MRI Evaluation for Spinal Cord Injury
(CHASM Trial)
Recruiting in Palo Alto (17 mi)
BK
Overseen byBrian Kwon, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of British Columbia
Disqualifiers: Pathological fracture, Infection, Pacemaker, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This trial tests if raising blood pressure and preventing blood clots can help with bleeding in the spinal cord after an injury. It focuses on patients with a specific type of spinal injury and aims to manage blood flow and prevent clots to improve recovery. A medication is used to maintain higher blood pressure in patients with recent spinal cord injuries to support better outcomes.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment MRI for spinal cord injury?
Is MRI safe for people with spinal cord injuries?
How does MRI evaluation differ from other treatments for spinal cord injury?
MRI evaluation is unique because it provides a non-invasive way to assess the severity and type of spinal cord injury, helping to predict recovery and guide treatment decisions. Unlike other treatments that directly address the injury, MRI helps in understanding the injury's impact and planning the best course of action.34101112
Research Team
BK
Brian Kwon, MD
Principal Investigator
University of British Columbia
Eligibility Criteria
This trial is for adults aged 19 or older who have suffered a traumatic spinal cord injury between the base of the skull and top of the chest (C0-T1) and are admitted to the study site within a day. They must be able to consent and have certain levels of impairment. Those with MRI-incompatible devices, very high BMI, incomplete assessments, injuries from infection or cancer, or multiple severe injuries can't join.Inclusion Criteria
Able and willing to provide informed consent
You have a certain level of impairment as measured by the Asia Impairment Scale (AIS).
I was admitted to the study site within a day of my injury.
See 2 more
Exclusion Criteria
Presence of pacemaker, aneurysm clip or other device which is a contraindication to MRI
You weigh too much and cannot fit inside the MRI scanner.
I have severe injuries making MRI transport risky.
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo serial MRI scans and receive hemodynamic management with vasopressors and VTE prophylaxis with anticoagulants
2 weeks
Multiple visits for MRI assessments
Follow-up
Participants are monitored for neurological outcomes and hemorrhage quantification
6 months
Treatment Details
Interventions
- MRI (Imaging)
Trial OverviewThe study uses MRI scans to see if treatments right after a spinal cord injury affect bleeding in the spine. It looks at two things: whether raising blood pressure with drugs (vasopressors) and preventing blood clots with anticoagulants influence hemorrhage during the first two weeks post-injury.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vancouver General HospitalVancouver, Canada
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Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
Trials
1506
Patients Recruited
2,528,000+
United States Department of Defense
Collaborator
Trials
940
Patients Recruited
339,000+
Findings from Research
In an exploratory study involving 4 men with acute spinal cord injuries, Gd-DTPA enhancement was first observed on day 4 post-injury, peaking between days 7 and 28, indicating a specific timeline for monitoring injury progression.
The study suggests that MRI with Gd-DTPA can effectively track changes in spinal cord lesions over time, providing valuable insights into the dynamics of secondary injury processes following trauma.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Assessment of gadolinium leakage into traumatic spinal cord lesion using magnet resonance imaging.Kleiser, R., Rademacher, GU., Niedeggen, A., et al.[2015]
MRI performed within hours after cervical spinal cord injuries in 55 patients provides critical prognostic information, revealing that factors like intra-axial hematoma and spinal cord edema are linked to poor neurological outcomes.
Emergency MRI can identify spinal cord compression in nearly half of the patients, guiding timely surgical interventions, which is crucial for improving long-term neurological function.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Emergency magnetic resonance imaging of cervical spinal cord injuries: clinical correlation and prognosis.Selden, NR., Quint, DJ., Patel, N., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
MRI findings in patients with a cervical spinal cord injury who do not show radiographic evidence of a fracture or dislocation.Hayashi, K., Yone, K., Ito, H., et al.[2016]
In a study of 98 patients with acute spinal cord trauma, MRI was found to be significantly more effective than CT in diagnosing various injuries, including soft tissue and intrathecal injuries, detecting 117 more lesions overall.
MRI excelled in visualizing conditions such as bone swelling, posterior ligamentous complex injuries, disk herniation, and spinal cord contusions, highlighting its critical role in assessing the severity and extent of spinal cord injuries.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Clinical applicability of magnetic resonance imaging in acute spinal cord trauma.Morais, DF., de Melo Neto, JS., Meguins, LC., et al.[2022]
MRI is recommended for adult patients with acute spinal cord injury (SCI) before surgical intervention to enhance clinical decision-making, although the quality of evidence is very low.
MRI is also suggested to be performed in the acute period after SCI to better predict neurological outcomes, with the quality of evidence being low.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Role of Baseline Magnetic Resonance Imaging in Clinical Decision Making and Outcome Prediction.Fehlings, MG., Martin, AR., Tetreault, LA., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series.Ragukonis, T.[2022]
Cervical kinematic MRI (KMRI) is a safe and effective diagnostic tool for patients with cervical spinal cord injury without fracture or dislocation (CSCIWFD), as no patients experienced deterioration in neurological function during the study involving 16 participants.
KMRI provided valuable insights for treatment decisions, showing significant improvements in Japanese Orthopedic Association (JOA) scores after surgery, indicating its superiority over static MRI in guiding therapeutic approaches.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Feasibility and Safety of Cervical Kinematic Magnetic Resonance Imaging in Patients with Cervical Spinal Cord Injury without Fracture and Dislocation.Bao, Y., Zhong, X., Zhu, W., et al.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Spinal Cord Signal Change on Magnetic Resonance Imaging May Predict Worse Clinical In- and Outpatient Outcomes in Patients with Spinal Cord Injury: A Prospective Multicenter Study in 459 Patients.Jentzsch, T., Cadotte, DW., Wilson, JR., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Magnetic resonance imaging in patients with spinal neurostimulation systems.De Andres, J., Valía, JC., Cerda-Olmedo, G., et al.[2007]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Histopathologic correlation of magnetic resonance imaging signal patterns in a spinal cord injury model.Weirich, SD., Cotler, HB., Narayana, PA., et al.[2019]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Acute spinal cord injury: magnetic resonance imaging correlated with myelopathy.Yamashita, Y., Takahashi, M., Matsuno, Y., et al.[2004]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The role of magnetic resonance imaging in the management of acute spinal cord injury.Bozzo, A., Marcoux, J., Radhakrishna, M., et al.[2022]
References
Assessment of gadolinium leakage into traumatic spinal cord lesion using magnet resonance imaging. [2015]
Emergency magnetic resonance imaging of cervical spinal cord injuries: clinical correlation and prognosis. [2022]
MRI findings in patients with a cervical spinal cord injury who do not show radiographic evidence of a fracture or dislocation. [2016]
Clinical applicability of magnetic resonance imaging in acute spinal cord trauma. [2022]
A Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Role of Baseline Magnetic Resonance Imaging in Clinical Decision Making and Outcome Prediction. [2022]
Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. [2022]
Feasibility and Safety of Cervical Kinematic Magnetic Resonance Imaging in Patients with Cervical Spinal Cord Injury without Fracture and Dislocation. [2020]
Spinal Cord Signal Change on Magnetic Resonance Imaging May Predict Worse Clinical In- and Outpatient Outcomes in Patients with Spinal Cord Injury: A Prospective Multicenter Study in 459 Patients. [2021]
Magnetic resonance imaging in patients with spinal neurostimulation systems. [2007]
Histopathologic correlation of magnetic resonance imaging signal patterns in a spinal cord injury model. [2019]
Acute spinal cord injury: magnetic resonance imaging correlated with myelopathy. [2004]
The role of magnetic resonance imaging in the management of acute spinal cord injury. [2022]