Hypothermia for Spinal Cord Injury

Recruiting at 4 trial locations

Overseen By Faiz Ahmad, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Age > 70, Pregnancy, Severe cardiac, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 days

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with recent spinal cord injuries in the neck area. Researchers aim to determine if cooling the body to 33ºC using intravascular hypothermia (also known as Modest Intravascular Hypothermia) can safely aid recovery. Participants will receive either this cooling treatment or standard medical care. Those with non-penetrating neck injuries who can begin treatment within 24 hours may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance recovery methods for spinal cord injuries.

Do I need to stop my current medications for the trial?

The trial information 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 prior data suggests that modest intravascular hypothermia is safe for spinal cord injury patients?

Research has shown that cooling the body to 33ºC, known as mild intravascular hypothermia, has been studied as a treatment for sudden neck spinal cord injuries. In a study with 35 patients, this treatment was generally well-tolerated, and no major safety issues emerged. The cooling process is carefully managed to ensure patient safety. Although still under investigation, early results suggest it is safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using modest intravascular hypothermia for spinal cord injury because it offers a novel approach compared to standard treatments like surgery, corticosteroids, or physical therapy. This technique involves cooling the body to 33 degrees Celsius within 24 hours post-injury and maintaining it for 48 hours. The unique aspect of this treatment is its potential to reduce inflammation and limit further damage to the spinal cord by slowing down the body's metabolic processes. This cooling method could offer a new way to minimize neurological damage and improve recovery outcomes for patients.

What evidence suggests that modest intravascular hypothermia could be effective for spinal cord injury?

Research has shown that gently cooling the body to 33ºC may aid individuals with sudden spinal cord injuries. In this trial, some participants will receive intravascular hypothermia, where the body is cooled to 33ºC and maintained for 48 hours. More than half of the patients in studies demonstrated improved nerve function after using this cooling method. This treatment is considered safe and has been linked to long-term recovery benefits. Additionally, research confirms that the cooling process is carefully controlled to ensure safety during treatment. This promising evidence suggests that gentle cooling could effectively aid recovery after spinal cord injuries. ^{1 3 4 6 7}

Who Is on the Research Team?

Allan Levi, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-70 who have suffered a non-penetrating acute cervical spinal cord injury (from the neck to upper back) and can start treatment within 24 hours. They should be mostly conscious (Glasgow Coma Scale ≥14) with specific injury severities (AIS Grade A - C). Excluded are those over 70, less severe injuries (AIS Grade D), high fever, serious other injuries or conditions like heart issues, bleeding disorders, pregnancy, or certain blood diseases.

Inclusion Criteria

I have an injury that didn't break my skin and may need urgent surgery.

My spinal cord injury is classified between Grade A and C.

Glasgow Coma Scale ≥14

Exclusion Criteria

Hyperthermia on admission (>38.5ºC)

Severe systemic injury

My spinal cord is completely severed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Intravascular hypothermia initiated within 24 hours post-injury and maintained at 33 degrees Celsius for 48 hours

2 days

Follow-up

Participants are monitored for neurological and functional improvements

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Modest Intravascular Hypothermia

Trial Overview The study tests the safety and effectiveness of cooling the body's core temperature to modest levels (33ºC) using intravascular methods in patients with acute cervical spinal cord injuries. It aims to see if this hypothermia treatment improves outcomes after such an injury.

How Is the Trial Designed?

Group I: Hypothermia Experimental Treatment 1 Intervention

Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.

Group II: Control Active Control 1 Intervention

Standard of care medical treatment, specific to each individual.

Modest Intravascular Hypothermia is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Therapeutic Hypothermia for:

• Cardiac Arrest
• Neonatal Encephalopathy
• Stroke

Approved in United States as Therapeutic Hypothermia for:

• Cardiac Arrest
• Neonatal Encephalopathy
• Stroke
• Spinal Cord Injury

Approved in Canada as Therapeutic Hypothermia for:

• Cardiac Arrest
• Neonatal Encephalopathy
• Stroke

Approved in Japan as Therapeutic Hypothermia for:

• Cardiac Arrest
• Neonatal Encephalopathy

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

In a study using a rat model of spinal cord injury, transient systemic hypothermia applied shortly after injury significantly preserved white and gray matter volumes, with increases of 31% and 38% respectively, and four-fold preservation of neurons near the injury site.

Hypothermia also led to improved functional recovery, as indicated by faster improvements in locomotor ability and increased forelimb strength, demonstrating its potential as an effective treatment to reduce damage and neurological deficits after spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic hypothermia improves histological and functional outcome after cervical spinal cord contusion in rats. Lo, TP., Cho, KS., Garg, MS., et al.[2009]

Systemic hypothermia has been shown to improve behavioral outcomes in traumatic spinal cord injury by an average of 24.5%, based on a systematic review and meta-analysis of high-quality studies.

Regional hypothermia also showed a potential benefit with a 26.2% improvement, but results were more variable, suggesting that factors like cooling depth and duration may influence its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of therapeutic hypothermia in animal models of spinal cord injury. Batchelor, PE., Skeers, P., Antonic, A., et al.[2021]

In a study of 35 acute cervical spinal cord injury patients treated with intravascular hypothermia at 33°C for 48 hours, 43% showed improvement in neurological function after an average follow-up of 10 months, indicating potential efficacy of this treatment.

The study reported a 14.2% risk of thromboembolic complications, suggesting that while intravascular hypothermia is generally safe, careful monitoring for complications is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic hypothermia in acute cervical spinal cord injury: a case-controlled study. Dididze, M., Green, BA., Dietrich, WD., et al.[2014]

In a study involving rats with spinal cord injuries, general hypothermia (32°C) resulted in greater temperature drops in both the spinal cord and cortex compared to local hypothermia (30°C), indicating that general hypothermia affects healthy tissues more significantly.

Local hypothermia may be a better option for prolonged treatment of spinal cord injuries, as it minimizes temperature changes in healthy areas like the cortex while still providing neuroprotective benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of local and general hypothermia on temperature profiles of the central nervous system following spinal cord injury in rats. Bazley, FA., Pashai, N., Kerr, CL., et al.[2021]

This study involved 14 patients with acute, complete cervical spinal cord injuries, demonstrating that intravascular cooling can effectively achieve and maintain modest systemic hypothermia (33 degrees C) with minimal variation in body temperature.

The results indicate that while there were some respiratory adverse events, the method of cooling was successful and provides a foundation for future larger studies to evaluate the efficacy of hypothermia in spinal cord injury treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of modest hypothermia after spinal cord injury. Levi, AD., Green, BA., Wang, MY., et al.[2009]

Local hypothermia showed promise in improving recovery after spinal cord injury (SCI) in early animal studies, but clinical trials in the 1970s did not support these findings, leading to decreased interest.

Systemic hypothermia has been successfully used in both animals and humans since the 1980s, with preliminary data indicating that modest systemic hypothermia applied for 48 hours may provide the best therapeutic value, highlighting the need for further large-scale clinical trials to optimize treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of therapeutic hypothermia in the management of acute spinal cord injury. Martirosyan, NL., Patel, AA., Carotenuto, A., et al.[2022]

Modest hypothermia (33 degrees C) has been shown to improve locomotive function and forelimb strength in animal models of spinal cord injury, indicating its potential as a protective treatment.

In clinical settings, modest hypothermia has been found to be safe and achievable for severely injured spinal cord injury patients, supporting its use in acute treatment scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic hypothermia for spinal cord injury. Dietrich, WD.[2009]

In a study involving rats with spinal cord injuries, local hypothermia delivered 30 minutes post-injury did not improve tissue preservation, neuronal health, or locomotor recovery compared to control groups, indicating it may not be an effective treatment.

The research suggests that regional cooling could potentially worsen outcomes by reducing blood flow to the injured area, leading to increased secondary injury rather than providing protective benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of epidural hypothermic saline infusion on locomotor outcome and tissue preservation after moderate thoracic spinal cord contusion in rats. Casas, CE., Herrera, LP., Prusmack, C., et al.[2015]

A new technique using subcutaneous perfusion cooling in rats effectively lowers spinal cord temperature (SCT) to 27 degrees C within 15 minutes without affecting overall body temperature, allowing for targeted spinal cord hypothermia.

This selective spinal cord hypothermia can be maintained for up to 5 hours and offers complete protection against spinal cord injury during periods of normothermic ischemia, demonstrating its potential for therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique of selective spinal cord cooling in rat: methodology and application. Marsala, M., Galik, J., Ishikawa, T., et al.[2019]

Preclinical studies indicate that both systemic and local hypothermia significantly improve neurological recovery following traumatic spinal cord injury (TSCI), suggesting a potential therapeutic benefit.

In clinical trials involving 60 patients, hypothermia treatment was found to be safe, with no cases of neurological deterioration, but its efficacy in promoting neurological recovery remains inconclusive, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypothermia Therapy for Traumatic Spinal Cord Injury: An Updated Review. Ransom, SC., Brown, NJ., Pennington, ZA., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20190669/

Clinical Outcomes Using Modest Intravascular ... All patients were treated with 48 hours of modest (33 degrees C) intravascular hypothermia. The comparison group was composed of 14 age- and injury-matched ...

2. e-neurospine.org e-neurospine.org/journal/view.php?number=1302

Meta-Analysis on the Effect of Hypothermia in Acute Spinal ... This meta-analysis identified that more than 50% of patients showed neurological improvement after hypothermia following acute SCI in general.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02991690

Systemic Hypothermia in Acute Cervical Spinal Cord Injury This study is a prospective multi-center trial designed to determine the safety profile and efficacy of modest (33ºC) intravascular hypothermia following acute ...

4. medrxiv.org medrxiv.org/content/10.1101/2025.10.24.25338722v1.full.pdf

Title Page Safety and Efficacy of Therapeutic Hypothermia ... These data demonstrate careful preparation and control of the cooling and care conditions in the treatment management for cervical spinal cord ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923015374

Review Hypothermic Treatment for Acute Spinal Cord Injury Moderate hypothermia (33°C) introduced systemically by intravascular cooling strategies appears to be safe and provides some improvement of long-term recovery ...

6. withpower.com withpower.com/trial/phase-hypothermia-7-2017-1d590

Hypothermia for Spinal Cord Injury In a study of 35 acute cervical spinal cord injury patients treated with intravascular hypothermia at 33°C for 48 hours, 43% showed improvement in neurological ...

7. semanticscholar.org semanticscholar.org/paper/Clinical-Outcomes-Using-Modest-Intravascular-After-Levi/6ef192425090a8b04edcbdb629fd1e7d52b63e69

[PDF] Clinical Outcomes Using Modest Intravascular ... This study is the first phase 1 clinical trial on the safety and outcome with the use of endovascular hypothermia in the treatment of acute cervical SCI, ...