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

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ClinicalTrials.gov Identifier: NCT04910204
Recruitment Status : Not yet recruiting
First Posted : June 2, 2021
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Julio Furlan, MD, University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: FES Therapy combined with task-specific training (FEST+TST) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : February 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early FEST + TST
Participants will receive FEST+TST at 3 to 6 months from SCI onset.
Other: FES Therapy combined with task-specific training (FEST+TST)
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.

Experimental: Delayed FEST + TST
Participants will receive FEST+TST at 6 to 9 months from SCI onset.
Other: FES Therapy combined with task-specific training (FEST+TST)
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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04910204


Locations
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Canada, Ontario
Lyndhurst Centre, KITE - TRI UHN
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Julio Furlan KITE, Toronto Rehab-University Health Network
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Responsible Party: Julio Furlan, MD, Neurologist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04910204    
Other Study ID Numbers: 19-6286
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julio Furlan, MD, University Health Network, Toronto:
functional electrical stimulation
task-specific training
upper limb rehabilitation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries