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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 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.

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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.

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

FieldValue
Enrollment Target 14 participants
Start Date 2019-08-01
Est. Completion 2023-12-31
Phase NA

What the Registry Record Tells You About NCT03854214

The ClinicalTrials.gov registry entry for NCT03854214 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (77% lower). The listed sponsor is Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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