Time-effect of FEST+TST in the Upper-extremity Rehabilitation of Individuals With Traumatic SCI

Study Overview
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Brief Summary
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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.

Official Title
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Time Sensitivity of Adaptive Neuroplasticity and Functional Recovery Related to FEST in Combination With TST for Rehabilitation of Upper Extremity Function of Individuals With Tetraplegia

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: FES Therapy combined with task-specific training (FEST+TST)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Subacute stage (<3 months) after traumatic, motor incomplete (AIS C or D), cervical SCI Exclusion Criteria: Contraindications for neurophysiological tests Contraindications for FEST Medical conditions that can limit treatment protocols Other neurological diseases (i.e. peripheral neuropathies) Significant persisting mental illness; Learning disabilities; Substance abuse over 6 months prior to recruitment; Hearing and visual deficits sufficient to affect test performance; Contraindication to MRI scanning

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early FEST + TST<br>Participants will receive FEST+TST at 3 to 6 months from SCI onset. | Other: FES Therapy combined with task-specific training (FEST+TST)<br>* 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.<br>|
| Experimental: Delayed FEST + TST<br>Participants will receive FEST+TST at 6 to 9 months from SCI onset. | Other: FES Therapy combined with task-specific training (FEST+TST)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | Change from baseline GRASSP score at 3 & 6 months (GRASSP score varies from o (complete paralysis) to 148 [normal]) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | Change in baseline NTF-3 at 3 & 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional electrical stimulation, task-specific training, upper limb rehabilitation