria and ethics. Spinal Cord 2006 [E-pub ahead of print: 19 December 2006; doi:10.1038/sj.sc.3102009].

Marino RJ, Herbison GF, Ditunno JF . Peripheral sprouting as a mechanism for recovery in the zone of injury in acute quadriplegia: a single-fiber EMG study. Muscle Nerve 1994; 17: 1466–1468.

Dietz V, Curt A . Neurological aspects of spinal cord repair: promises and challenges. Lancet Neurol 2006; 5: 688–694.

Crozier KS, Graziani V, Ditunno JF, Herbison GJ . Spinal cord injury: prognosis for ambulation based on sensory examination in patients who are initially motor complete. Arch Phys Med Rehabil 1991; 72: 119–121.

Katoh S, el Masry WS . Motor recovery of patients with motor paralysis and sensory sparing following cervical spinal injuries. Paraplegia 1995; 30: 506–509.

Hayes KC et al. Clinical and electrophysiological correlates of quantitative sensory testing in patients with incomplete spinal cord injury. Arch Phys Med Rehabil 2002; 83: 1612.

Ellaway PH et al. Towards improved clinical and physiological assessments of recovery in spinal cord injury: a clinical initiative. Spinal Cord 2004; 42: 325–337.

Nicotra A, Ellaway PH . Thermal perception thresholds: assessing the level of human spinal cord injury. Spinal Cord 2006; 44: 617–624.

Davey NJ, Nowicky AV, Zaman R . Somatopy of perceptual threshold to cutaneous electrical stimulation in man. Exp Physiol 2001; 86: 127–130.

Savic G et al. Quantitative sensory tests (perceptual thresholds) in patients with spinal cord injury. J Rehab Res Dev 2006 (in press).

Savic G, Bergstrom EMK, Frankel HL, Jamous MA, Ellaway PH, Davey NJ . Perceptual thresholds to cutaneous electrical stimulation in patients with spinal cord injury. Spinal Cord 2006; 44: 560–566.

Curt A, Dietz V . Ambulatory capacity in spinal cord injury: Significance of somatosensory-evoked potentials and ASIA protocols in predicting outcome. Arch Rhys Med Rehabil 1997; 78: 39–43.

Curt A, Keck ME, Dietz V . Functional outcome following spinal cord injury: significance of motor-evoked potentials. Arch Phys Med Rehab 1998; 79: 81–86.

Davey NJ, Smith HC, Wells E, Maskill DW, Savic G, Ellaway P . Frankel HL responses of thenar muscles to transcranial magnetic stimulation of the motor cortex in incomplete spinal cord injury patients. J Neurol Neurosurg Psychiatry 1998; 65: 80–87.

Davey NJ, Smith HC, Savic G, Maskill DW, Ellaway PH, Frankel HL . Comparison of input-output patterns in the corticospinal system of normal subjects and incomplete spinal cord injured patients. Exp Brain Res 1999; 127: 382–390.

Kirshblum S, Lim S, Garstang S, Millis S . Electrodiagnostic changes of the lower limbs in subjects with chronic complete cervical spinal cord injury. Arch Phys Med Rehabil 2001; 82: 604–607.

Curt A, Dietz V . Electrophysiological recordings in patients with spinal cord injury: significance for predicting outcome. Spinal Cord 1999; 37: 157–165.

Metz GA, Curt A, van de Meent H, Klusman I, Schwab ME, Dietz V . Validation of the weight-drop contusion model in rats: a comparative study of human spinal cord injury. J Neurotrauma 2000; 17: 1–17.

Diehl P, Kliesch U, Dietz V, Curt A . Impaired facilitation of motor-evoked potentials in incomplete spinal cord injury. J Neurol 2006; 253: 51–57.

Wolfe DL, Hayes KC, Hsieh JT, Potter PJ . Effects of 4-aminopyridine on motor-evoked potentials in patients with spinal cord injury: a double-blinded, placebo-controlled crossover trial. J Neurotrauma 2001; 18: 757–771.

Smith HC et al. Corticospinal function studied over time following incomplete spinal cord injury. Spinal Cord 2000; 38: 292–300.

Laubis-Herrmann U, Dichgans J, Bilow H, Topka H . Motor reorganization after spinal cord injury: evidence of adaptive changes in remote muscles. Restor Neurol Neurosci 2000; 17: 175–181.

Thomas SL, Gorassini MA . Increases in corticospinal tract function by treadmill training after incomplete spinal cord injury. J Neurophysiol 2005; 94: 2844–2855.

Curt A, Schwab ME, Dietz V . Providing the clinical basis for new interventional therapies: refined diagnosis and assessment of recovery after spinal cord injury. Spinal Cord 2004; 42: 1–6.

Kuppuswamy A et al. Motoneurone excitability in back muscles assessed using mechanically evoked reflexes in spinal cord injured patients. J Neurol Neurosurg Psychiatry 2005; 76: 1259–1263.

Claydon VE, Steeves JD, Krassioukov A . Orthostatic hypotension following spinal cord injury: understanding clinical pathophysiology. Spinal Cord 2006; 44: 341–351.

Devivo MJ, Krause JS, Lammertse DP . Recent trends in mortality and causes of death among persons with spinal cord injury. Arch Phys Med Rehabil 1999; 80: 1411–1419.

Garshick E et al. A prospective assessment of mortality in chronic spinal cord injury. Spinal Cord 2005; 43: 408–416.

Nicotra A, Asahina M, Mathias CJ . Skin vasodilator response to local heating in human chronic spinal cord injury. Eur J Neurol 2004; 11: 835–837.

Nicotra A, Young TM, ASahina M, Mathias CJ . The effect of different physiological stimuli on skin vasomotor reflexes above and below the lesion in human chronic spinal cord injury. Neurorehabil Neural Repair 2005b; 19: 325–331.

Cariga P, Catley M, Mathias CJ, Savic G, Frankel HL, Ellaway PH . Organisation of the sympathetic skin response in spinal cord injury. J Neurol Neurosurg Psychiatry 2002; 72: 356–360.

Nicotra A, Catley M, Ellaway PH, Mathias CJ . The ability of physiological stimuli to generate the sympathetic skin response in human chronic spinal cord injury. Restor Neurol Neurosci 2005a; 23: 331–339.

Fehlings MG et al. The optimal radiologic method for assessing spinal canal compromise and cord compression in patients with cervical spinal cord injury Part II: results of a multicenter study. Spine 1999; 24: 605–613.

Bono CM et al. Measurement techniques for lower cervical spine injuries: consensus statement of the Spine Trauma Study Group. Spine 2006; 31: 603–609.

Miyanji F, Furlan JC, Aarabi B, Arnold PM, Fehlings MG . Correlation of MRI findings with neurological outcome in patients with acute cervical traumatic spinal cord injury: a prospective study in 100 consecutive patients. Radiology 2006 (in press).

Schwartz ED, Duda J, Shumsky JS, Cooper ET, Gee J . Spinal cord diffusion tensor imaging and fiber tracking can identify white matter tract disruption and glial scar orientation following lateral funiculotomy. J Neurotrauma 2005; 22: 1388–1398.

Miller DH . Biomarkers and surrogate outcomes in neurodegenerative disease: lessons from multiple sclerosis. J Am Soc Exp NeuroTherapeutics 2004; 1: 284–294.

Ditunno JF, Burns AS, Marino RJ . 2005. Neurological and functional capacity outcome measures: essential to spinal cord injury clinical trials. J Rehab Res Dev 2005; 42 (Suppl 1): 35–41.

Morganti B, Scivoletto G, Ditunno P, Ditunno JF, Molinari M . Walking index for spinal cord injury (WISCI): criterion validation. Spinal Cord 2005; 43: 43–71.

van Hedel HJ, Wirz M, Dietz V . Assessing walking ability in subjects with spinal cord injury: validity and reliability of 3 walking tests. Arch Phys Med Rehabil 2005; 86: 190–196.

van Tuijl JH, Janssen-Potten YJ, Seele HA . Evaluation of upper extremity motor function tests in tetraplegics. Spinal Cord 2002; 40: 51–64.

Gresham GE, Labi ML, Dittmar SS, Hicks JT, Joyce SZ, Stehlik MA . The Quadriplegia Index of Function (QIF): sensitivity and reliability demonstrated in a study of thirty quadriplegic patients. Paraplegia 1986; 24: 3–44.

Marino RJ et al. 1993 Assessing self-care status in quadriplegia: comparison of the quadriplegia index of function (QIF) and the functional independence measure (FIM). Paraplegia 1991; 31: 225–233.

Yavuz N, Tezyurek M, Akyuz M . A comparison of two functional tests in quadriplegia: The quadriplegia index of function and the functional independence measure. Spinal Cord 1998; 36: 832–837.

Sollerman C, Ejeskar A . Sollerman hand function test. A standardized method and its use in tetraplegic patients. Scan. J Plast Recontr Surg Hand Surg 1995; 29: 167–176.

Noreau L, Vachon J . Comparison of three methods to assess muscular strength in individuals with spinal cord injury. Spinal Cord 1998; 36: 716–723.

Fattal C . Motor capacities of upper limbs in tetraplegics: a new scale for the assessment of the results of functional surgery on upper limbs. Spinal Cord 2004; 42: 80–90.

Stineman MG et al. A Prototype Classification System for Medical Rehabilitation. American Rehabilitation Association: Washington DC 1994.

Catz A, Itzkovich M, Agranov E, Ring H, Tamir A . SCIM--spinal cord independence measure: a new disability scale for patients with spinal cord lesions. Spinal Cord 1997; 35: 850–856.

Itzkovich M et al. Reliability of the Catz-Itzkovich Spinal Cord Independence Measure assessment by interview and comparison with observation. Am J Phys Med Rehabil 2003; 82: 267–272.

Catz A et al. A multi-center international study on the spinal cord independence measure, version III: Rasch psychometric validation. Spinal Cord 2006 [E-pub ahead of print: 15 August 2006; doi:10.1038/sj.sc.3101960].

Dijkers MP . Individualization in quality of life measurement: instruments and approaches. Arch Phys Med Rehabil 2003; 84 (Suppl 1): S3–S14.

Young RR . Spasticity: a review. Neurology 1994; 44: 12–20.

Hobart JC et al. Getting the measure of spasticity in multiple sclerosis: the multiple sclerosis spasticity scale (MSSS-88). Brain 2006; 129: 224–234.

Lechner HE, Frotzler A, Eser P . Relationship between self- and clinically rated spasticity in spinal cord injury. Arch Phys Med Rehabil 2006; 87: 15–19.

Pandyan AD, Johnson GR, Price CI, Curless RH, Barnes MP, Rodgers H . A review of the properties and limitations of the Ashworth and Modified Ashworth Scales as measures of spasticity. Clin Rehabil 1999; 13: 373–383.

Siddall PJ, Taylor DA, McClelland JM, Rutkowski SB, Cousins MJ . Pain report and the relationship of pain to physical factors in the first six months following spinal cord injury. Pain 1999; 81: 187–197.

Levendoglu F, Ogun CO, Ozerbil O, Ogun TC, Ugurlu H . Gabapentin is the first ine drug for the treatment of neuropathic pain in spinal cord injury. Spine 2004; 29: 743–751.

Finnerup NB et al. Intraveneous lidocaine relieves spinal cord injury pain. Anesthesiol 2005; 102: 1023–1030.

Finnerup NB, Jensen TS . Spinal cord injury pain – mechanisms and treatment. Eur J Neurol 2004; 11: 73–82.

Jensen MP, Karoly P . Self-report scales and procedures for assessing pain in adults. In: Turk DC, Melzack R (eds). Handbook of Pain Assessment. Guilford Press: New York, NY 1992, pp 152–168.

Bradley S, Galer BS, Jensen MP . Development and preliminary validation of a pain measure spedific to neuropathic pain: the neuropathic pain scale. Rehabil Med 1997; 48: 332–337.

Melzack R . The McGill pain questionnaire: from description to measurement. Anesthesiol 2005; 103: 199–202.

Raichle KA, Osborne TL, Jensen MP, Cardenas D . The reliability and validity of pain interference measures in persons with spinal cord injury. J Pain 2006; 7: 179–186.