Clinical trial NCT04910204: Time-effect of FEST+TST in the Upper-extremity Rehabilitation of Individuals with Traumatic SCI
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: functional electrical stimulation
task-specific training
upper limb rehabilitation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Spinal Cord Independence Measure (SCIM)
timeFrame: Change from baseline SCIM at 3 & 6 months
measure: American Spinal Injury Association (ASIA) Upper-Extremity Motor Score (UEMS)
timeFrame: Change from baseline ASIA UEMS score at 3 & 6 months (ASIA UEMS varies from 0 [complete tetraplegia) to 50 [normal])
measure: ASIA Upper-Extremity Sensory Score (UESS)
timeFrame: Change from baseline ASIA UESS score at 3 & 6 months (ASIA UEMS varies from 0 [complete paralysis) to 50 [normal])
measure: Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP)
timeFrame: Change from baseline GRASSP score at 3 & 6 months (GRASSP score varies from o (complete paralysis) to 148 [normal])
Secondary outcomes:
measure: Needle Electromyography
timeFrame: Change in baseline EMG activity at 3 & 6 months
measure: Repetitive Nerve Stimulation
timeFrame: Change in baseline neuromuscular junction transmission at 3 & 6 months
measure: Nerve Conduction Studies
timeFrame: Change in baseline nerve conduction at 3 & 6 months
measure: F-Wave
timeFrame: Change in baseline F-wave amplitude at 3 & 6 months
measure: H-Reflex
timeFrame: Change in baseline H-reflex amplitude at 3 & 6 months
measure: Somatosensory Evoked Potentials (SSEPs)
timeFrame: Change in baseline SSEPs at 3 & 6 months
measure: Motor Evoked Potentials (MEPs)
timeFrame: Change in baseline MEPs at 3 & 6 months
measure: Functional Magnetic Resonance Imaging (fMRI)
timeFrame: Change in baseline functional connectivity at 3 & 6 months
measure: Laboratorial Assessments (BDNF)
timeFrame: Change in baseline BDNF at 3 & 6 months
measure: Laboratorial Assessments (NTF-3)
timeFrame: Change in baseline NTF-3 at 3 & 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Lyndhurst Centre, KITE - TRI UHN
state: Ontario
Study officials:
affiliation: KITE, Toronto Rehab-University Health Network
name: Julio Furlan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: