The purpose of this study is to investigate whether the timing of delivery of functional electrical stimulation therapy in combination with task-specific training (FEST+TST) following spinal cord injury (SCI) influences functional and neurological recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
The FEST+TST protocol consists of a 1-hour session, 3 to 5 days a week, for up to 12 weeks (40 sessions total) in addition to conventional occupational and physical therapies according to the standard of care.
Lyndhurst Centre, KITE - TRI UHN
Toronto, Ontario, Canada
Spinal Cord Independence Measure (SCIM)
Self-care SCIM subscore (0-20) and total SCIM score (0-100) will be used to assess the degree of disability for individuals with SCI with respect to activities of daily living; higher scores reflect greater degree of functional independence
Time frame: Change from baseline SCIM at 3 & 6 months
American Spinal Injury Association (ASIA) Upper-Extremity Motor Score (UEMS)
International Standards for Neurological Classification of SCI (ISNCSCI) motor and sensory subscores will be used to evaluate degree of impairment.
Time frame: Change from baseline ASIA UEMS score at 3 & 6 months (ASIA UEMS varies from 0 [complete tetraplegia) to 50 [normal])
ASIA Upper-Extremity Sensory Score (UESS)
International Standards for Neurological Classification of SCI (ISNCSCI) motor and sensory subscores will be used to evaluate degree of impairment.
Time frame: Change from baseline ASIA UESS score at 3 & 6 months (ASIA UEMS varies from 0 [complete paralysis) to 50 [normal])
Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP)
The GRASSP is a clinical measure used to evaluate upper limb impairment following SCI across 3 domains: strength, sensation, and prehension.
Time frame: Change from baseline GRASSP score at 3 & 6 months (GRASSP score varies from o (complete paralysis) to 148 [normal])
Needle Electromyography
Disposable monopolar needles will be used to record the insertional activity, spontaneous activity (at rest) and motor unit action potentials (MUAPs) in selected distal muscles (i.e. abductor pollicis brevis and first dorsal interosseous muscles) and proximal muscles (i.e. pronator teres and flexor carpi ulnaris muscles) that are innervated by median and ulnar nerves, respectively, in the dominant (or weaker) upper extremity of each participant.
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Time frame: Change in baseline EMG activity at 3 & 6 months
Repetitive Nerve Stimulation
Stimulation of the median nerve (and ulnar nerve) in the dominant (or weaker) upper extremity of each individual will be applied using a bar electrode with the responses recorded in the abductor pollicis brevis (APB) muscle (and first dorsal interosseous muscle).
Time frame: Change in baseline neuromuscular junction transmission at 3 & 6 months
Nerve Conduction Studies
Supramaximal stimulation will be applied to the dominant (or weaker) upper extremity of each participant to determine the amplitude, distal latency and conduction velocity from the median and ulnar motor responses.
Time frame: Change in baseline nerve conduction at 3 & 6 months
F-Wave
Percutaneous supramaximal stimulation will be applied distally to the median nerve (and ulnar nerve) in the dominant (or weaker) upper extremity of each individual with responses recorded from the abductor pollicis brevis muscle (and abductor digiti minimi muscle).
Time frame: Change in baseline F-wave amplitude at 3 & 6 months
H-Reflex
Percutaneous stimulation will be applied to the median nerve of the dominant (or weaker) upper extremity of each individual with responses recorded from the flexor carpi radialis (FCR) muscle using surface electrodes.
Time frame: Change in baseline H-reflex amplitude at 3 & 6 months
Somatosensory Evoked Potentials (SSEPs)
Electrical stimulation will be applied to the median nerve (and ulnar nerve) in the distal portion of the dominant (or weaker) upper extremity. Recordings will be obtained from the contralateral C3/C4-Fz sites (based in the international 10/20 system) using surface electrodes.
Time frame: Change in baseline SSEPs at 3 & 6 months
Motor Evoked Potentials (MEPs)
Transcranial magnetic stimulation (TMS) will be used to evoke MEPs in the abductor pollicis brevis muscle (and first dorsal interosseous muscle) of the dominant (or weaker) upper extremity with the coil positioned over the contralateral motor cortex.
Time frame: Change in baseline MEPs at 3 & 6 months
Functional Magnetic Resonance Imaging (fMRI)
Functional connectivity changes in the motor and somatosensory cortices and pathways will be examined using resting-state fMRI.
Time frame: Change in baseline functional connectivity at 3 & 6 months
Laboratorial Assessments (BDNF)
Blood will be drawn to quantify the presence of brain derived neurotrophic factor \[BDNF\] in the blood.
Time frame: Change in baseline BDNF at 3 & 6 months
Laboratorial Assessments (NTF-3)
Blood will be drawn to quantify the presence of neurotrophic factor 3 \[NTF-3\] in the blood.
Time frame: Change in baseline NTF-3 at 3 & 6 months