MRI Evaluation for Spinal Cord Injury

(CHASM Trial)

Overseen By Allan Aludino

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Pathological fracture, Infection, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

24 Participants Needed

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?

MRI is shown to be very useful in diagnosing spinal cord injuries and predicting recovery. It helps doctors see the severity of the injury and make better treatment decisions, which can lead to improved outcomes for patients. ^{1 2 3 4 5}

Is MRI safe for people with spinal cord injuries?

MRI is generally safe for humans, but in people with spinal cord stimulators, there can be some side effects, especially if the MRI is used in ways not originally intended. For those with spinal cord injuries, MRI can help predict outcomes, but it may also be linked to some adverse events. ^{2 6 7 8 9}

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. ^{3 4 10 11 12}

Research Team

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.

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.

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

Trial Overview The 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

Group I: Arm 1 Experimental Treatment 1 Intervention

Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

United States Department of Defense

Collaborator

Trials

940

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]

MRI is highly effective in diagnosing cervical spinal cord injuries, confirming the cause and severity of spinal cord compression in 30 out of 31 patients, even when radiographs show no bone injury.

Patients with severe spinal cord compression on MRI had poorer neurological recovery, while those without signal changes on T1- and T2-weighted images had a better prognosis, indicating MRI's potential in predicting recovery outcomes.

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]

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

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]

In a study of 459 spinal cord injury patients, those with intrinsic spinal cord signal changes on MRI were more likely to experience adverse events (65% vs. 44.8%) and had a longer hospital stay, indicating that MRI findings can help predict clinical outcomes.

Patients with spinal cord signal changes were less likely to achieve better functional outcomes (AIS D or E) at both baseline and one year follow-up, suggesting that these patients may require more aggressive treatment and education about their prognosis.

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]

A study involving 31 patients with spinal cord stimulation (SCS) systems showed that undergoing MRI scans is generally safe, with no serious complications or harm reported during the procedure.

While some minor issues like increased temperature at the generator site and telemetry difficulties were noted, these did not affect patient safety or lead to reprogramming of the SCS systems, indicating that MRI can be performed safely in these patients.

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]

MRI can effectively monitor the pathological response to spinal cord injuries, showing specific signal intensity patterns that correlate with neurological recovery in patients.

In a rat model of spinal cord injury, distinct MR signal patterns were linked to histological changes, suggesting that MRI can help differentiate injury types and predict recovery outcomes.

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]

In a study of 31 patients with acute spinal cord injury, MRI findings such as cord compression and abnormal signal intensities were identified as important prognostic indicators for recovery.

MRI was effective in predicting patient outcomes and guiding treatment decisions, with specific imaging results correlating with clinical recovery, particularly hyperintensity on T2-weighted images.

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]

MRI is highly recommended for assessing and predicting outcomes in patients with acute spinal cord injuries, with the sagittal T2 sequence being particularly useful for prognostication.

Four distinct MRI patterns (normal, single-level edema, multi-level edema, and mixed hemorrhage and edema) were identified as predictive of neurological outcomes, emphasizing the importance of MRI in guiding clinical decisions.

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

1. United States pubmed.ncbi.nlm.nih.gov

Assessment of gadolinium leakage into traumatic spinal cord lesion using magnet resonance imaging. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Emergency magnetic resonance imaging of cervical spinal cord injuries: clinical correlation and prognosis. [2022]

3. England 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. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

Clinical applicability of magnetic resonance imaging in acute spinal cord trauma. [2022]

5. England 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. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. [2022]

7. Australia 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. [2020]

8. Switzerland 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in patients with spinal neurostimulation systems. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

Histopathologic correlation of magnetic resonance imaging signal patterns in a spinal cord injury model. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Acute spinal cord injury: magnetic resonance imaging correlated with myelopathy. [2004]

12. United States pubmed.ncbi.nlm.nih.gov

The role of magnetic resonance imaging in the management of acute spinal cord injury. [2022]