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NCT Number: NCT04910204

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lyndhurst Centre, KITE - TRI UHN

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FES Therapy combined with task-specific training (FEST+TST)

Other

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.

Primary outcomes

  1. Spinal Cord Independence Measure (SCIM)

    Time frame: Change from baseline SCIM at 3 & 6 months

    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

  2. American Spinal Injury Association (ASIA) Upper-Extremity Motor Score (UEMS)

    Time frame: Change from baseline ASIA UEMS score at 3 & 6 months (ASIA UEMS varies from 0 [complete tetraplegia) to 50 [normal])

    International Standards for Neurological Classification of SCI (ISNCSCI) motor and sensory subscores will be used to evaluate degree of impairment.

  3. ASIA Upper-Extremity Sensory Score (UESS)

    Time frame: Change from baseline ASIA UESS score at 3 & 6 months (ASIA UEMS varies from 0 [complete paralysis) to 50 [normal])

    International Standards for Neurological Classification of SCI (ISNCSCI) motor and sensory subscores will be used to evaluate degree of impairment.

  4. Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP)

    Time frame: Change from baseline GRASSP score at 3 & 6 months (GRASSP score varies from o (complete paralysis) to 148 [normal])

    The GRASSP is a clinical measure used to evaluate upper limb impairment following SCI across 3 domains: strength, sensation, and prehension.

Secondary outcomes

  1. Needle Electromyography

    Time frame: Change in baseline EMG activity at 3 & 6 months

    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.

  2. Repetitive Nerve Stimulation

    Time frame: Change in baseline neuromuscular junction transmission at 3 & 6 months

    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).

  3. Nerve Conduction Studies

    Time frame: Change in baseline nerve conduction at 3 & 6 months

    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.

  4. F-Wave

    Time frame: Change in baseline F-wave amplitude at 3 & 6 months

    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).

  5. H-Reflex

    Time frame: Change in baseline H-reflex amplitude at 3 & 6 months

    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.

  6. Somatosensory Evoked Potentials (SSEPs)

    Time frame: Change in baseline SSEPs at 3 & 6 months

    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.

  7. Motor Evoked Potentials (MEPs)

    Time frame: Change in baseline MEPs at 3 & 6 months

    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.

  8. Functional Magnetic Resonance Imaging (fMRI)

    Time frame: Change in baseline functional connectivity at 3 & 6 months

    Functional connectivity changes in the motor and somatosensory cortices and pathways will be examined using resting-state fMRI.

  9. Laboratorial Assessments (BDNF)

    Time frame: Change in baseline BDNF at 3 & 6 months

    Blood will be drawn to quantify the presence of brain derived neurotrophic factor [BDNF] in the blood.

  10. Laboratorial Assessments (NTF-3)

    Time frame: Change in baseline NTF-3 at 3 & 6 months

    Blood will be drawn to quantify the presence of neurotrophic factor 3 [NTF-3] in the blood.

Study contacts

Contact information is provided by the study sponsor or research team.

Lamisa Etu, BSc

CONTACT

[email protected]

4165973422 ext. 6285

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 2, 2021
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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