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

NCT05255679 | Completed

• 1 other identifier: Pro00100619
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord injury (SCI) is a devastating condition that often leads to paralysis and multiple health problems such as muscle wasting, bone loss and spasticity. Despite the paralysis, functional electrical stimulation (FES) on the skin surface muscles may produce muscle contractions. People who have had an SCI for a long time (chronic SCI) already use FES cycling to exercise, and it is known that it can reverse muscle atrophy and has a wide range of health benefits. Furthermore, animal research suggests that starting exercise training early after new SCI may promote spinal cord recovery. However, not much is known about early FES cycling in humans. Therefore, the investigators propose to study if early FES cycling could prevent muscle wasting, pain or spasticity, and help with spinal cord recovery. The study will recruit 36 participants with a new, acute SCI, between 14 and 21 days after their injury into 3 groups. An Early-FES group starts FES cycling early after injury (between 14 and 21 days after injury), and for a duration of 6 months. A Delayed-FES group starts FES cycling 3 months after enrolling in the study, and for a duration of 3 months. A Control group does not perform FES cycling. This pilot study will allow us to study if early FES cycling, in addition to normal care, has greater benefits on the preservation and recovery of the leg muscles and spinal cord function than delayed FES cycling or standard care only. The results of this pilot study may lead to the development of a larger study with early FES cycling after new SCI.

Conditions

Acute Spinal Cord Injury

Keywords

spinal cord injury; functional electrical stimulation; muscle mass; spasticity; neurorecovery

Outcome Measures

Primary Outcomes (10)

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

  Muscle cross sectional area measured from multiple transverse CT scan slices across thigh and calf

  3 months

• Muscle cross-sectional area thigh and calf: Change from 3 months to 6 months

  Muscle cross sectional area measured from multiple transverse CT scan slices across thigh and calf

  3 months

• Spasticity legs: Change from 0 to 3 months

  Size of the cutaneomuscular reflex (CMR) produced by electrical stimulation of the medial arch of the foot and measured in the electromyogram (EMG) from several muscles in the leg (tibialis anterior, soleus, quadriceps and hamstrings).

  3 months

• Spasticity legs: Change from 3 months to 6 months

  Size of the cutaneomuscular reflex (CMR) produced by electrical stimulation of the medial arch of the foot and measured in the electromyogram (EMG) from several muscles in the leg (tibialis anterior, soleus, quadriceps and hamstrings).

  3 months

• Corticospinal excitability: Change from 0 to 3 months

  Size of the motor evoke potentials (MEP) produced by transcranial magnetic stimulation of the motor cortex, and measured in the EMG of several leg muscles (tibialis anterior, soleus, quadriceps and hamstrings).

  3 months

• Corticospinal excitability: Change from 3 months to 6 months

  Size of the motor evoke potentials (MEP) produced by transcranial magnetic stimulation of the motor cortex, and measured in the EMG of several leg muscles (tibialis anterior, soleus, quadriceps and hamstrings).

  3 months

• Spinal cord excitability: Change from 0 to 3 months

  Hmax/Mmax ratio, based on H-reflex and M-wave measurements in soleus EMG during tibial nerve stimulation, will be quantified as a measure of general spinal cord excitability (sensory transmission and motoneuron excitability)

  3 months

• Spinal cord excitability: Change from 3 months to 6 months

  Hmax/Mmax ratio, based on H-reflex and M-wave measurements in soleus EMG during tibial nerve stimulation, will be quantified as a measure of general spinal cord excitability (sensory transmission and motoneuron excitability)

  3 months

• Muscle strength: Change from 0 to 3 months

  Size of the EMG measured during maximum voluntary contraction in tibialis anterior, soleus, quadriceps and hamstrings.

  3 months

• Muscle strength: Change from 3 months to 6 months

  Size of the EMG measured during maximum voluntary contraction in tibialis anterior, soleus, quadriceps and hamstrings.

  3 months

Secondary Outcomes (22)

• SCI Classification at Baseline

  Baseline

• SCI Classification at 3 months

  3 months

• SCI Classification at 6 months

  6 months

• Motor scores: Change from 0 to 3 months

  3 months

• Motor scores: Change from 3 months to 6 months

  3 months

Study Arms (3)

Early FES

EXPERIMENTAL

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).

Device: Early FES

Delayed FES

EXPERIMENTAL

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).

Device: Delayed FES

Control

NO INTERVENTION

Receives standard care only

Interventions

Early FES DEVICE

FES cycling starting 14-21 days post SCI for 6 months, 3 sessions/week, with gradually increasing duration (15-60 minutes), cadence (20-45 RPM) and resistance; surface stimulation of 3-5 muscle groups per leg; with RT300 Supine or SLSA FES cycle (Restorative Therapies, Inc, Baltimore, MD)

Early FES

Delayed FES DEVICE

FES cycling starting 3 months (+ 14-21 days) post SCI, for 3 months, 3 sessions/week, with gradually increasing duration (15-60 minutes), cadence (20-45 RPM) and resistance; surface stimulation of 3-5 muscle groups per leg; with RT300 Supine or SLSA FES cycle (Restorative Therapies, Inc, Baltimore, MD)

Delayed FES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Traumatic or non-traumatic SCI
• Acute onset of SCI
• Able to start FES cycling 14-21 days post injury
• Injury level C1 - L5
• AIS A, B, C, D (ASIA Impairment Scale)
• Medically stable

You may not qualify if:

• AIS D, able to walk without assistive device
• Unstable spine fractures
• Unstable fractures/dislocations in lower extremities or pelvis
• Pregnancy
• Unable to give consent to participate in the study
• Contraindications for TMS (Transcranial Magnetic Stimulation).
• Lower motor neuron injury with insufficient muscle contraction with FES
• Peripheral nerve or root injury resulting in denervated lower limb muscles
• History of severe hip or knee instability or dislocation/subluxation
• Osteoporosis in lower extremities that could result in fracture from cycling
• Osteoarthritis in lower extremities
• Limited range of motion in hip and knee preventing cycling
• History of epilepsy not effectively managed by medication
• History of heart problems (coronary artery disease / myocardial infarction / congestive heart failure)
• Implanted cardiac demand pacemaker

Sponsors & Collaborators

• University of Alberta: lead
• Royal Alexandra Hospital: collaborator
• Glenrose Foundation: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Muscle Spasticity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chester Ho, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Monica A Gorassini, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Person performing electrophysiology assessments will not know group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized control group design

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: February 24, 2022
• Study Start: April 21, 2021
• Primary Completion: August 30, 2023
• Study Completion: October 31, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)