Spinal Cord InjuriesNCT04910204
Time-effect of FEST+TST in the Upper-extremity Rehabilitation of Individuals with Traumatic SCI
A study testing FES Therapy combined with task-specific training (FEST+TST) in people with Spinal Cord Injuries, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- FES Therapy combined with task-specific training (FEST+TST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subacute stage (<3 months) after traumatic, motor incomplete (AIS C or D), cervical SCI
Who cannot join
- 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;
Show all 9Show fewer
- Substance abuse over 6 months prior to recruitment;
- Hearing and visual deficits sufficient to affect test performance;
- Contraindication to MRI scanning
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- FES Therapy combined with task-specific training (FEST+TST)
- Keywords
- functional electrical stimulation, task-specific training, upper limb rehabilitation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Early FEST + TST | Experimental | Participants will receive FEST+TST at 3 to 6 months from SCI onset. Receives: Other: FES Therapy combined with task-specific training (FEST+TST) |
| Delayed FEST + TST | Experimental | Participants will receive FEST+TST at 6 to 9 months from SCI onset. Receives: Other: FES Therapy combined with task-specific training (FEST+TST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline GRASSP score at 3 & 6 months (GRASSP score varies from o (complete paralysis) to 148 [normal])
Secondary outcomes (10)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change in baseline NTF-3 at 3 & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study startJul 2025 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julio Furlan, MD, University Health Network, Toronto
- Investigators
- Julio Furlan, MD, PhD, Principal investigator, KITE, Toronto Rehab-University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910204
- Sponsor's protocol ID
- 19-6286
- Status last verified
- Dec 2024
- First submitted
- 7 May 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04910204
- Acronym / sponsor ID
- 19-6286
- Conditions
- Spinal Cord Injuries
- Keywords
- functional electrical stimulation, task-specific training, upper limb rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early FEST + TST | Experimental | Other: FES Therapy combined with task-specific training (FEST+TST)Participants will receive FEST+TST at 3 to 6 months from SCI onset. |
| Delayed FEST + TST | Experimental | Other: FES Therapy combined with task-specific training (FEST+TST)Participants will receive FEST+TST at 6 to 9 months from SCI onset. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subacute stage (<3 months) after traumatic, motor incomplete (AIS C or D), cervical SCI
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Delayed FEST + TST, Early FEST + TST |
Primary outcome
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
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.
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.
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.
10 secondary outcomes
Needle Electromyography
Time frame: Change in baseline EMG activity at 3 & 6 months
Repetitive Nerve Stimulation
Time frame: Change in baseline neuromuscular junction transmission at 3 & 6 months
Nerve Conduction Studies
Time frame: Change in baseline nerve conduction at 3 & 6 months
F-Wave
Time frame: Change in baseline F-wave amplitude at 3 & 6 months
H-Reflex
Time frame: Change in baseline H-reflex amplitude at 3 & 6 months
Somatosensory Evoked Potentials (SSEPs)
Time frame: Change in baseline SSEPs at 3 & 6 months
Motor Evoked Potentials (MEPs)
Time frame: Change in baseline MEPs at 3 & 6 months
Functional Magnetic Resonance Imaging (fMRI)
Time frame: Change in baseline functional connectivity at 3 & 6 months
Laboratorial Assessments (BDNF)
Time frame: Change in baseline BDNF at 3 & 6 months
Laboratorial Assessments (NTF-3)
Time frame: Change in baseline NTF-3 at 3 & 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julio Furlan, MD, PhD principal investigator
KITE, Toronto Rehab-University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES Therapy combined with task-specific training (FEST+TST) in people with Spinal Cord Injuries, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lamisa Etu, BSc (4165973422 ext. 6285, LamisaFaria.Etu@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Cord Independence Measure (SCIM) (time frame: Change from baseline SCIM at 3 & 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.