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NCT03854214 · ClinicalTrials.gov registry record · NA
Investigation of Brain Functional MRI as an Early Biomarker of Recovery in Individuals With Spinal Cord Injury
A NA study of Spinal Cord Injuries, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT03854214: Completed NA study of Spinal Cord Injuries, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
NCT03854214 is a NA study of Spinal Cord Injuries that has completed, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 14 participants, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03854214, a NA study of Spinal Cord Injuries, has completed, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Developed by the American Spinal Injury Association (ASIA), the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) provides an overall assessment of motor and sensory function following spinal cord injury. For this study, a single composite ISNCSCI score is reported, which ranges from 0 (indicating the worst overall function) to 324 (indicating normal overall function). The data table presents this composite score as the sole outcome measure for each Arm/Grou
Conditions Studied
Interventions
- DEVICE Functional Electric Stimulation cycling
- DEVICE Passive cycling
Study Locations (1)
Maryland
- Kennedy Krieger Institute, International Center for Spinal Cord Injury - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2023-12-31 |
| Phase | NA |
What the finished NCT03854214 record still lists
NCT03854214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 2 interventions - of which Functional Electric Stimulation cycling is the first listed.
NCT03854214 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03854214 about?
NCT03854214 is a clinical study titled "Investigation of Brain Functional MRI as an Early Biomarker of Recovery in Individuals With Spinal Cord Injury". 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 chan...
What is the current status of trial NCT03854214?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2019-08-01. Estimated completion is 2023-12-31.
What conditions does trial NCT03854214 study?
This clinical trial studies the following conditions: Spinal Cord Injuries.
What interventions are being tested in trial NCT03854214?
The interventions under investigation include: Functional Electric Stimulation cycling (DEVICE), Passive cycling (DEVICE).
Who is sponsoring clinical trial NCT03854214?
This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03854214 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injuries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03854214's enrollment target sits among peer trials
14 159th of 202 higher than 42 of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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