Status:
COMPLETED
Investigation of Brain Functional MRI as an Early Biomarker of Recovery in Individuals With Spinal Cord Injury
Lead Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ea...
Detailed Description
Early detection of response to spinal cord injury (SCI) therapeutic intervention programs is vital, as it will enable early termination of intervention in non-responding patients, prevent unnecessary ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03854214
Start Date
August 1 2019
End Date
December 31 2023
Last Update
March 10 2025
Active Locations (1)
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1
Kennedy Krieger Institute, International Center for Spinal Cord Injury
Baltimore, Maryland, United States, 21205