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Chilling the spine: could hypothermia heal paralysis?

NCT ID NCT02991690

Disease control Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This study is testing whether cooling the body to 33°C (just below normal) for 48 hours soon after a cervical spinal cord injury can improve nerve recovery and function. Researchers will enroll 120 adults aged 18-70 with severe but non-penetrating injuries. The cooling is delivered through a catheter in the leg, and participants are monitored for safety and neurological improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hypothermia (body cooling via catheter)
What this could lead to
If it works, this could become a standard early treatment to limit nerve damage and improve movement and independence after spinal cord injury.
What could go wrong
This is an early study without a control group, so results may not prove effectiveness. Cooling carries risks like infection, bleeding, and heart problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2017

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 - 70 years of age * AIS Grade A - C * Glasgow Coma Scale ≥14 * Able to start hypothermia treatment within 24 hours of injury * Non-penetrating injury. Patients urgently taken to the operating room for surgical reduction may also be included. Exclusion Criteria: * Age \> 70 years * AIS Grade D * Hyperthermia on admission (\>38.5ºC) * Severe systemic injury * Severe bleeding * Pregnancy * Coagulopathy * Thrombocytopenia * Known prior severe cardiac history * Blood dyscrasia * Pancreatitis * Reynaud's syndrome * Cord transection

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Conditions

The condition(s) this trial relates to.

Hypothermia injury spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal cord injury, acute

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory University School of Medicine

    TERMINATED

    Atlanta, Georgia, 30303-3049, United States

  • HonorHealth Research Institute with Barrow Brain and Spine

    RECRUITING

    Phoenix, Arizona, 85027, United States

  • Indiana University School of Medicine

    TERMINATED

    Indianapolis, Indiana, 46202-1000, United States

  • Jackson Memorial Hospital

    RECRUITING

    Miami, Florida, 33136, United States

  • Prisma Health - University of South Carolina

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107-5125, United States

  • University of Maryland School of Medicine

    RECRUITING

    Baltimore, Maryland, 21201, United States

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