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Behavioural Intervention

FES Cycling for Spinal Cord Injury

N/A

Waitlist Available

Led By Monica A Gorassini, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

AIS A, B, C, D (ASIA Impairment Scale)

Traumatic or non-traumatic SCI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is studying whether starting functional electrical stimulation (FES) cycling early after a new spinal cord injury (SCI) could prevent muscle wasting, pain, or spasticity, and help with spinal cord recovery.

Who is the study for?

This trial is for individuals with a new spinal cord injury (SCI), medically stable, and able to start functional electrical stimulation (FES) cycling between 14-21 days after the injury. The SCI must be at levels C1-L5 and classified as AIS A, B, C, or D. Exclusions include heart problems, spasticity, extreme leg edema or fat tissue, pregnancy, inability to consent, certain implanted stimulators or fractures/dislocations.Check my eligibility

What is being tested?

The study tests if starting FES cycling early (between 14-21 days post-injury) for six months can prevent muscle wasting and aid in neurorecovery compared to starting it three months later or not at all. It will assess benefits on muscle preservation and spinal cord function recovery among three groups: Early-FES group, Delayed-FES group and Control group.See study design

What are the potential side effects?

While specific side effects are not listed for FES cycling in this context since it's generally safe when supervised by medical professionals; potential risks may include skin irritation from electrodes and discomfort from muscle contractions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spinal cord injury is classified as AIS A, B, C, or D.

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I have a spinal cord injury.

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I recently had a spinal cord injury.

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My spinal cord injury is between C1 and L5.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Corticospinal excitability: Change from 0 to 3 months

Corticospinal excitability: Change from 3 months to 6 months

Muscle cross-sectional area thigh and calf: Change from 0 to 3 months

+7 more

Secondary outcome measures

Depression at 3 months

Depression at 6 months

Leg cross-sectional area thigh and calf: Change from 0 to 3 months

+19 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Early FESExperimental Treatment1 Intervention

Receives standard care plus FES cycling in Phase 1 (starting 14 to 21 days after injury and for 3 months) and Phase 2 (from month 3 to month 6 after enrollment).

Group II: Delayed FESExperimental Treatment1 Intervention

Receives standard care only in Phase 1 (considered Control group in Phase 1), and standard care plus FES cycling in Phase 2 (from month 3 to month 6 after enrollment).

Group III: ControlActive Control1 Intervention

Receives standard care only

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Early FES

2021

N/A

~40

Delayed FES

2021

N/A

~40

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

894 Previous Clinical Trials

386,956 Total Patients Enrolled

Royal Alexandra HospitalOTHER

17 Previous Clinical Trials

7,893 Total Patients Enrolled

Glenrose FoundationOTHER

7 Previous Clinical Trials

456 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I able to join this experiment?

"The study is recruiting 36 participants, aged 18 to 80 years old, who have sustained a spinal cord injury (SCI). To be eligible for inclusion in the trial they must meet criteria including traumatic or non-traumatic SCI, acute onset of SCI with an Injury level between C1 and L5 according to the American Spinal Injury Association Impairment Scale (AIS), medically stable without any absolute contraindications and able to start Functional Electrical Stimulation cycling within 14–21 days post-injury."

Answered by AI

Does this research project encompass individuals who have attained the legal age of majority?

"Eligibility requirements for this clinical trial are those aged between 18 and 80. Additionally, there are 138 trials that cater to minors and 732 studies catered toward seniors."

Answered by AI

How many participants may join this research project?

"Confirmed. As evidenced on clinicaltrials.gov, this medical study started recruiting participants from April 21st 2021 and has since been updated once on February 21st 2022. Approximately 36 volunteers are required to be recruited from a single location."

Answered by AI

What core aims are being sought in this experiment?

"Over the course of 3 months, this clinical trial will be assessing spinal cord excitability as its primary outcome. Secondary outcomes to observe include SCI Classification at Baseline using AIS criteria and manual muscle strength testing, followed by Motor Scores at 0-3 month intervals determined by ISNCSCI exams, with a final assessment of SCI Classification at 3 months also based on ASIA Injury Scale parameters."

Answered by AI

Is recruitment for this trial still ongoing?

"The data available on clinicaltrials.gov confirms that this medical trial, which was first announced on April 21st 2021, is actively looking for patients. The study has been recently updated as of February 21st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Early FES Cycling in Acute Spinal Cord Injury for Neuromuscular Preservation and Neurorecovery

Chester Ho 2021. "Early FES Cycling in Acute Spinal Cord Injury for Neuromuscular Preservation and Neurorecovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05255679.