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

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring functional electrical stimulation, task-specific training, upper limb rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lyndhurst Centre, KITE - TRI UHN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Early FEST + TST

Delayed FEST + TST

Arm Description

Participants will receive FEST+TST at 3 to 6 months from SCI onset.

Participants will receive FEST+TST at 6 to 9 months from SCI onset.

Outcomes

Primary Outcome Measures

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

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.

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.

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.

Secondary Outcome Measures

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.

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).

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.

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).

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.

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.

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.

Functional Magnetic Resonance Imaging (fMRI)

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

Laboratorial Assessments (BDNF)

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

Laboratorial Assessments (NTF-3)

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

Full Information

NCT ID

NCT04910204

First Posted

May 7, 2021

Last Updated

May 8, 2023

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT04910204

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2023 (Anticipated)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries

Keywords

functional electrical stimulation, task-specific training, upper limb rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early FEST + TST

Arm Type

Experimental

Arm Description

Participants will receive FEST+TST at 3 to 6 months from SCI onset.

Arm Title

Delayed FEST + TST

Arm Type

Experimental

Arm Description

Participants will receive FEST+TST at 6 to 9 months from SCI onset.

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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 Measure Information:

Title

Spinal Cord Independence Measure (SCIM)

Description

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

Time Frame

Change from baseline SCIM at 3 & 6 months

Title

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

Description

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

Time Frame

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

Title

ASIA Upper-Extremity Sensory Score (UESS)

Description

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

Time Frame

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

Title

Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP)

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Needle Electromyography

Description

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.

Time Frame

Change in baseline EMG activity at 3 & 6 months

Title

Repetitive Nerve Stimulation

Description

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).

Time Frame

Change in baseline neuromuscular junction transmission at 3 & 6 months

Title

Nerve Conduction Studies

Description

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.

Time Frame

Change in baseline nerve conduction at 3 & 6 months

Title

F-Wave

Description

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).

Time Frame

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

Title

H-Reflex

Description

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.

Time Frame

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

Title

Somatosensory Evoked Potentials (SSEPs)

Description

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.

Time Frame

Change in baseline SSEPs at 3 & 6 months

Title

Motor Evoked Potentials (MEPs)

Description

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.

Time Frame

Change in baseline MEPs at 3 & 6 months

Title

Functional Magnetic Resonance Imaging (fMRI)

Description

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

Time Frame

Change in baseline functional connectivity at 3 & 6 months

Title

Laboratorial Assessments (BDNF)

Description

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

Time Frame

Change in baseline BDNF at 3 & 6 months

Title

Laboratorial Assessments (NTF-3)

Description

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

Time Frame

Change in baseline NTF-3 at 3 & 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julio Furlan, MD, PhD

Organizational Affiliation

KITE, Toronto Rehab-University Health Network

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lyndhurst Centre, KITE - TRI UHN

City

Toronto

State/Province

Ontario

Country

Canada

Spinal Cord Injuries

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial