N/A
N=14
Investigation of Brain Functional MRI as an Early Biomarker of Recovery in Individuals With Spinal Cord Injury
Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT03854214 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score — 59.5; 60.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Functional Electric Stimulation cycling (Device); Passive cycling (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score |
64.4; 63.5 | — |
| PRIMARY International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score |
64.4; 63.5 | — |
| PRIMARY International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score |
64.4; 63.5 | — |
| PRIMARY Resting State fMRI Functional Connectivity |
0.533; 0.496 | — |
| PRIMARY Resting State fMRI Functional Connectivity |
0.533; 0.496 | — |
| PRIMARY Resting State fMRI Functional Connectivity |
0.533; 0.496 | — |
| PRIMARY Resting-State fMRI Brain Parcels Outcome Measure: Sensorimotor Network (SMN) Recruitment Coefficient |
0.713; 0.581 | — |
| PRIMARY Resting-State fMRI Brain Parcels Outcome Measure: Sensorimotor Network (SMN) Recruitment Coefficient |
0.713; 0.581 | — |
| PRIMARY Resting-State fMRI Brain Parcels Outcome Measure: Sensorimotor Network (SMN) Recruitment Coefficient |
0.713; 0.581 | — |
Summary
Early detection of response to therapeutic intervention is vital, as it will enable early termination of intervention in non-responding patients, prevent unnecessary financial burden, and allow for early changes to the intervention program. Previous functional MRI (fMRI) studies have shown that changes in brain functional network in spinal cord injury (SCI) patients can occur after as little as one week of intervention. Resting state fMRI (rsfMRI) is a type of fMRI that does not require performance of explicit motor tasks, which makes the method especially suitable for SCI patient population. In this project, the investigators propose that rsfMRI outcome measures can be used to detect early brain functional network changes that occur during intervention, and that the changes will be predictive of recovery in chronic SCI patients.
Eligibility Criteria
Inclusion Criteria
- Adult (18-65 years) men and women of all ethnic groups
- SCI, traumatic
- Thoracic neurological level, without the involvement of lower motor neurons.
- American Spinal Injury Association (ASIA) classification A-D
- Chronic injury: > 6 months from the injury
- Satisfactory general health
- No FES ergometer (i.e. RT300 or equivalent) use within 4 weeks.
- Ability to comply with procedures and follow-up
Exclusion Criteria
- Contra-indication to Magnetic Resonance (MR) study (e.g., cardiac pacemaker, claustrophobia, aneurysm clip, etc.)
- History or clinical evidence of moderate or severe brain injury
- Major spine deformity (e.g. scoliosis, kyphosis, subluxation)
- Movement disorder or severe spasticity preventing ability to lay still for extended periods required for imaging.
- Women who are pregnant
- Concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability
- Unstable long bone fractures of the lower extremities.
- Subjects with history of inability to tolerate electrical stimulation.
Data sourced from ClinicalTrials.gov (NCT03854214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.