Head Cooling for Stroke
(COOLHEAD-2a Trial)
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.12345
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.12678
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo external active conductive head cooling during endovascular thrombectomy procedures
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
Head cooling
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Citations
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 ...
Non-invasive convective head cooling during stroke ...
Safety outcomes included symptomatic bradyarrhythmia, uncontrolled hypertension, or cold-related shivering during head cooling; cervical or ...
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 ...
Induction of Cooling With a Passive Head and Neck ...
Therapeutic hypothermia improves clinical outcome after cardiac arrest and appears beneficial in other cerebrovascular diseases.
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 ...
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_trialNon-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 ...
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 ...
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