The Use of Electromagnetic Field (EMF) Treatment in Chronic Spinal Cord Injury (SCI) Patients

The GRASSP is a clinical measure of upper limb impairment, which incorporates the construct of upper limb sensorimotor function. This measurement captures information on upper limb sensorimotor impairment for individuals with tetraplegia and defines neurological status with numerical values, which represent the deficits in a predictive pattern. The GRASSP demonstrates reliability, construct validity, and concurrent validity for use as a standardized upper limb impairment measure for individuals with incomplete SCI (Kalsi-Ryan et al., 2012). Scores can be used to determine relationships between impairment and functional capability of the upper limb.

● Strength (10 muscles of arm \& hand): motor grade 0-5 for each (sum = subtest total, 0-50)

For the secondary outcome measure, the sensibility and prehension subscores will be assessed as follows:

• Dorsal sensation (3 locations): each scored 0-4 (sum = subtest score, 0-12)
• Palmar sensation (3 locations): each scored 0-4 (sum = subtest score, 0-12)
• Prehension ability: 3 grasps (cylindrical, lateral key, tip to tip), each scored 0-4 (sum = 0-12).
• Prehension performance: 6 prehension tasks - pour water from bottle, pick up an object, transfer 9 pegs from board to board, screw four nuts onto bolts, each scored 0-5 (sum = subtest score, 0-30).

This is a system of tests used to define and describe the extent and severity of a subject's spinal cord injury. The subject's grade is based on how much sensation he or she can feel at multiple points on the body, as well as tests of motor function.

For the purposes of this study, only the motor subtests and functions (UEMS \& LEMS) will be considered as a secondary outcome measure.

The full ISNCSCI will be administered and assessed at baseline and end of treatment only for AIS classification purposes.

The Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity (Bohannon \& Smith, 1987). Scoring are as follows:

• 0: No increase in muscle tone
• 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
• 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
• 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
• 3: Considerable increase in muscle tone, passive movement difficult
• 4: Affected part(s) rigid in flexion or extension

The Spinal Cord Independence Measure (SCIM) is a disability profile containing 3 sub-scales developed specifically for people with spinal cord injury (SCI). Through measures across its distinct scales, the profile describes subjects' ability to undertake activities of daily living (Ackerman, Morrison, McDowell, \& Vazquez, 2010). Each area is scored according to its proportional weight in these subjects' general activity. The final score ranges from 0 to 100 (Ackerman et al., 2010). The SCIM includes the following areas of function:

• Self-care (sub-score 0 - 20)
• Respiration and sphincter management (sub-score 0 - 40)
• Mobility (sub-score 0 - 40)

This is a simple method of grading the severity of chronic pain. This questionnaire grades the severity of chronic pain based on its characteristics and its impact on a person's activities (Von Korff, Ormel, Keefe, \& Dworkin, 1992).

Answers are graded on a 0 (no) - 10 (extreme) scale for each of the following questions:

• Rate pain at present time
• Rate of most intense pain in the last 6 months
• Rate of average pain in the last 6 months
• In the past 6 months, how has pain interfered with your daily activities
• In the past 6 months, how has pain interfered with your recreational social and family activities
• In the past 6 months, how has pain interfered with your ability to work

A 32-item questionnaire with items in seven domains. The CUE test displays excellent test/retest reliability, and excellent correlation with impairment and capacity measures in persons with incomplete SCI. Subjects are scored on a 7-point scale representing self-perceived difficulty: 1 indicating totally limited, can't do at all, and 7 indicating not at all limited. Minimum score is 32 and maximum score is 124 (Marino, Shea, \& Stineman, 1998).

Subjects will be asked to complete the following tasks:

• 15 unilateral (left and right) items
• 2 bilateral items
• 3 reaching items
• 4 pulling/pushing items
• 2 wrist items
• 6 hand/finger items
• 2 bilateral items

The measurement system was developed to address the shortage and non-uniformity of subject-reported outcome measures for clinical care and research in SCI rehabilitation. It consists of 19 items, measuring emotional health (depression, anxiety, resilience, positive affect and well-being, grief/loss, self-esteem, stigma, psychological trauma); physical-medical health (bowel management, bladder management, bladder complications, pressure ulcers, pain interference, pain behavior); social participation (ability to participate in social roles and activities, satisfaction with social roles and activities, independence); physical function (basic mobility, self-care, fine motor functioning, wheelchair mobility, ambulation) (Tulsky et al., 2015).

For applicable subjects, MRI scans will be performed, preferably with a 3.0 T Ingenia Philips scanner, according to the follow sequences:

1. Sagittal T2 B. Sagittal STIR C. Sagittal PW (proton density) D. Sagittal T1 E. Sagittal DTI F. Axial T1 G. Axial T2 MRI results will be analyzed to quantify tissue integrity (e.g. white matter, grey matter, cerebrospinal fluid). DTI measurements will be used to identify water movement, which, in the CNS, is often localized within axons, and provides high contrast towards white matter, indicating the quality and quantity of nerve fibers. This endpoint is not obligatory per protocol; failure to complete in contraindicated subjects is not considered a protocol deviation per Good Clinical Practice.