the clinical initiative

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http://www.spinal-research.org/displ...atabase&id=126



The clinical initiative

Prof D Brooks. Dr N.J. Davey. Prof P Ellaway. Dr H.L. Frankel. Dr A Jamous. Prof C Mathias. Dr P Misra. Dr D Short.



Categories : Clinical assessment. Clinical initiative. Clinical studies. Clinically related.

Start Date: July 00 End Date: July 04

Different sections of the research collaboration are using their expertise to develop accurate tests that record many different functions and abilities. This will ensure that all the effects of treatment will be measured, even if they are small and do not affect all the different groups of neurons in the spinal cord equally.

For safety reasons, the first clinical trials are likely to involve patients with lesions in the lower part of the thoracic spinal cord. This is because of the muscles and other functions that are controlled by this level - the abilities of patients will not be reduced significantly in the unlikely event that treatment causes further damage. For this reason, the Clinical Initiative is developing tests that measure activity in the thoracic spinal cord.

The full effects of spinal cord injury take months to develop, and small changes in function can occur spontaneously even years after injury. To test the assessment techniques the Clinical Initiative undertakes two types of study:


In what are called longitudinal studies, they record the effects from as early as possible after the injury until the injury stabilises.
In base-line studies, they record changes, however minute, in patients with long-term injuries that are apparently stable.
In all cases, state-of-the-art assessment techniques are used to create an accurate picture of each individual's injury.
Teams in the Clinical Initiative are assessing how best to use these techniques to obtain a fuller picture of the severity and level of injury. In some cases, they have found that patients who were originally thought to have a complete motor lesion (i.e. no voluntary muscle function below the injury level) actually have an incomplete lesion when they are assessed using the more sensitive sensory measurements that have been developed.

Developing this range of tests will ensure that changes that occur as a result of treatment can be measured accurately and that results can be compared with subsequent trials. Such assessment protocols are vital to the clinical trials procedure.

Clinical tests
Clinicians routinely use a series of tests to build up a picture of the level of injury and its severity. This assessment involves an expert clinician testing a patient's reflexes, their sensitivity to heat and cold, to sharp and blunt stimulation, and vibration as well as muscle strength.

The aim of this study is to establish how reliable these measurements are - do you get the same results if the same person administers the same tests repeatedly on the same patient (called intra-tester reliability), and do you get the same results if different people administer the same tests to the same patient (called inter-tester reliability).

Ensuring that the results are consistent and reliable is vital to ensure that any changes that are reported in clinical trials are due to the treatment, and not just variability in assessment. By developing proper guidelines, these tests can be used by any group in any country.

Motor studies
A different part of the Clinical Initiative is developing a range of tests to measure motor function (muscle control) above and below the lesion.

Applying a magnetic current to the brain (using a technique called transcranial magnetic stimulation or TMS) causes nerve impulses to pass down the spinal cord and outwards to muscles. This causes changes in muscles that are recorded by placing electrodes either on the skin or into the muscles themselves. One group is investigating how the response of different muscles changes depending on the level of injury.

Tapping the bony vertebrae that surround the spinal cord causes nearby muscles to contract in a reflex response. This reflex remains after injury and members of the same team are testing whether it could also provide useful information on the level and extent of injury.

The Clinical Initiative is developing these techniques as part of a range of tests to measure the exact level of injury and to monitor recovery.

Sensory studies
A technique called Quantitative sensory testing, measures sensitivity to touch, pain, vibration, heat and also changes in blood flow in the skin. Using this sensitive technique on injured individuals, investigators have identified changes in areas of the skin (dermatomes) that were originally thought to be clinically normal.

Pain sensation is another important area that is being assessed - spinal injury is commonly associated with pain. Sometimes, pain above the level of the injury is accompanied by pain below the injury. In addition, there can be an area of supersensitivity at the border between normal sensation and lack of feeling. Members of the Clinical Initiative are interviewing individuals directly using defined procedures to assess pain.

Autonomic studies
Sweating patterns also change following spinal cord injury, as does blood flow to the skin, heart rate and blood pressure. These changes are also being investigated in detail.



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Category - - SELECT A CATEGORY - - ANY CATEGORY Acute (early) Autonomic dysreflexia Chondroitinase Chronic (late) Clinical assessment Clinical initiative Clinical studies Clinically related Electrophysiology Gene therapy Growth factors Guidance channels Immune response Inflammation Inhibitory factors Neuroprotection Olfactory ensheathing glia Plasticity Regeneration Scar Schwann cells Translational studies
Researcher - - ANY RESEARCHER - - Alima Ali David Allen Prof P Anand Prof Patrick Anderson Amirthe Balasubramaniam Dr S Barnett Dr D.L. Becker M. Belci Prof Martin Berry Prof R Birch A Blesch Prof Stephen Bolsover Dr E Bradbury Prof D Brooks Robert Brown Elspeth Brown Dr Arthur Butt Prof T Carlstedt M. Catley MP Coleman Dr Bernard Conway D Corkill Prof Michael Craggs Michael Cronin Dr N.J. Davey R Deumens Prof P Doherty Dr M Dunning Prof P Ellaway Jez Fabes R Fairless C Fang C ffrench-Constant Dr K Fouad Prof Clare Fowler Prof M Frame Dr H.L. Frankel R Franklin Dr Robin Franklin Zhigang He Carole Ho Dr M Htut P Hubbard M. Husain John Iles Isan Izeldin Dr A Jamous Dr Nick Jeffery E Joosten K.S. Karanth Von King B Kwong Dr C Lagourd Dr Andras Lakatos Prof Ann Logan V MacDermid Milan Makwana Dr Daniel Marsh Prof C Mathias Prof S McMahon Dr P Misra M Ovejero-Boglione A Panjwani V. H. Perry John Priestley A.G. Rabchevsky Dr Gennadij Raivich M Ramer Prof PM Richardson J Roskams Dr D Short G.M. Smith M Starkey Marc Tessier-Lavigne Dr D.A. Tonge Prof Lynne Weaver Qin Yang Binhai Zheng




PUBLICATIONS
Davey NJ, Lisle R, Loxton-Edwards B, McGregor AH, Nowicky AV (2002) "Activation of back muscles during abduction of the contralateral arm in man." Spine 27:1355-1360
Davey NJ, Smith HC, Maskill DW, Savic, G & Ellaway PH (1999) "Comparison of input-output patterns in the corticospinal system of normal subjects and incomplete spinal cord injured patients." Experimental Brain Research 127:382-390

Lisle R, Loxton-Edwards B, McGregor AH, Nowicky AV, Davey NJ (2001) "Corticospinal facilitation of contralateral back muscles during arm abduction in man." Journal of Physiology 531P:139P

Kuesgen B, Frankel HL, Anand P. (2002) "Decreased cutaneous sensory axon-reflex vasodilation below the level of lesion in patients with complete spinal cord injury." Somatosensory and Motor Research 19, 149-152

Theodorou S, Catley M, Strutton PH, Davey NJ (2003) "Examination of intercostals muscle facilitation evoked by transcranial magnetic stimulation (TMS) in man." Journal of Physiology 547P:C144

Strutton PH, McGregor AH, Catley M, Davey NJ (2002) "Mechanically-evoked long and short latency reflexes in human erector spinae muscles." Journal of Physiology, 543P:88P

Smith HC, Savic G, Frankel HL, Jamous MA, Ellaway PH, Maskill DW, Davey NJ (2000) "Neurological assessment and corticospinal function studied over time following incomplete spinal cord injury." Spinal Cord 38:292-300

Cariga P, Catley M, Savic G, Frankel HL, Mathias CJ Ellaway PH. "Organisation of the sympathetic skin response in spinal cord injury." Journal of Neurology, Neurosurgery & Psychiatry 2002; 72(3): 356-60.

Davey NJ, Smith HC, Wells E, Maskill DW, Savic G, Ellaway PH, Frankel HL (1998) "Responses of thenar muscles to transcranial magnetic stimulation of the motor cortex in incomplete spinal cord injury patients." Journal of Neurology Neurosurgery and Psychiatry 65:80-87

Cariga P, Catley M, Nowicky AV, Savic G, Ellaway PH, Davey NJ (2002) "Segmental recording of cortical motor evoked potentials from thoracic paravertebral myotomes in complete spinal cord injury." Spine 27:1438-1443.

Davey NJ, Nowicky AV, Zaman R. (2001) "Somatopy of perceptual threshold to cutaneous electrical stimulation in man." Exp Physiol. 86, 127-130

Cariga P, Catley M, Savic G, Frankel HL, Mathias CJ Ellaway PH. "The sympathetic skin response in complete human spinal cord injury." Journal of Physiology 2001; 533P: 68-69.





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