NG004 in Incomplete Spinal Cord Injury Patients

The ISNCSCI bilateral Upper Extremity Motor Score (UEMS) is determined by examining the muscle function within each of the 5 myotomes encompassing arm and hand function on each side of the body. A score ranging from 0 to 5 can be given to each myotome tested resulting in a maximum score of 50. Higher values indicate better recovery

The SCIM III questionnaire self-care score assesses activities of daily living including feeding, bathing, dressing, and grooming. The self-care score ranges 0-20. The higher scores correspond to better ability to carry out the self-care activities.

The GRASSP is a validated clinical measure of hand function in tetraplegic patients and can assess changes in impairment over time. The GRASSP (Version 2) consists of 4 subtests. The subtest strength (manual muscle testing of 10 muscles of the upper limb) and the subtest prehension performance (grasping test with 4 activities of daily living) will be performed.

WISCI II is a 21-item hierarchical scale of walking based on physical assistance, need of braces and devices, with an ordinal range from 0 (unable to walk) to 20 (walking without assistance for at least 10 meters).

10mWT is a quantitative measurement of lower extremity function. The patient shall walk a set distance (10 meters) at preferred walking speed. The distance covered, the time taken, and the assistance used will be recorded.

6MWT is a test used to determine the locomotor performance. Patients are instructed to walk as far as possible during 6 minutes, with rests being taken whenever required. The distance covered in time or until abort, the walking time until abort, and the number of rests are assessed.

The various lung parameters will include Forced Vital Capacity (FVC), Forced Expiratory volume in one second (FEV1) and peak expiratory flow (PEF).

FVC measures volume in Litter delivered during an expiration made as forcefully and completely as possible starting from full inspiration.

FEV1 assess the volume measured in Litter delivered in the first second of a FVC maneuver. PEF measures highest flow delivered during FVC maneuver (L/min).

Effect on respiratory function measuring respiratory muscle strength: Maximal Inspiratory Pressure [MIP] and Maximum Expiratory Pressure [MEP]. MIP is assessed as the pressure (in cmH2O) during inhalation against a completely occluded airway and is used to evaluate inspiratory muscle strength. MEP a measure of the strength of expiratory muscles, obtained by having the patient exhale as strongly as possible against a resistance. It is assessed as the pressure (in cmH2O) during exhaling.

MRI scans of the spine will be used to characterize the extent of the lesion from the SCI by assessing morphological measures. Analyses of lesion parameters as preserved tissue bridges, lesion volume, lesion length, lesion width and spinal cord atrophy will be performed. Spinal cord atrophy is measured by calculating the cross-sectional area (CSA) of the spinal cord. Quantitative MRI will be used to assess microstructural tissue integrity, as assed by diffusion tensor imaging and quantitative magnetization transfer saturation mapping.

MAS is a 6-point muscle tone assessment scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.

Neuropathic pain will be assessed by the European Multicenter Study About Spinal Cord Injury (EMSCI) Neuropathic Pain Assessment Form (NePAF), which is based on a structured interview using rating scales, and includes specific assessment of the SCI-associated neuropathic pain in terms of location, quality and severity. The pain intensity is rated with an 11-point numeric rating scale with 0 indicating no pain and 10 indicating the worst imaginable pain.