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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: FES Therapy combined with task-specific training (FEST+TST)

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lamisa Etu, BSc; Phone Number: 6285 4165973422; Email: LamisaFaria.Etu@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Lyndhurst Centre, KITE - TRI UHN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Julio Furlan, MD, PhD, KITE, Toronto Rehab-University Health Network

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: functional electrical stimulation; task-specific training; upper limb rehabilitation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 19-6286

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No