Head Cooling for Stroke

(COOLHEAD-2a Trial)

Not currently recruiting at 1 trial location

Overseen By William Diprose

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Hypothermia contraindications, Skin lesions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: From time of application in the emergency department until the end of the endovascular thrombectomy procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist stroke patients by using a special cooling cap on the head during a blood clot removal procedure. The goal is to determine if this head cooling method, known as external active conductive head cooling, is safe and can be easily combined with the procedure. Individuals who have experienced a stroke affecting blood flow to the front part of the brain and are scheduled for a clot-removal procedure may find this trial suitable. As an unphased trial, it offers an opportunity to contribute to innovative stroke treatment research.

Will I have to stop taking my current medications?

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 this head cooling technique is safe for stroke patients?

Research has shown that using a cooling method on the head is generally safe for people who have had a severe stroke. One study found that this cooling can raise the systolic blood pressure, but it did not cause any other health issues. Some other concerns, such as very high blood pressure or shivering, have been noted but are rare. Overall, while head cooling can affect body temperature and blood pressure, it is considered a simple and non-invasive treatment with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about external active conductive head cooling for stroke because it offers a novel approach to managing brain temperature, which is crucial during a stroke. Unlike current treatments that focus mainly on restoring blood flow or protecting brain tissue with medication, this method directly cools the head to potentially minimize brain damage. By using a non-invasive cooling technique, it could reduce inflammation and cell death more effectively and safely, offering a new avenue for stroke management that complements existing therapies.

What evidence suggests that external active conductive head cooling is effective for stroke?

Research shows that cooling the brain can improve recovery after a stroke. In one study, a cooling cap lowered brain temperature by about 0.9 °C after 80 minutes. Another study found that cooling methods reached the target brain temperature in 85% of patients. This trial will investigate the effects of external active conductive head cooling, a method of therapeutic hypothermia, to determine its potential benefits in reducing damage during stroke treatments. These findings suggest that cooling the head could help reduce damage during stroke treatments. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients experiencing an acute ischemic stroke who are scheduled to undergo a procedure called endovascular thrombectomy. It's not open to individuals outside of this group.

Inclusion Criteria

I am scheduled for a procedure to remove a clot due to a stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo external active conductive head cooling during endovascular thrombectomy procedures

From time of application in the emergency department until the end of the endovascular thrombectomy procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• External active conductive head cooling

Trial Overview The study is testing the safety and how doable it is to use external active conductive head cooling on patients during their clot removal procedure for stroke.

How Is the Trial Designed?

Group I: Treatment arm Experimental Treatment 1 Intervention

Head cooling

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9580175/

Active conductive head cooling of normal and infarcted brain One study showed that conductive head cooling caused increased systolic blood pressure in patients with severe ischemic stroke, although there was no increased ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12460276/

Non-invasive convective head cooling during stroke ... Safety outcomes included symptomatic bradyarrhythmia, uncontrolled hypertension, or cold-related shivering during head cooling; cervical or ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/0271678X221127088

Expedited brain cooling: Persistent temperature ... After wearing the cooling cap for 80 minutes, the mean brain temperature was reduced by 0.9 °C, while the core body temperature only decreased ...

4. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.112.672923

Induction of Cooling With a Passive Head and Neck ... Therapeutic hypothermia improves clinical outcome after cardiac arrest and appears beneficial in other cerebrovascular diseases.

5. sciencedirect.com sciencedirect.com/science/article/pii/S221413912030086X

Effect of selective brain cooling versus core cooling on ... Regarding cooling methods success in reducing brain temperature, selective brain cooling success in achieving target temperature is (85.0%) of patients compared ...

6. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/0271678X221107988

Active conductive head cooling of normal and infarcted brain Active conductive head cooling is a simple and non-invasive intervention that may slow infarct growth in ischemic stroke.

7. researchgate.net researchgate.net/publication/395801818_Non-invasive_convective_head_cooling_during_stroke_thrombectomy_A_prospective_multi-center_feasibility_trial

Non-invasive convective head cooling during stroke ... Intraarterial, intravenous and active conductive head cooling reduced non-ischemic brain temperature by 4.3 °C, 2.1 °C, and 0.7–0.8 °C ...

8. journalslibrary.nihr.ac.uk journalslibrary.nihr.ac.uk/hta/HTA16450

Systematic review of head cooling in adults after traumatic ... Study found insufficient published evidence to establish whether or not head cooling in patients with traumatic brain injury or stroke improves ...